The US FDA will Approve a New Pathway for Biosimilars

  • The EMA’s CHMP has adopted a positive opinion recommending the approval of Nepexto, a biosimilar referencing Enbrel (etanercept), for all indications of the reference product including RA, JIA, PsA, axSpA (including AS and nr-axSpA), PsO and pediatric PsO
  • The positive opinion is based on biosimilarity assessment which included pre/ clinical studies demonstrating bioequivalence to the reference product. Additionally, the P-III clinical study demonstrated the equivalence of Nepexto to the Enbrel in patients with mod. to sev. RA
  • The EC will review the CHMP’s positive opinion with its anticipated approval in May’2020. In Jun’2018, the companies collaborated to commercialize Nepexton in multiple global markets

Click here to read full press release/ article | Ref: The US FDA | Image: Twitter