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Biogen and Samsung Bioepis Win EC Approval for Opuviz Biosimilar in Europe
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US-based Biogen Inc. (NASDAQ: BIIB) and South Korea’s Samsung Bioepis Co., Ltd. have jointly announced that they have received marketing approval from the European Commission (EC) for their Opuviz 40 mg/mL solution for injection in a vial. This biosimilar product, a version of Bayer/Regeneron’s Eylea (aflibercept), is now approved for…
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Sandoz Receives EC Approval for Biosimilar to Eylea for Retinal Diseases
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Switzerland-based pharmaceutical company Sandoz (SWX: SDZ) has announced that it has received marketing approval from the European Commission (EC) for its biosimilar of Bayer/Regeneron’s (ETR: BAYN / NASDAQ: REGN) Eylea (aflibercept). The product is now available in the form of a 2 mg vial kit and pre-filled syringe for intravitreal…
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Huadong Medicine Co., Ltd Receives NMPA Approval for Stelara Biosimilar SaiLeXin
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Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara (ustekinumab), named SaiLeXin. This development marks a significant step forward…
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Gan & Lee Pharmaceuticals Initiates Phase I Clinical Trial for Biosimilar Secukinumab
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Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced the commencement of a Phase I clinical study for GLR1023, a biosimilar candidate to Novartis’ Cosentyx (secukinumab). The company has recently dosed the first patient in the trial, which is focused on evaluating the safety and efficacy of…
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Intas Pharmaceuticals Receives FDA Approval for Biosimilar Stelara, Expanding Treatment Options for Autoimmune Diseases
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Intas Pharmaceuticals Ltd, an Indian pharmaceutical company and partner of China’s Shanghai Henlius Biotech Inc. (HKG: 2696), has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its ustekinumab-srlf. This biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara…
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CSPC Pharmaceutical Secures NMPA Approval for Omalizumab Biosimilar
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’s Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb). CSPC Pharma’s biosimilar product is described as the first omalizumab biosimilar developed…
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Bio-Thera Solutions Ltd Strikes Licensing Deal with Gedeon Richter for BAT1706 Biosimilar
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Guangzhou-based Bio-Thera Solutions Ltd has announced a licensing agreement with Hungary’s Gedeon Richter Plc for BAT1706, its biosimilar version of Roche’s (SWX: RO) Avastin (bevacizumab). Under the agreement, Gedeon Richter will obtain exclusive commercialization rights for the drug in the European Union (EU), the UK, Switzerland, Australia, and other European…
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China’s CDE Releases Draft Guidelines for Biosimilar Drug Labeling
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On September 29, 2024, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) published the “Draft Technical Guidelines for the Preparation of Biosimilar Drug Labels” for public consultation. The document aims to provide detailed technical requirements for the writing of biosimilar drug labels, offering guidance to…
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China’s CDE Issues Draft Guidelines for Biosimilar Pharmaceutical Similarity Research
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The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has released a draft proposal titled “Questions and Answers on Pharmaceutical Similarity Research of Biosimilars,” seeking public feedback until October 9th. This document, applicable to Category 3.3 biologics, provides clarity on common issues and technical requirements for…
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Henlius Biotech’s HLX17 Biosimilar to MSD’s Keytruda Wins NMPA Clinical Trial Approval
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SHANGHAI—Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its HLX17, a biosimilar version of MSD’s (Merck & Co., known as MSD outside the US) blockbuster drug Keytruda (pembrolizumab). The biosimilar targets all indications that the…
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Biocon Biologics Resolves Patent Dispute with J&J, Secures Market Entry for Biosimilar Stelara
