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Senate’s US FDA User Fee Bill Answers Biosimilar Interchangeable Exclusivity Questions

 
• By Derrick Gingery

The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.

biologic
The Senate bill would address some biosimilar questions, but others still linger. • Source: Shutterstock

Biosimilar sponsors would gain a tentative approval pathway and shared exclusivity for interchangeable products in the Senate version of the US Food and Drug Administration user fee reauthorization bill, answers to long-pondered questions about the products’ regulation.

The bill, released on 17 May, would rewrite a section of the biosimilar law to state that the FDA...

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Biogenerics After All? US FDA Wants Biosimilar Process To Mirror Generics

 
• By Ramsey Baghdadi

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EU Biosimilar Filings, Opinions And Approvals

 
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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.

Korea’s New Health Minister: ‘Golden Time For The Country To Become A Biopharma Leader’

 
• By Jung Won Shin

Multiple Korean ministries, biopharma companies, and other officials convened at a bio innovation roundtable to discuss strategies to emerge as a global biopharma powerhouse.

US FDA Upheaval Forces User Fee Talks To Begin Later Than Usual

 
• By Derrick Gingery

The fall start of PDUFA and GDUFA negotiations could impact the agreement review process and other parts of the schedule intended to ensure it reaches Congress on time.

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How Will Trump’s Visa Brick, Rubio’s Tariff Fix, Lower Domestic Tax Impact Indian Pharma?

 
• By Vibha Ravi

As US Secretary of State Marco Rubio hints at reconsideration of a punitive Russian oil tariff, Trump adds an H-1B visa brick to his trade wall and India lowers GST on cancer and rare disease drugs, the Pink Sheet considers the impact.

US FDA Gives Leucovorin Unprecedented Path To New Claim Amid ‘Autism Crisis’

 
• By Bridget Silverman

The Trump Administration's autism campaign convinced GSK to submit an sNDA for its no-longer-marketed leucovorin as a treatment for a rare folate deficiency condition with promises to ensure insurance coverage for autism.

Korea’s New Health Minister: ‘Golden Time For The Country To Become A Biopharma Leader’

 
• By Jung Won Shin

Multiple Korean ministries, biopharma companies, and other officials convened at a bio innovation roundtable to discuss strategies to emerge as a global biopharma powerhouse.