EU Biosimilar Filings, Opinions And Approvals
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
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Hot on the heels of its new antimalarial strategy, the World Health Organization has given a “strong” recommendation for the use of a fixed-dose artemisinin combination therapy from Shin Poong and the Medicines for Malaria Venture that should see it being more widely used in disease-endemic countries.
The latest initiative under the UK’s Life Sciences Vision is intended to fund the development of innovative treatments while saving the National Health Service “millions of pounds.”
New, more flexible regulatory approaches will be needed to deal with the integrated therapies coming through company pipelines, and the European Medicines Agency should play a “key orchestrating role” in smoothing the way, says Sabine Atzor, Roche’s head of EU regulatory policies.