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Biocon Biologics Ltd, the biosimilars division of Indian pharmaceutical company Biocon Ltd (BOM: 532523, NSE: BIOCON), has announced the signing of a comprehensive settlement and licensing agreement with Janssen Biotech Inc. and its parent company, Johnson & Johnson (J&J; NYSE: JNJ). This agreement resolves a patent dispute over Bmab 1200,…
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Hybio Pharmaceutical Inks Licensing Deal with Mullan Pharmaceutical for Liraglutide Biosimilar
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BEIJING—Hybio Pharmaceutical Co., Ltd (SHE: 300199), a Chinese biopharmaceutical company, has entered into a licensing agreement with fellow Chinese firm Mullan Pharmaceutical Co., Ltd, concerning the biosimilar version of Novo Nordisk’s Victoza (liraglutide). The agreement encompasses licensing rights, supply, and distribution for Hybio’s biosimilar, which is a glucagon-like peptide 1…
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Bio-Thera Solutions’ BAT2406 Biosimilar Gets Green Light for Clinical Trials in China
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GUANGZHOU—Bio-Thera Solutions (SHA: 688177), a leading biopharmaceutical company based in Guangzhou, has received approval from the National Medical Products Administration (NMPA) to proceed with clinical studies for BAT2406, a biosimilar version of Sanofi’s Dupixent (dupilumab). This monoclonal antibody, which targets interleukin-4 (IL-4) and interleukin-13 (IL-13), is now set to be…
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Henlius Biotech’s Biosimilar Herceptin Approved by Health Canada for Breast and Gastric Cancer Treatments
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Shanghai Henlius Biotech Inc., a leading biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2696), has announced that its UK partner, Accord Healthcare Inc., has received marketing approval from Health Canada. This approval permits the use of Hanquyou (trastuzumab; HLX02), a biosimilar to Roche’s…
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Qilu Pharmaceutical’s Biosimilar Ranibizumab Receives NMPA Approval, Marking a First in China
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Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its biosimilar version of Novartis’s blockbuster drug Lucentis (ranibizumab) has received market approval from the National Medical Products Administration (NMPA). This regulatory nod positions the product as the first biosimilar of its kind to be approved in China. Ranibizumab, a vascular…
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Bio-Thera Solutions Expands Reach with New Licensing Deal for Biosimilar BAT2306
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has entered into a new licensing agreement with Russian firm Pharmapark LLC for BAT2306, a biosimilar of Roche’s Cosentyx (secukinumab). Under the terms of the agreement, Pharmapark will hold exclusive commercialization rights for the drug in Russia and the CIS region. Bio-Thera will oversee the…
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Sihuan Pharmaceutical Secures NMPA Approval for First Biosimilars of Novo Nordisk’s Diabetes Drugs
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Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has secured separate marketing approvals from China’s National Medical Products Administration (NMPA) for its biosimilars of Novo Nordisk (NYSE: NVO)’s Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart), both of which are indicated for the treatment of type 2 diabetes. These…
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Mabwell Bioscience Partners with Cristália for Biosimilar Denosumab in Brazil
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has entered into a licensing agreement with Cristália Produtos Químicos Farmacêuticos LTDA, a Brazil-headquartered pharmaceutical company. Cristália will take on the responsibility for the regulatory submission and commercialization of Mabwell’s biosimilars MAILISHU (9MW0311) and MAIWEIJIAN (9MW0321) in…
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Gan & Lee Pharmaceuticals Gets FDA Green Light for Phase I Clinical Trial of Insulin Aspart Biosimilar
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Gan & Lee Pharmaceuticals (SHA: 603087), a leading pharmaceutical company based in China, has received approval from the U.S. Food and Drug Administration (FDA) to commence a Phase I clinical study for its insulin aspart 30 injection, a biosimilar version of Novo Nordisk (NYSE: NVO)’s pre-mixed NovoMix 30 used in…
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Bio-Thera Solutions’ Bevacizumab Biosimilar Avzivi Receives European Commission Approval
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that its biosimilar version of Roche’s Avastin, Avzivi (bevacizumab), has received market approval from the European Commission (EC). The approval encompasses all existing indications for Avastin, which include the treatment of a range of cancers such as metastatic colorectal cancer, metastatic breast cancer,…
