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Rheumatoid Arthritis : Update Bulletin [December 2016]

Product Code:
Publication Date:
December 2016

Gain new KOL insights on the latest events happening in rheumatoid arthritis (RA). During September 2016, the US FDA approved Amgen's Amjevita (adalimumab-atto), as a biosimilar to AbbVie's Humira for multiple inflammatory diseases, including RA. In September 2016, Gilead Sciences initiated a Phase II trial to evaluate the safety, tolerability, and efficacy of GS 9876, a Syk kinase inhibitor, in patients with active RA on background therapy with methotrexate. In October 2016, Sanofi and Regeneron announced that the US FDA issued a complete response letter regarding their application for the investigational IL-6R antibody, sarilumab.

Key business questions

  • What are the reactions from KOLs regarding the FDA approval of the first Humira biosimilar, Amjevita? 
  • In a biosimilar market that looks set to grow, which factors will influence their uptake and what are KOLs’ views on switching between biosimilars?
  • To what extent are KOLs concerned by “certain deficiencies” found at Sanofi’s Le Trait facility in which sarilumab is filled and finished?
  • How does sarilumab compare with Actemra/RoActemra and where in the treatment paradigm would such an agent be positioned?
  • How do KOLs react to the development of another Syk inhibitor, GS 9876?
  • Where in the treatment paradigm do KOLs expect GS 9876 to be used and which other MOAs will be of interest going forward?


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