Streamlined European Pathway Needed For Biosimilars To Hit Smaller Targets

Development Costs Are Currently Too High For Smaller-Value Biologics To Be Viable

A more streamlined European regulatory pathway for biosimilars – potentially removing the requirement for confirmatory efficacy trials – is needed for the industry to be able to feasibly offer competition to smaller-value biologic brands, heard delegates to Medicines for Europe’s 18th Biosimilar Medicines Conference.

Medicines for Europe 18th biosimilars conference
Adrian van den Hoven, Esa Heinonen and Isabell Remus (from center to right) discussed the need for a streamlined European pathway for biosimilars • Source: Medicines for Europe

A more streamlined European regulatory pathway for biosimilars, eliminating the requirement for confirmatory Phase III efficacy trials, is needed for smaller-value biologic brands to become viable targets for biosimilar competition, according to European biosimilar industry leaders.

Speaking at European off-patent industry association Medicines for Europe’s 18th Biosimilar Medicines Conference in Brussels, Belgium, in early October, the...

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

More from Biosimilars

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 

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.

EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others

 

Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 

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.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By 

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

More from Biosimilars & Generics

US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings

 

In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.

Generic Drug Office’s Policy Staff Returning To US FDA

 

The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

Aurobindo, MSN Fail To Beat US Nuplazid Patent Expiring In August 2038

 
• By 

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.