What’s Next? Five Things To Look Out For In December
Two Biosimilar Products Face FDA Action Dates
Amgen and Mylan will face US Food and Drug Administration actions dates on two of their biosimilar candidates in December, while ANDA sponsors have date-certain launches for two generic products.
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With the US biosimilar Avastin market now more than a year old, another potential player, Centus Biotherapeutics, finds itself facing trial over its biosimilar candidate. The UK-based joint venture already boasts approval from the European Commission for its FKB238 product, Equidacent.
Teva says the Truxima rituximab biosimilar it sells in the US in partnership with Celltrion has captured a fifth of the market a year after launch, driven in part by its exclusive rheumatoid arthritis indication.
Sun enjoyed a sequential improvement in its US sales in Q2, with finished-dosage turnover in the market up by almost a fifth over the financial first quarter. Meanwhile, the Indian company is hoping to build on early momentum for its psoriasis therapy Ilumya in Japan, leveraging the dermatology expertise of acquired local company Pola.