Amgen's Amjevita Approved As First Biosimilar To AbbVie's Humira

Adalimumab-atto is approved for seven indications on the reference product label but lacks four others that are protected by orphan product exclusivity; launch timing is unclear due 'patent dance' litigation.

With its fourth biosimilar approval, FDA has once again shown that its thinking about how to label such products continues to evolve.

In the case of Amgen Inc.'s Amjevita (adalimumab-atto), FDA took the opportunity to adjust its biosimilar labeling approach on indications for which the reference product sponsor still holds exclusivity.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Approvals

More from Product Reviews

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor

 

The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.