Lupin & Mylan announce CHMP opinion for Nepexto

Lupin Limited and Mylan NV (NASDAQ: MYL) announced that European Medicines Agency's committee for medicinal products for human use (CHMP) has adopted a positive opinion recommending the approval of Nepexto, a biosimilar to Enbrel (etanercept), for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis.

The positive CHMP opinion is based on a bio-similarity assessment, which included preclinical and clinical studies demonstrating bioequivalence to the reference product. In addition, phase three clinical study in patients with moderate-to-severe active rheumatoid arthritis confirmed equivalence of Nepexto to the reference product in terms of efficacy, safety and immunogenicity.

The CHMP positive opinion will now be considered by European Commission (EC). Once approved, EC will grant centralised marketing authorisation for EU member countries . The decision on EC’s approval is expected by May 2020.

Enbrel had sales of approximately US$ 9.6 billion globally for tweleve-months ending December 2019, according to IMS Health (IQVIA).

Lupin Limited manufactures bulk actives and formulations. The principal bulk actives manufactured by it includes Rifampicin, Pyrazinamide, Ethambutol (anti-TB), Cephalosporins (anti-infectives) and cardiovasculars.

On Friday, the stock closed at Rs 547, down by two per cent or Rs 11.15 per share. The 52-week high was recorded at Rs 882.15 and the 52-week low was Rs 505 on BSE.