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Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA
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Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic License Applications (BLAs) to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for BAT2206, its biosimilar candidate to Johnson & Johnson’s (J&J, NYSE: JNJ) Stelara (ustekinumab), an auto-immune disease…
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Ocumension Therapeutics and Shandong Boan Biotechnology File for Market Approval of Biosimilar Aflibercept in China
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Ocumension Therapeutics (HKG: 1477) and Shandong Boan Biotechnology Co., Ltd (HKG: 6955) have jointly announced the submission of a market approval filing to the National Medical Products Administration (NMPA) for their co-developed biosimilar version of Bayer’s Eylea (aflibercept). This biosimilar has the potential to be the latest entry in the…
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U.S. Senate Passes Affordable Prescriptions for Patients Act to Limit Patent Thicketing
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In a significant move to curb drug prices, the U.S. Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S-150) last week. This legislation is designed to foster greater competition from generic and biosimilar drugs against their brand-name counterparts. The act’s primary objective is to impose a limit…
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MabPharm’s Biosimilar Infliximab CMAB807 Receives Market Approval in Peru
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MabPharm Ltd (HKG: 2181), a biosimilar specialist in monoclonal antibody (mAb) based in Taizhou, has announced that it has received market approval for CMAB807, a biosimilar version of Johnson & Johnson (J&J)’s Remicade (infliximab), in Peru. The approval encompasses all six indications, which include adult ulcerative colitis, ankylosing spondylitis, rheumatoid…
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Henlius Pharmaceutical’s HLX15 Biosimilar Meets Phase I Clinical Endpoints
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced the successful completion of a Phase I clinical study for HLX15, its biosimilar candidate for Johnson & Johnson’s Darzalex (daratumumab). The trial involved healthy Chinese male subjects and met all pre-set endpoints. Daratumumab is a monoclonal antibody therapy indicated for the…
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China’s Kingfriend Biochemical Acquires U.S.-Listed Adalimumab Biosimilar Yusimry for USD 40 Million
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Nanjing Kingfriend Biochemical Pharmaceutical Co., Ltd (SHA: 603707), a Chinese pharmaceutical company, has announced the acquisition of Yusimry, a biosimilar of adalimumab, from U.S. firm Coherus Biosciences (NASDAQ: CHRS) for a purchase price of USD 40 million. This deal includes the marketing approval, patents, and related assets of the drug,…
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Bio-Thera Solutions’ BAT1806 Biosimilar Receives European Commission Approval
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received market approval from the European Commission (EC) for BAT1806, a biosimilar version of Roche Holding AG’s (OTCM: RHHBY) Actemra/RoActemra (tocilizumab). BAT1806 is indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,…
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Sino Biopharmaceutical Gains NMPA Approval for Liraglutide Biosimilar for Type 2 Diabetes
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Sino Biopharmaceutical Ltd (HKG: 1177), a major player in China’s pharmaceutical industry, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s Victoza (liraglutide), a treatment designed to control blood sugar levels in patients with type 2 diabetes…
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Hybio Pharmaceutical’s Biosimilar Liraglutide Gets Temporary FDA Nod Pending Patent Expiry
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Hybio Pharmaceutical Co., Ltd (SHE: 300199), a Chinese pharmaceutical company, has announced that it has received temporary approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) filing for a biosimilar version of Novo Nordisk’s Victoza (liraglutide). This indicates that the drug has met…
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Bio-Thera Solutions’ Bevacizumab Biosimilar Avzivi Recommended for Approval by EMA’s CHMP
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Bio-Thera Solutions (SHA: 688177), a biopharmaceutical company based in Guangzhou, has received notification that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of its biosimilar product, Avzivi (bevacizumab), which is a biosimilar version of Roche’s Avastin. The CHMP’s positive…
