Sino Biopharmaceutical Ltd (HKG: 1177) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Swiss giant Roche’s (SWX: ROG) Herceptin (trastuzumab). This biosimilar drug is intended to treat human epidermal growth factor receptor 2 (HER2) positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.
Herceptin’s Originator and Market History
The originator drug, an anti-HER2 antibody, was first approved in the US in 1998 and subsequently gained approval for use in HER2 positive early/metastatic breast cancer and HER2 positive metastatic gastric cancer in China in 2002. Herceptin was included in China’s National Reimbursement Drug List (NRDL) in 2017, making it more accessible to patients in need.
Competition in the Biosimilar Market
In addition to Sino Biopharmaceutical, Henlius and Hisun Pharma have also registered their biosimilar versions of trastuzumab in China. This competition in the biosimilar market is expected to increase patient access to affordable treatments for HER2 positive cancers, potentially improving outcomes and reducing costs for the healthcare system.-Fineline Info & Tech
