Henlius Seeks To Add RA Indication To Chinese Rituximab
HLX01 Biosimilar Was First Approved In China Under New Pathway
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.
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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 expand its global footprint and bolster its manufacturing capacity after seeing its sales shoot up in 2020 based on three new launches.
Amgen has received FDA approval and revealed launch plans for its Riabni rituximab rival to Rituxan, setting a price discount in line with Pfizer’s Ruxience version. However, the biosimilar has not been approved for the rheumatoid arthritis indication that is enjoyed by Teva and Celltrion’s higher-priced Truxima version.