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Amgen’s Bkemv Becomes First Biosimilar to Challenge AstraZeneca’s Soliris with FDA Approval
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Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company, has been granted regulatory approval by the US Food and Drug Administration (FDA) for Bkemv, marking a significant milestone as the first biosimilar in the US to compete with AstraZeneca’s (AZ; NASDAQ: AZN) Soliris (eculizumab). Both the originator drug from AstraZeneca and…
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Bio-Thera Solutions Partners with STADA for European Commercialization of Golimumab Biosimilar
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced a licensing agreement with STADA Arzneimittel AG for BAT2506, a biosimilar version of Johnson & Johnson’s (J&J) Simponi (golimumab). Under this agreement, STADA will secure exclusive commercialization rights for the product across the European Union (EU), the…
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3SBio Secures License for Semaglutide Biosimilar from Hybio Pharmaceutical
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3SBio Inc. (HKG: 1530), a biopharmaceutical company based in China, has announced a licensing agreement with fellow Chinese firm Hybio Pharmaceutical Co., Ltd (SHE: 300199) for the development of a semaglutide biosimilar. Under this agreement, 3SBio will gain access to Hybio’s preclinical technical results for the drug and will be…
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Boan Biotech’s Dulaglutide Biosimilar Accepted for Review by China’s CDE
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Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted its marketing filing for BA5101, a biosimilar version of Trulicity (dulaglutide) for blood glucose control in adults with type 2 diabetes. Trulicity, developed by Eli Lilly, a leading pharmaceutical…
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Henlius Biotech’s Biosimilar Rituximab Receives First Overseas Marketing Approval from Peru
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) of Peru for Hanlikang, its biosimilar version of Roche’s MabThera/Rituxan (rituximab). This marks the first international marketing approval for…
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Boan Biotech’s Dulaglutide Biosimilar Accepted for Review by China’s CDE
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Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted its marketing filing for BA5101, a biosimilar version of Trulicity (dulaglutide) for blood glucose control in adults with type 2 diabetes. Trulicity, originally developed by US pharmaceutical giant Eli…
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Henlius Biotech’s Biosimilar Rituximab Receives First Overseas Marketing Approval from Peru
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) of Peru for Hanlikang, a biosimilar version of Roche’s MabThera/Rituxan (rituximab). This marks the first international marketing approval for…
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Luye Pharma’s Subsidiary Gets NMPA Green Light for Biosimilar Xgeva
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Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a controlling subsidiary of China-based Luye Pharma Group (HKG: 2186), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for BA1102, a biosimilar version of Amgen’s Xgeva (denosumab). BA1102 is now approved for use in treating giant…
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Henlius Biotech’s Denosumab Biosimilar Secures EMA Review for European Market Entry
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that the European Medicine Agency (EMA) has accepted two marketing approval filings for its drug candidate HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab). Denosumab, a recombinant anti-RANKL human monoclonal antibody injection, is utilized for various…
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Sandoz Receives European Commission Approval for Biosimilars Wyost and Jubbonti
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The European Commission (EC) has granted registration approval to Sandoz, a Switzerland-headquartered pharmaceutical company (SWX: SDZ), for its biosimilars Wyost and Jubbonti. These products are reference treatments for Amgen’s (NASDAQ: AMGN) bone treatments Xgeva (denosumab) and Prolia (denosumab), respectively. Sandoz anticipates launching the biosimilars in November 2025. Wyost is indicated…
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Alvotech and Dr. Reddy’s Partner to Challenge Amgen’s Denosumab with Biosimilar AVT03
