Biosimilars continue to ride high this week with an EU approval and a licensing deal of Bevacizumab biosimilar. Samsung Bioepis received European Commissions’ greenlight for marketing Avastin (Bevacizumab) biosimilar, Aybintio, in the EU, thereby making it the third Avastin biosimilar to get an EU approval but will have to wait until 2020 for the EU patent for bevacizumab to expire along with Pfizer and Amgen.
The approval is based on a comprehensive data package on analytic, pharmacokinetic and clinical findings, in addition to pharmacology and toxicology information, indicating that the biosimilar product has no clinically meaningful differences from the reference product Avastin. The approval encompasses all approved indications for the reference product – metastatic carcinoma of the colon or rectum, metastatic breast cancer, non–small cell lung cancer, advanced or metastatic renal cell cancer, fallopian tube, epithelial ovarian, and primary peritoneal cancer, and cervical cancer. The BLA application to the US FDA is currently under review.
In South-East Asia, Chinese biosimilar manufacturers have been making quite some noise with new product launches and global aspirations. The latest news comes from Bio-Thera solutions, who announced a license agreement with BeiGene for distribution and supply of the former’s bevacizumab biosimilar, BAT-1706 in China, including Hong Kong, Macau, and Taiwan. An application has already been filed by Bio-Thera solutions with the China National Medical Products Administration (NMPA) and expects to file marketing applications in the US and Europe by the end of 2020. Upon reaching regulatory and commercial milestones, Bio-Thera will receive milestone payments close to the value of USD 165 million and royalties on future net product sales. BeiGene has a significant presence, and a robust pipeline in oncology in the Chinese market, the latest partnership is aligned with their broad portfolio focus on solid tumor indications.