EMA Shift To Drop Biosimilar Studies Shows Industry Has ‘Moved The Needle’
Medicines For Europe Responds To Agency Concept Paper On Comparative Efficacy Trials
Responding to a recent EMA concept paper on re-evaluating the need for comparative efficacy studies to support biosimilar applications, Medicines for Europe says the development shows that cumulative experiences with biosimilars have “moved the needle” in terms of regulatory science.
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Samsung Bioepis has celebrated becoming the first developer to obtain approvals for both Lucentis and Eylea biosimilars, after its SB15 aflibercept candidate was approved in Korea.
The Global Generics & Biosimilars Awards returns to Milan this October, recognizing the top achievements across the generics, biosimilars and value added medicines industries. Entries are now open and you can also book tickets to attend, both of which are free of charge.
‘Fast Forward Four Or Five Years, We’re Going To Look Very Different’ – Rosemont Chief Eyes ‘Transformative’ International M&A
UK-based liquids specialist Rosemont Pharmaceuticals is on the lookout for M&A opportunities, particularly as it looks to build up its business in the US, chief executive Howard Taylor tells Generics Bulletin in an exclusive interview.