Mylan and Lupin Receive CHMP’s Positive Opinion for Nepexton (biosimilar, etanercept)

Mylan and Lupin Receive CHMP’s Positive Opinion for Nepexton (biosimilar, etanercept)

Shots:

  • 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 bio similarity 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: Mylan | Image: GMP News