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

Biosimilar Makers Take On ‘Huge’ Barriers To A Sustainable European Market

 
• By Ian Schofield

The biosimilars industry in Europe will face a struggle over the next few years as the longer-term sustainability of the market is threatened by a dearth of big biologic patent expiries and a growing number of new innovative drugs targeted at smaller patient populations. The Pink Sheet spoke to Adrian van den Hoven and Marc-Alexander Mahl of the generics and biosimilar medicines association, Medicines for Europe, about the sector’s key challenges and how they can be tackled.

Hurdles
Barriers stand in the way of a sustainable biosimilars market

Biosimilar industry leaders are gearing up to tackle the threats to the longer-term sustainability of the sector caused by divergences in biosimilar usage across Europe, a dearth of near-term biologic expiries, and a shift towards smaller patient populations. But they say the industry cannot solve these problems on its own, and later this year they will be pushing the new European Parliament and European Commission to look afresh at ways to promote a competitive and sustainable market. 

In a wide-ranging interview with the Pink Sheet during last week’s Medicines for Europe biosimilars conference in Amsterdam, Adrian van...

More from Biosimilars

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.

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

 
• By Eliza Slawther

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

 
• By Sarah Karlin-Smith and Derrick Gingery

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 Vibha Sharma

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