1. Generics Bulletin
  2. >>Products

Coherus Eyeing US Pegfilgrastim Bulk With On-Body Injector Approval

Amgen’s Onpro Version Commands the >40% Of The US Market

 
• By Dean Rudge

Coherus has roared into the new year with a US FDA approval that has long been on its radar: the company’s debut rival to the Neulasta Onpro on-body injector device using Coherus’ Udenyca (pegfilgrastim-cbqv) biosimilar.

Complete Word Jigsaw Pieces
• Source: Cagkan Sayin / Alamy Stock Photo

Coherus BioSciences is set to become the first company to offer biosimilars to Amgen’s complete range of Neulasta (pegfilgrastim) products, after obtaining approval from the US Food and Drug Administration for the company’s version of the Neulasta Onpro on-body injector device using Coherus’ Udenyca (pegfilgrastim-cbqv) 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
Start Free Trial

Already a subscriber?

More from Products

OGD’s Policy Office Cut To Have ‘Profound’ Impact On New Generic Approvals, Warns Former FDA Head Gottlieb

 
• By Urtė Fultinavičiūtė

The elimination of the policy division at the Office of Generic Drugs, tariffs, the Section 232 investigation, and a new executive order to promote lower drug prices seem to both cause and purport to solve the same problem: supply chain disruption.

Sunshine Becomes Latest To Compete On Everolimus In Canada

 
• By Dave Wallace

Sunshine Biopharma is continuing to roll out generic launches in Canada, with its latest product challenging Afinitor and other everolimus rivals in the market.

Celltrion Celebrates Interchangeability Designation For Humira Biosimilar In The US

 
• By Urtė Fultinavičiūtė

Celltrion’s adalimumab biosimilar was crowned as interchangeable by the FDA, at a time when the future of the designation is unknown.

Samsung Bioepis Reevaluating Approach To Biosimilars

 
• By Jessica Merrill

The challenging US biosimilar market remains a persistent problem, leading the biosimilar developer to reconsider how it invests in the future while pushing for changes.

More from Generics Bulletin

Xbrane Approves Deal Giving Away Cimzia Rival To Alvotech

 
• By Adam Zamecnik

After announcing the agreement last month, Xbrane has now approved its deal with Alvotech as part of an extra general meeting.

Celltrion Celebrates Interchangeability Designation For Humira Biosimilar In The US

 
• By Urtė Fultinavičiūtė

Celltrion’s adalimumab biosimilar was crowned as interchangeable by the FDA, at a time when the future of the designation is unknown.

Samsung Bioepis Reevaluating Approach To Biosimilars

 
• By Jessica Merrill

The challenging US biosimilar market remains a persistent problem, leading the biosimilar developer to reconsider how it invests in the future while pushing for changes.