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

 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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