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 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.
After receiving approval from the Chinese regulatory body for rituximab and trastuzumab, Shanghai Henlius Biotech has now received approval for its HLX03 adalimumab biosimilar rival to Humira. The company has partnered with Wanbang Biopharma for commercialization of HLX03 in China.
Shanghai Henlius Biotech has begun dosing in a Phase I trial for its HLX14 planned biosimilar version of denosumab. Multiple biosimilar developers are vying to take a slice of the market for rivals to Amgen’s Xgeva/Prolia original.