Coherus Hoping For Expedited FDA Review Of Pegfilgrastim On-Body

Biosimilar Humira Sales Won’t Accelerate Until 2025; Pleased With Ranibizumab Execution

Coherus BioSciences offered clarity and insight into its three marketed biosimilar products, as the firm continues to await USFDA approval for its pegfilgrastim biosimilar using an on-body injector device.

Clocks
• Source: Shutterstock: elwynn

“Given there is not any new information to review,” Coherus BioSciences continues to anticipate approval from the “resource-constrained” US Food and Drug Administration for the company’s version of Amgen’s Neulasta (pegfilgrastim) Onpro on-body injector device using Coherus’ Udenyca (pegfilgrastim-cbqv) biosimilar “this year or in the early part of 2024.”

While pivoting towards a more novel biologics strategy, Coherus’ plotted return to growth for Udenyca is important in the next couple of years given that the firm concedes it will not see significant growth for its adalimumab biosimilar,

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

More from Products

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.