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Amgen’s (NASDAQ: AMGN) dominance in the bone treatment market with its blockbuster drugs Xgeva and Prolia (denosumab) may face a new challenge as Alvotech (NASDAQ: ALVO), an Iceland-based biopharmaceutical company, has licensed its biosimilar candidate AVT03 to India’s Dr. Reddy’s Laboratories (NYSE: RDY) for the European and US markets. This…
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Fosun Pharmaceutical’s Humira Biosimilar Gains New Indications with NMPA Approval
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its biosimilar drug HanDaYuan has received additional indication approvals from China’s National Medical Products Administration (NMPA). HanDaYuan, a biosimilar version of AbbVie’s Humira (adalimumab), an autoimmune disease therapy, is now approved to treat a wider range of…
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Tonghua Dongbao Pharmaceuticals Begins Clinical Trial for Xultophy Biosimilar
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Tonghua Dongbao Pharmaceuticals (SHA: 600867), a Chinese pharmaceutical company, has announced the dosing of the first patient in a Phase I clinical study for its insulin degludec and liraglutide combination drug. This molecule is a biosimilar version of Novo Nordisk’s Xultophy, the first compound preparation to combine a basal insulin…
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Bio-Thera Solutions’ BAT1806 Receives Positive CHMP Recommendation for EU Approval
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the market approval filing of BAT1806, a biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab). The CHMP’s recommendation…
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US FDA Greenlights Henlius Biotech’s Hanquyou as Biosimilar to Roche’s Herceptin
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Shanghai Henlius Biotech Inc. (HKG: 2696) has achieved a significant milestone with the US Food and Drug Administration’s (FDA) approval for marketing Hanquyou (trastuzumab; HLX02), a biosimilar to Roche (SWX: ROG)’s cancer treatment Herceptin (trastuzumab). The biosimilar will be available in the US under the trade name Hercessi. Originally approved…
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Sandoz’s Partner Samsung Bioepis Scores EC Approval for Stelara Biosimilar Pyzchiva
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Switzerland-headquartered Sandoz (SWX: SDZ) has announced that the European Commission (EC) has granted approval for Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J; NYSE: JNJ) IL-12/23 blocker Stelara (ustekinumab), developed in partnership with South Korea’s Samsung Bioepis. Both biologics are indicated for the treatment of plaque psoriasis, psoriatic arthritis,…
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Luye Pharma’s Subsidiary Boan Biotech Completes Phase III Trial for Eylea Biosimilar BA9101
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Shandong Boan Biotechnology Co., Ltd., a subsidiary of China-based Luye Pharma Group (HKG: 2186), has achieved a significant milestone with the completion of a Phase III clinical study for its proprietary ophthalmology product BA9101. This biosimilar version of Bayer’s Eylea (aflibercept) targets the treatment of recurrent or metastatic esophageal squamous…
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Shanghai Henlius Reports Phase III Success for HLX14 in Osteoporosis Treatment
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Shanghai Henlius Biotech Inc. (HKG: 2696), based in China, has announced that its global, multi-center Phase III clinical trial for HLX14, a biosimilar of Amgen’s Prolia/Xgeva (denosumab), has successfully met its primary endpoints in treating postmenopausal osteoporosis in women at high risk of fracture. The Phase III study aims to…
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Mabwell Bioscience Receives NMPA Approval for Biosimilar Version of Amgen’s Xgeva
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its biosimilar product 9MW0321, a version of Amgen’s Xgeva (denosumab). This makes Mabwell the first company to gain approval for a biosimilar version of the drug in…
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Jiuyuan Gene’s Semaglutide Biosimilar Market Filing Accepted for Review in China
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Hangzhou Jiuyuan Gene Engineering Co., Ltd., based in China, has announced that its market approval filing for a biosimilar version of semaglutide, originally developed by Denmark’s Novo Nordisk, has been accepted for review in China. This biosimilar is aimed at controlling blood glucose levels in patients with type 2 diabetes…
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Shanghai Institute’s Biosimilar Rituximab Approved by NMPA for Lymphoma Treatments
