• 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