Monday, May 19, 2014

Boehringer-Ingelheim takes adalimumab biosimilar into Phase 3 development for RA

  • Boehringer has announced that a global Phase 3 study of BI 695501 will  open this month
  • The study will compare BI 695501 to US-sourced Humira in 600 patients with active rheumatoid arthritis
  • Primary endpoints, DAS28 and ACR20 at 24wks are expected to read out Sept 2015
  • Secondary endpoints include all-important immunogenicity at 24wks.  The study is expected to complete May 2016 with additional 48-48wk safety and efficacy endpoints
Comments: This is the third adalimumab biosimilar to enter Phase 3.  Sandoz advanced GP2017 for psoriasis Dec 2013.   Amgen is developing ABP 501 for both RA and psoriasis.  The latter is expected to complete March 2016, while the RA study opened Oct 2013 and is due to read out April 2015, one year before the Boehringer study is set to complete.  Of note, the Boehringer study has co-primary endpoints while Amgen is reporting just ACR20 as a primary end-point.  The Boehringer study study also has 100 more patients.  The full impact of the subtleties of Boehringer's study (ie US sourced Humira; co-primary end-point; time frame and study size) will be evaluated in the context of the FDA's recent draft guidance on biosimilars in our next issues of UpdatesPlus (RA, Psoriasis and IBD)

To view a recent issue of UpdatesPlus-Rheumatoid Arthritis click here - for subscription information please contact: fiona.watts(at)leaddiscovery(dot)co(dot)uk


Post a Comment

<< Home