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Shanghai Institute of Biological Products Co., Ltd has announced that its biosimilar version of Roche/Genentech’s Mabthera (rituximab) has received approval from the National Medical Products Administration (NMPA) for the treatment of Non-Hodgkin’s lymphoma, including follicular non-Hodgkin’s lymphoma and CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma, as well as chronic lymphoblastic…
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Dr. Reddy’s Launches Biosimilar Versavo in UK to Challenge Roche’s Cancer Therapy Avastin
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Dr. Reddy’s Laboratories (NYSE: RDY), a prominent Indian pharmaceutical company, has launched its biosimilar Versavo (bevacizumab) in the UK market, presenting a challenge to Roche’s established cancer therapy Avastin. Versavo, a biosimilar to Avastin, has been approved for the treatment of various metastatic cancers, including colorectal cancer, non-squamous non-small cell…
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Bio-Thera Solutions and SteinCares Ink Licensing Deal for LatAm Biosimilar Distribution
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Bio-Thera Solutions (SHA: 688177), a Chinese biopharmaceutical company, has entered into a licensing agreement with SteinCares, a Costa Rican healthcare provider. Under the terms of the deal, SteinCares will obtain exclusive rights to distribute and market two of Bio-Thera’s biosimilars across Brazil and the Latin America (LatAm) region. The financial…
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Henlius Biotech’s HER2 Targeting Biosimilar Secures Thai and Philippine Approvals
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Shanghai Henlius Biotech Inc., (HKG: 2696) a leading China-based biotech firm, has announced that its biosimilar version of Roche’s Herceptin, known as Hanquyou (trastuzumab; HLX02), has been granted marketing authorization in both Thailand and the Philippines. The drug, which is marketed under the trade names TRAZHER and Hertumab in these…
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Sandoz Achieves FDA Milestone with Approval of First US Denosumab Biosimilars
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The US Food and Drug Administration (FDA) has granted Sandoz (SWX: SDZ), a Switzerland-based pharmaceutical company, registration approvals for its biosimilars Wyost (denosumab) and Jubbonti (denosumab). These biosimilars reference and share the same indications as Amgen’s (NASDAQ: AMGN) bone treatments Xgeva and Prolia, respectively. With this approval, Sandoz’s drugs become…
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Fosun Pharmaceutical’s HanDaYuan Seeks NMPA Approval for Expanded Indications in Autoimmune Treatments
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted additional indication approval filings for its biosimilar HanDaYuan, which is modeled after AbbVie’s autoimmune therapy Humira (adalimumab). The company is seeking approval for HanDaYuan to treat polyarthritic juvenile idiopathic…
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Alvotech Scores FDA Nod for Interchangeable High-Concentration Biosimilar to Humira
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The US Food and Drug Administration (FDA) has granted approval to Iceland-based Alvotech’s (NASDAQ: ALVO) Simlandi, marking it as the first interchangeable high-concentration, citrate-free biosimilar to AbbVie’s (NYSE: ABBV) immunosuppressant Humira (adalimumab). Humira faced patent expiration in the US last year, leading to biosimilar competition. Simlandi is approved for various…
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Polpharma Biologics’ Biosimilar Candidate PB016 Shows Comparable Profiles to Takeda’s Entyvio
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Polish biotechnology firm Polpharma Biologics has announced positive results from a comparability study for its late-stage biosimilar candidate PB016, which references Takeda’s (TYO: 4502) inflammatory bowel disease (IBD) blockbuster Entyvio (vedolizumab). The study’s data indicate that PB016 demonstrates similar pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety profiles compared to the…
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Innovent Biologics Posts 65% YOY Growth in Q4 2023 with Over RMB 1.6 Billion in Sales
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Chinese biopharmaceutical company Innovent Biologics Inc., (HKG: 1801) has reported impressive quarterly sales figures, announcing over RMB 1.6 billion (USD 219 million) in product sales for Q4 2023, marking a 65% year-on-year (YOY) increase. In the final quarter of the year, Innovent’s PD-1 inhibitor, Tyvyt (sintilimab injection), maintained strong market…
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Joincare Pharmaceuticals Gets Green Light for Semaglutide Biosimilar Clinical Trial
