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Biosimilar Switching Studies, Human Factors Analyses Are Flashpoints For Industry

 
• By Sue Sutter

US FDA should offer more flexibility on endpoint in clinical switching studies for interchangeability, generic companies say in comments that also argue a draft guidance recommendation for human factors studies to compare use error rates between products is misplaced.

The US FDA’s recommendations for clinical switching study designs and human factors study testing of proposed interchangeable biosimilar products elicited strong, and sometimes divergent, views from the biopharma industry.

In comments on FDA’s January draft guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” industry groups and companies generally...

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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.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
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Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

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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.

More from Biosimilars & Generics

US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.