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 to expand its biosimilar portfolio internationally.
Luye’s biosimilar bevacizumab was initially approved in China in 2021 for the treatment of non-small cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), and several other indications. The market approval filing for the drug in Brazil was accepted in April last year. Since the originator drug was first approved in China in 2010, Luye’s biosimilar joins nine other biosimilar versions now available in the market, highlighting the competitive landscape for this important class of oncology drugs.- Flcube.com
