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