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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Shanghai Henlius Biotech has taken its groundbreaking Chinese rituximab biosimilar a step closer to securing a key rheumatoid arthritis indication.
Henlius has announced plans to seeing its sales shoot up in 2020 based on three new launches.
Shanghai Henlius Biotech has filed with China’s NMPA to add a rheumatoid arthritis indication to its HLX01 approved rituximab biosimilar, despite the originator not being approved for RA in China.