EU CHMP OKs Imraldi, Samsung Bioepis’ Biosimilar Of AbbVie’s Humira
The EU’s CHMP has given the green light to Imraldi, Samsung Bioepis’ biosimilar version of AbbVie’s blockbuster adalimumab product Humira. If approved by the European Commission, this will be the South Korean company’s third biosimilar anti-TNF alpha product to gain a marketing authorization in the EU.
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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.
Neurodegenerative and cardiovascular diseases, along with cancer and early feasibility studies, are among the topics to be addressed by consortia interested in taking part in the EU’s latest research partnership.
A new industry report has painted a sobering picture of the UK life sciences sector, which is facing challenges on a number of fronts including clinical research, market access and manufacturing. On the bright side, the report says that implementing the measures in the government’s Life Sciences Vision could make the UK a “world-leading” hub for drug discovery and development.