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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. 

EMA’s senior scientific specialist of clinical pharmacology Kevin Blake began his session – titled “EMA and International Engagement for Generics...

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Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
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US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings

 
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In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.

More from Biosimilars & Generics

Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
• By Dean Rudge

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US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
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FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.