Mylan and Lupin Receive EC’s MAA for Nepexto (biosimilar, etanercept)

Shots:

• The EC has granted MAA for Nepexto, a biosimilar referencing Enbrel (etanercept), for all indications of the reference product including RA, JIA, PsA, axSpA (including axSpA and nr-axSpA), plaque psoriasis and pediatric plaque psoriasis
• The EC’s approval follows the CHMP’s positive opinion which is based on a biosimilarity assessment including preclinical and clinical studies demonstrating bioequivalence to Enbrel
• The P-III study demonstrated confirmed equivalence of Nepexto to Enbrel in terms of efficacy, safety and immunogenicity in patients with P-III study with moderate-to-severe active RA. The companies anticipates the launch of Nepexto in H2’20

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Lupin