Taizhou-based monoclonal antibody (mAb) biosimilar specialist MabPharm Ltd (HKG: 2181) has announced the filing of a New Drug Application (NDA) for its CMAB009, a biosimilar of Merck KGaA (ETR: MRK)/Bristol-Myers Squibb’s (BMS, NYSE: BMY) cetuximab (trade name: Erbitux). The filing has been accepted for review by the National Medical Products Administration (NMPA), with the targeted indication for the anti-EGFR therapy being metastatic colorectal cancer (mCRC).
Background of Erbitux and Market Opportunity
Erbitux was approved for marketing in the United States in 2004 and received market approval in China a year later. Currently, there is no biosimilar version of the drug approved for marketing in China. This presents a significant opportunity for MabPharm to expand its presence in the market.
Clinical Data and Future Prospects
Existing clinical data has shown that CMAB009 is similar to the originator in terms of efficacy in mCRC, with relatively lower immunogenicity and fewer adverse reactions. Looking ahead, CMAB009 is expected to be extended to the treatment of head and neck squamous cancer, further broadening its potential applications and market reach.
Significance of the NDA Filing
The acceptance of the NDA for CMAB009 marks a significant milestone for MabPharm, as it continues to advance its pipeline of biosimilars. This development highlights the company’s commitment to providing more accessible and effective treatment options for patients with metastatic colorectal cancer and other related conditions.-Fineline Info & Tech
