EU’s CHMP Expected To OK Another Biosimilar Humira
The European Medicines Agency’s CHMP is expected to give the green light to Samsung Bioepis’ biosimilar version of AbbVie’s anti-TNF-alpha Humira on June 23. Numerous other biosimilar developers have biosimilar adalimumabs under development in a bid to break into the $16bn market for the world’s top-selling drug.
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Presenting equivalence data at EULAR for its biosimilar version of the world's best-selling drug, Humira, Boehringer Ingelheim is optimistic about its position in a crowded field. Karsten Kissel, head of global medical affairs biosimilars for the German group, spoke to Scrip.
US high court says biosimilar sponsors do not have to wait until after FDA approval to start countdown clock for marketing, but patent litigation may impede launches.
Applications for biosimilar medicines are continuing to arrive at the European Medicines Agency, with Sandoz’s versions of AbbVie’s Humira and Janssen’s Remicade having just been accepted for filing. This brings to 13 the number of biosimilars under evaluation; seven more are awaiting a marketing authorization decision from the European Commission.