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Medicare Coding Change For Biosimilars Could Save $65bn, Firms Say

 
• By Cathy Kelly

Biopharma manufacturers, payers and other stakeholders strongly support changing an Obama-era policy for reimbursing biosimilars under Medicare Part B in comments to the Centers for Medicare and Medicaid Services.

Biosimilar competition could lower Medicare Part B drug spending by $65bn over 10 years if the Centers for Medicare and Medicaid Services would change its approach to reimbursing the products, the manufacturer-supported Biosimilars Forum argued in recent comments to the agency.

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More from Biosimilars

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.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

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

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

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.

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

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

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.