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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What Would An EU ‘Regulatory Sandbox’ Bring To New Drug Development?
Digital health, AI, real-world evidence and “proactive learning” are key components of the EU’s proposals for new ways of regulating novel medicines, but only time will tell which products might benefit from the flexibilities offered by the “regulatory sandbox.”
European Parliament Wants EU-Wide Pull Incentive Scheme For New Antimicrobials
The three major EU institutions are all calling for urgent action to tackle antimicrobial resistance, with the emphasis very much on incentives for the development of novel medicines and a reduction in overall consumption of antibiotics.
WHO To Review Impact Of Mechanism For Tackling Substandard & Falsified Drugs
Recent incidents of illness and death caused by contaminated cough syrups show that there is a need to review the “member state mechanism” that is intended to coordinate efforts to tackle poor quality medical products, the World Health Organization says.