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 announced that China’s NMPA has accepted the firm’s filing for its HLX14 denosumab biosimilar. Meanwhile, the company has also announced dosing the first patient in a Phase II clinical trial of its novel HLX10 anti-PD-1 monoclonal antibody.
In an exclusive interview with Generics Bulletin, Dr. Scott Liu, co-founder, and CEO of Chinese biosimilars and biologics specialist Shanghai Henlius Biotech, has set out his vision for the firm’s future in China and around the globe.
Bio-Thera Solutions has launched its first product in China, with its Qletli adalimumab biosimilar representing the first Humira rival to be approved under the country’s biosimilars pathway and just the second biosimilar approved overall.