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Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a Chinese pharmaceutical entity, has announced that it has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for its biosimilar version of Denmark’s major pharmaceutical company, Novo Nordisk’s semaglutide. Joincare is progressing with the development of this product candidate,…
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AbbVie Reports $54.3 Billion in 2023 Revenues Amid Humira Erosion and Segment Variability
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AbbVie (NYSE: ABBV) reported revenues of $54.3 billion for 2023, reflecting a 5.9% year-on-year decline at constant currency rates, as the company grapples with the erosion of its flagship immunosuppressant, Humira (adalimumab). While the neuroscience and aesthetics segments showed resilience with revenue increases of 18.5% and 0.9%, generating $7.7 billion…
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Sandoz Launches Biosimilar Natalizumab in Germany, Challenging Biogen’s Tysabri
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Sandoz, a division of Novartis and a leader in generic drugs and biosimilars headquartered in Switzerland (SWX: SDZ), has announced the launch of Tyruko (natalizumab), the first biosimilar version of Biogen’s (NASDAQ: BIIB) blockbuster Tysabri, in the German market. This move marks a significant advancement in the treatment options for…
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Sandoz Strikes Deal to Acquire Coherus Biosimilar for Ophthalmic Treatment
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Swiss pharmaceutical company Sandoz (SWX: SDZ) has entered into an agreement to purchase Cimerli (ranibizumab), a biosimilar referencing Roche (SWX: RO) unit Genentech’s Lucentis, from US-based Coherus Biosciences (NASDAQ: CHRS). This transaction, valued at a USD 170 million upfront payment, is anticipated to conclude in the first half of 2024.…
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Luye Pharma’s Biosimilar Bevacizumab Gets GMP Certification in Brazil
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced that it has received Good Manufacturing Practice (GMP) certification from Brazil’s National Health Surveillance Agency (ANVISA) for its biosimilar version of Roche’s blockbuster drug Avastin (bevacizumab). This certification marks a significant step forward in Luye’s efforts…
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Bio-Thera Solutions Grants Macter International Exclusive Rights to Avzivi in Pakistan and Afghanistan
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Bio-Thera Solutions (SHA: 688177), a Guangzhou-based biopharmaceutical company, has announced a licensing and commercialization agreement with Macter International Ltd., a company based in Pakistan. Under the terms of the agreement, Bio-Thera will transfer Avzivi (bevacizumab), a biosimilar version of Roche’s Avastin, to Macter. Macter will gain exclusive distribution and marketing…
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Bio-Thera Secures FDA Approval for Avzivi, a Biosimilar to Roche’s Avastin
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received market approval from the U.S. Food and Drug Administration (FDA) for Avzivi (bevacizumab), a biosimilar version of Roche’s (SWX: ROG) Avastin. The approved indications for Avzivi include non-small cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), glioblastoma (GBM), renal…
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Tonghua Dongbao Pharmaceuticals Secures NMPA Approval for Biosimilar Liraglutide
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Tonghua Dongbao Pharmaceuticals (SHA: 600867), a Chinese pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s (NYSE: NVO) GLP-1 receptor agonist Victoza (liraglutide), which is indicated for blood sugar control in type 2 diabetes patients.…
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AbbVie Sues to Protect Rinvoq from Generic Competition in the US Market
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AbbVie (NYSE: ABBV) has initiated legal action in the US to safeguard its blockbuster drug Rinvoq (upadacitinib) from generic market entries by Switzerland-based Sandoz (SWX: SDZ) and Indian pharmaceutical companies Aurobindo Pharma (NSE: AUROPHARMA), Hetero Labs, Intas Pharmaceuticals, and Sun Pharmaceutical (NSE: SUNPHARMA). Despite holding patents on the JAK inhibitor…
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Aurobindo Pharma’s China Plant Secures EU GMP Approval, Eyes Revenue Generation
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India-based Aurobindo Pharma reportedly received EU GMP approval for its China-based manufacturing plant last week, as reported by The Hindu Times. The site is anticipated to start generating revenues from the end of Q4 of the company’s fiscal year (FY) 2024 or early in Q1 FY 2025. Manufacturing and Market…
