Sandoz Files Biosimilar Humira & Remicade In EU; 13 Products Now Under Evaluation By CHMP
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.
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The European Medicines Agency has given the thumbs-up to Insulin lispro Sanofi, the first biosimilar version of Lilly’s diabetes drug Humalog. It has also green-lighted three more biosimilar rituximab products from Celltrion, which already has EU approval for one version of the originator product, Roche’s MabThera.
The UK drugs regulator says it needs to make sure that companies do not “deprioritize” GB approval applications while a new “international reliance framework” is being developed.
Delegates at the European Health Forum Gastein outlined the challenges facing an international effort to improve access to costly new medicines across the World Health Organization’s European region, insisting that the key issues had to be addressed “collectively” and without “finger pointing.”