1. Pink Sheet
  2. >>Legal & IP

Pfizer's Remicade Biosimilar: Sept. 15 Is Earliest Launch Date

 
• By Brenda Sandburg

Pfizer and Celltrion agreed not to market Inflectra, their biosimilar to Janssen's blockbuster TNF-inhibitor, before mid-September barring certain circumstances.

Janssen Biotech Inc. has succeeded in pushing back the earliest launch date for Pfizer Inc.'s biosimilar to Remicade (infliximab), though it may still come sooner than Janssen wishes.

Celltrion Inc. and US marketing partner Pfizer previously agreed not to launch Inflectra (infliximab-dyyb) in the US before June...

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
Start Free Trial

Already a subscriber?

More from Legal & IP

More from Pink Sheet

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

Global Pharma Guidance Tracker - June 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.