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Organon Reports Q3 2023 Financials with Mixed Results, Notable Decline in Women’s Health Sales
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US-based Organon (NYSE: OGN) has released its financial results for the third quarter of 2023, showing a 1% year-on-year (YOY) decrease in sales to USD 1.519 billion in constant currency terms. The company’s performance was marked by a 7% decline in Women’s Health sales to USD 418 million, a 10%…
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Pfizer Inc. Reports Q3 2023 Revenue Contraction and Launches Cost Realignment Program
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US pharmaceutical giant Pfizer Inc., (NYSE: PFE) has released its financial results for the third quarter of 2023, reporting a contraction of -41% year-on-year (YOY) in operational terms to USD 13.2 billion, excluding foreign currency fluctuations. The quarter was marked by a net loss of USD 2.38 billion, the company’s…
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Amgen Reports Q3 2023 Financials: 5% Growth Driven by Volume Expansion
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Amgen (NASDAQ: AMGN) has released its Q3 2023 financial results, showcasing a 5% year-on-year (YOY) increase in global sales, reaching USD 6.5 billion. This growth comes despite a 3% decrease in net selling price, primarily fueled by an impressive 11% increase in volume. Notably, this marks the company’s fourth consecutive…
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Boan Biotech Enrolls First Patient in Phase III Study for Opdivo Biosimilar BA1104 in China
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Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its drug candidate BA1104. This marks a significant milestone as BA1104 becomes the first biosimilar to Opdivo (nivolumab) to reach the Phase III stage in…
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Shanghai Henlius Receives GMP Certification from ANVISA for Biosimilar Manufacturing
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) subsidiary Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the receipt of two Good Manufacturing Practice (GMP) certificates from Brazil’s National Health Surveillance Agency (ANVISA). This certification confirms that Henlius’ biologics manufacturing plant located in the Xuhui district of…
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Qilu Pharmaceutical Presents Promising Data for QL1706 and QL1209 at ESMO 2023
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China-based Qilu Pharmaceutical has announced the presentation of clinical data for two of its pipeline candidates, QL1706 and QL1209, at the European Society for Medical Oncology (ESMO) Congress 2023. The data highlights the therapeutic potential of these drugs in treating various forms of cancer, showcasing Qilu’s commitment to innovation in…
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Bio-Thera Solutions’ BAT1806 Receives US FDA Approval as Biosimilar to Actemra/RoActemra
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, announced that its biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), known as BAT1806, has passed review by the US FDA. This milestone marks the approval of BAT1806 for use in the US market to treat a range of…
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Eli Lilly’s Insulin Biosimilar YouBiAn Approved for Diabetes Treatment in China
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US pharmaceutical major Eli Lilly (NYSE: LLY) has announced that it has received market approval from the National Medical Products Administration in China for its insulin glargine product, YouBiAn. This treatment is indicated for adults with type 1 or type 2 diabetes requiring insulin therapy, as well as for children…
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Abbott Expands Biosimilars Portfolio with mAbxience In-License Agreement
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Abbott (NYSE: ABT) has announced the in-licensing of several biosimilar drugs from Spain-based biotechnology firm mAbxience for select markets in Latin America, Southeast Asia, the Middle East, and Africa. mAbxience, which had its majority stake acquired by German group Fresenius (ETR: FRE) from Argentina-based Insud Pharma last year, specializes in…
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Sandoz Receives Positive CHMP Review for Trastuzumab Biosimilar in HER2-Positive Cancers
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Sandoz (SWX: SDZ), the generic and biosimilar drug maker set to separate from Novartis (NYSE: NVS) next month, has received a positive review from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its trastuzumab biosimilar. The biosimilar is intended for use in treating HER2-positive…
