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For Generics, EU Reference Product Is Non-Negotiable – Even In Pilot On Parallel Advice

 
• By Urtė Fultinavičiūtė

Acknowledging that it may be a barrier to some extent, EMA’s senior scientific specialist of clinical pharmacology Kevin Blake notes that EU reference medicinal products are a legal requirement for bioequivalence studies and cannot be circumvented.

Businessman thinking on an arrow path.
• Source: Shutterstock

A recent webinar on the FDA-EMA parallel scientific advice (PSA) program for complex generics aimed to increase sponsor interest in the program, but also included some blunt acknowledgements about why it has so far not drawn many participants. 

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More from Biosimilars & Generics

US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

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Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
• By Dave Wallace

The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.