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Biosimilar Interchangeable Exclusivity Guidance Still Planned Despite Memo Release, US FDA Says

 
• By Derrick Gingery

While many interpretations of the law protecting the first interchangeable biosimilar approved for a reference product are included in a recently released FDA memo, the agency says it has a limited scope.

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Many concepts in the memo could be reflected in upcoming guidance on biosimilar first interchangeable exclusivity. • Source: Shutterstock

More guidance on biosimilar first interchangeable exclusivity is coming that could compliment or expand on information in a memo that included the US Food and Drug Administration’s interpretation of several critical legal questions in the area.

Key Takeaways

  • The FDA still plans to publish guidance on biosimilar first interchangeable exclusivity, where many of the interpretations in the memo could be repeated.

The memo describing the FDA’s first interchangeable exclusivity decision for Boehringer Ingelheim GmbH’s Cyltezo, an interchangeable biosimilar of...

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Off-Patent Drugs Get UK Spotlight, But Picture Is Still ‘Nuanced’

 
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The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. However, Mark Samuels, CEO of Medicines UK, the trade body representing the off-patent industry, says companies are still face multiple hurdles in the market.

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
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A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

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.

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

More from Biosimilars & Generics

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
• By Derrick Gingery

A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

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.

Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By Dean Rudge

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.