1. Generics Bulletin
  2. >>Products
  3. >>Generics

REMS Abuse Website: Celgene, Actelion Top List Of Suspected 'Gamers'

 
• By Michael Cipriano

Other sponsors could be using tactics other than REMS abuse to game the system, US FDA Commissioner Scott Gottlieb says.

Generic drug manufacturers appear to have had the most trouble obtaining access to samples from Celgene Corp. and Johnson & Johnson unit Actelion Pharmaceuticals Ltd., as the US FDA has released its list of inquiries and safety determination letters sent to brand companies in the agency's battle against misuse and abuse of risk evaluation and mitigation strategies (REMS) and other innovator gaming methods.

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 Generics

Regulatory Recap: UK To Capture £1bn Savings With Framework For Best-Value Biologics

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

Aurobindo Plots Rivaroxaban Roll-Out As FDA Approves 2.5mg Strength ANDA

 
• By Dean Rudge

Aurobindo is set to join Lupin by competing against Johnson/Bayer’s blockbuster blood thinner Xarelto (rivaroxaban) 2.5mg tablets.

Tevogen Launches Generics-Focused Initiative As Trump Eyes Pharma Tariffs

 
• By Adam Zamecnik

As the Trump Administration continues to send ripples across industries, Tevogen has launched a new generic drugs-focused endeavor that plans to reshore production to the US.

Sandoz Admits To Widescale Infringement In Resolving US Rinvoq Patent Tussle

 
• By Dean Rudge

Sandoz has reached an agreement with AbbVie to dismiss without prejudice patent-infringement litigation involving more than 20 patents shielding the originator’s blockbuster JAK inhibitor Rinvoq.

More from Products

Coherus Marks Exit From Biosimilars By Completing Udenyca Divestment

 
• By Dave Wallace

Coherus has officially marked its exit from biosimilars by completing the divestment of its Udenyca pegfilgrastim franchise. Meanwhile, buyer Accord BioPharma has set out how it expects to benefit not only from a growing asset but also from the Coherus personnel that have moved over.

Sandoz Admits To Widescale Infringement In Resolving US Rinvoq Patent Tussle

 
• By Dean Rudge

Sandoz has reached an agreement with AbbVie to dismiss without prejudice patent-infringement litigation involving more than 20 patents shielding the originator’s blockbuster JAK inhibitor Rinvoq.

Biocon Chooses To Settle Over Eylea In US – Will Others Follow?

 
• By Dave Wallace

After Amgen’s surprise launch of the first US biosimilar to Eylea last year, expectations around competition are being further upended with the news that Biocon Biologics has struck a settlement deal with Regeneron allowing it to launch its own aflibercept rival in the second half of 2026. Will other challengers follow suit?