Biosimilars Boost In Europe: 2017 Kicks Off With Three Approvals And Backing From ESMO
With three new approvals in January, the first anticancer about to be authorized, and a vote of confidence from the oncology physicians’ body ESMO, the European biosimilar medicines sector already seems to be picking up momentum in 2017.
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Amgen’s first biosimilar – a competitor to AbbVie’s Humira – and three would-be competitors to Amgen’s own Neulasta are among the 17 biosimilar products that are under evaluation at the European Medicines Agency.
The CHMP has granted a positive opinion to Celltrion’s Truxima, the first biosimilar version of Roche’s cancer treatment, MabThera, but has announced the withdrawal of two pegfilgrastim products.
The move towards greater acceptance of biosimilars is likely to be spurred by new guidance from the Italian regulatory agency AIFA giving more support to biosimilar switching, and by the declaration by a key European medical association that switching infliximab products in IBD patients is “acceptable.”