CHMP Positive On Pfizer's Adalimumab

As Accord Gets Nods For Azacitidine And Dexmedetomidine

Pfizer’s Amsparity biosimilar adalimumab has been endorsed by the EMA’s CHMP as a rival to Humira. At the same time, Accord has received positive opinions for generic azacitidine and dexmedetomidine.

Pfizer
Pfizer has received a CHMP nod for its Amsparity full-label adalimumab biosimilar rival to Humira • Source: Shutterstock

Pfizer has received a positive opinion for its Amsparity (adalimumab) biosimilar version of AbbVie’s Humira from the European Medicines Agency’s Committee for Medicinal Products for Human Use, recommending granting a pan-European marketing authorization.

The European Commission, which is responsible for issuing final centralized marketing authorizations, typically acts on CHMP positive opinions within 67...

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

Polpharma Biologics And Fresenius Kabi Team Up On Entyvio Biosimilar

 

Fresenius Kabi has picked up commercialization rights to Polpharma Biologics’ vedolizumab biosimilars in almost all markets. Still, the originator Takeda stands solid with no competition expected until at least 2032.

Celltrion And Arrotex Tie Up For A Pair Of First PBS-Listed Australian Biosimilars

 
• By 

Arrotex has entered into a strategic partnership with Celltrion Healthcare Australia to launch two first-to-market biosimilar medicines in Australia. These biosimilars, which treat chronic inflammatory conditions, are now listed on the PBS and available through pharmacies.

Cipla Revs Up Biosimilars Engine Amid Winds Of Regulatory Change

 

Cipla’s partnered filgrastim biosimilar is expected to debut in the US in Q2 FY26 and the Indian firm expects an investment return ratio for its biosimilar engine “not too far” from that of a complex generic product amid an enabling regulatory environment.

Samsung Bioepis’ Second Quarter Comes Down From Milestone-Boosted Q2 2024

 

With the looming spin-off on the horizon, Samsung Bioepis looks at planned product launches and geographic expansion to maintain its annual revenue growth.

More from Products

Sandoz Rushes To Fill Gap After German Court Revokes Xarelto Patent

 
• By 

Germany’s Federal Patent Court has invalidated Bayer’s key patent covering once-daily use of Xarelto (rivaroxaban), paving the way for Sandoz to launch a generic version. Bayer is considering an appeal.

Samsung Bioepis’ Second Quarter Comes Down From Milestone-Boosted Q2 2024

 

With the looming spin-off on the horizon, Samsung Bioepis looks at planned product launches and geographic expansion to maintain its annual revenue growth.

Medicines UK’s Samuels: Off-Patent Drugs Are Finally Gov’s Priority But The Picture Still ‘Nuanced’

 

The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. But, as Medicines UK’s CEO Mark Samuels tells Generics Bulletin, companies are still facing multiple hurdles in the market.