1. Pink Sheet
  2. >>Biosimilars & Generics
  3. >>Biosimilars

The Immortal Humira? In Huge Test For US Biosimilar Policy, Brand May Still Have Edge

 
• By Sarah Karlin-Smith

First Humira biosimilar launches raise worries about holes in US health system that may let the brand product continue to dominate. If Humira biosimilars can’t get a strong foothold, reform to biosimilar policy for medicines reimbursed through the pharmacy benefit may be necessary if the US wants to rely on these products to bring down the cost of brand biologics.

dark forest with fallen tree
If a dozen Humira biosimilars launch, but formulary design doesn’t incentivize uptake, does the biosimilar pathway take a bow? • Source: Shutterstock

The first biosimilar to Humira launches 31 January after decades of success by AbbVie Inc. at fending off competition to their mega blockbuster. By this summer there could be as many as a dozen adalimumab biosimilars on the market kicking off what policy makers envisioned would be billions in savings for the US health care system.

Not so

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

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

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.

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
• By Jessica Merrill

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.