Polpharma Celebrates Being First With Natalizumab In Europe

Proposed Biosimilar Rival To Tysabri Begins EMA Review; Sandoz Has Marketing Rights

Polpharma Biologics has claimed the first biosimilar natalizumab filing in Europe, after the European Medicines Agency accepted the firm’s marketing authorization application for review.

EU flag medal 1st first place
Polpharma has claimed the first biosimilar natalizumab filing • Source: Shutterstock

Polpharma Biologics says it has successfully filed the first natalizumab biosimilar in Europe, announcing that the European Medicines Agency has accepted the firm’s marketing authorization application for review.

Representing a rival to Biogen’s relapsing-remitting multiple sclerosis therapy Tysabri, the intravenous biosimilar offers “the same dosing regimen,

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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

Cutting Out The Middlemen? Trump’s Pricing Order Offers Opportunity On PBMs

 
• By 

Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.

Amneal Proud To Be ‘Made In America’ And Ready To Scale Up Its US Manufacturing

 

Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.

‘I’ll Be Happy When We Have 40-Plus Assets’ – Sandoz Builds Up Biosimilars

 
• By 

With biosimilars playing an increasingly important role in Sandoz’s business, the firm’s first-quarter results call saw management lay out the latest key developments. Meanwhile, the company also addressed the issue of US tariffs, voicing optimism over both future developments as well as its ability to weather current measures.

Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense’ Transfer To mAbxience Continues

 
• By 

Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.

More from Products

Amneal Proud To Be ‘Made In America’ And Ready To Scale Up Its US Manufacturing

 

Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.

‘I’ll Be Happy When We Have 40-Plus Assets’ – Sandoz Builds Up Biosimilars

 
• By 

With biosimilars playing an increasingly important role in Sandoz’s business, the firm’s first-quarter results call saw management lay out the latest key developments. Meanwhile, the company also addressed the issue of US tariffs, voicing optimism over both future developments as well as its ability to weather current measures.

Tetris Deal Falls Into Place For UK’s Aspire

 
• By 

Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.