By Fineline Cube 
China’s Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that it has received Good Manufacturing Practice (GMP) certificates from Belgium’s Federal Agency for Medicines and Health Products (FAMHP) for its production lines of HLX14, a biosimilar of Amgen’s Prolia/Xgeva (denosumab), and HLX11, a biosimilar of Roche’s Perjeta (pertuzumab). This marks a significant milestone in the company’s global expansion and quality assurance.
Biosimilars Developed to Meet Global Standards
Both biosimilars were developed in compliance with the regulatory requirements of China, the EU, and the US. HLX14 is under regulatory review in the EU, US, and Canada for treating osteoporosis in postmenopausal women at high fracture risk. HLX11 is awaiting decisions in China, the EU, US, and Canada for use in combination with trastuzumab and chemotherapy as a neoadjuvant treatment for HER2-positive early/locally advanced/inflammatory breast cancer.
Commercialization Partnership with Organon
Henlius Biotech has out-licensed both products to Organon LLC for commercialization outside China. This partnership covers major markets including the US, EU, and Canada. The GMP certification from Belgium’s FAMHP further solidifies Henlius Biotech’s position in the global biosimilars market and its commitment to providing high-quality therapeutic options to patients worldwide.-Fineline Info & Tech