Chinese Biosimilar Boom Is Heralded By First Approval
Approval of China's first rituximab biosimilar under new pathway gives developers much-needed boost and an opening to the international market for made-in-China biosimilars helped by favorable regulatory policy changes at home.
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The US FDA has accepted a BLA for Henlius’ trastuzumab biosimilar candidate HLX02, marking another step in the Chinese company’s push for the US oncology market
Henlius has focused its efforts on becoming a fully-fledged biopharmaceutical company during 2021, moving away from its roots as a biosimilar drug company.
Henlius says it can now pursue a “differentiated strategy” for its HLX01 rituximab biosimilar in China, after winning approval for a key rheumatoid arthritis indication from the NMPA.