Business EconomyPosted at: Jun 4 2020 6:27PM

Lupin and Mylan receive European marketing authorization for Nepexto

Mumbai , Jun 4 (UNI) Lupin Limited and Mylan NV on Thursday announced that the European Commission (EC) has granted marketing authorisation for Nepexto, a biosimilar to Enbrel (etanercept).
The EC has granted marketing authorisation for Nepexto for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis.
The regulatory approval follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in March this year, which was based on a biosimilarity assessment including preclinical and clinical studies demonstrating bioequivalence to Enbrel.
In addition, a phase 3 clinical study in patients with moderate-to-severe active rheumatoid arthritis confirmed equivalence of Nepexto to Enbrel in terms of efficacy, safety and immunogenicity, Lupin said in a filing with BSE.
The centralised marketing authorisation applies to all member countries of the European Union.
Vinita Gupta, CEO, Lupin Limited said, "We are truly delighted with this approval. Nepexto is our first biosimilar to receive regulatory approval in Europe. With this important milestone, we bring an affordable biosimilar to the European market through our partner Mylan. Biosimilars like Nepexto will play a critical role in expanding access to patients in Europe, providing an effective treatment for multiple therapies including rheumatoid arthritis."
Mylan President, Rajiv Malik commented, "The approval of Nepexto, our biosimilar etanercept, is a positive step forward as we work to broaden our biosimilars franchise offerings and do our part to increase access to biologic treatments for patients in many European countries. This milestone reflects a strong scientific program behind Nepexto and commitment by our teams and our partner, Lupin, to bring the product to market as soon as possible. We look forward to launching Nepexto in the second half of this year."
Enbrel had sales of approximately 9.6 billion dollars globally for the 12 months ending December 2019, according to IQVIA.
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India International Industrial Expo in Kochi from Dec 13-15, 2024

19 Apr 2024 | 12:56 PM

Kochi, Apr 19 (UNI) India International Industrial Expo (IIIE-2024), a gateway to a comprehensive industrial showcase, will be held here on December 13, 14 and 15, 2024 with the participation of more than 10,000 trade visitors and 350 leading Industrial manufacturers, IIIE CEO Siji Nair said on Friday.

Lupin and Mylan receive European marketing authorization for Nepexto

India International Industrial Expo in Kochi from Dec 13-15, 2024

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AGARTALA, APR 19 (UNI):- Voters stand in a queue to cast their vote for the first phase of Lok Sabha elections, at a polling station in Agartala on Friday. UNI PHOTO-177U

PORT BLAIR, APR 19 (UNI):- Voters displaying identity cards while standing in the queue to cast their votes at a polling booth during the 1st Phase of General Elections-2024 at Govt. Primary School Mazar Pahad Port Blair, in Andaman and Nicobar Islands on Friday. UNI PHOTO-178U

PORT BLAIR, APR 19 (UNI):- Voters displaying identity cards while standing in the queue to cast their votes at a polling booth during the 1st Phase of General Elections-2024 at Govt. Primary School Mazar Pahad Port Blair, in Andaman and Nicobar Islands on Friday. UNI PHOTO-176U

GAYA, APR 19 (UNI):- Voters displaying identity cards while standing in the queue to cast their votes at a polling booth during the 1st Phase of General Elections-2024 at Samudaik Bhawan, village Ramsila, Gaya in Bihar on Friday. UNI PHOTO-172U

GAYA, APR 19 (UNI):- Voters displaying identity cards while standing in the queue to cast their votes at a polling booth during the 1st Phase of General Elections-2024 at Samudaik Bhawan, village Ramsila, Gaya in Bihar on Friday. UNI PHOTO-171U

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JOWAI, APR 19 (UNI):- Voters waiting in queue for their turn to cast vote for the Lok Sabha election during the first phase of Lok Sabha election at a polling centre in Jowai on Friday.UNI PHOTO-165U

JOWAI, APR 19 (UNI):- A woman voter shows her inked finger after casting vote for the Lok Sabha election during the first phase of Lok Sabha election at a polling centre in Jowai on Friday.UNI PHOTO-164u

JOWAI, APR 19 (UNI):- Voters waiting in queue for their turn to cast vote for the Lok Sabha election during the first phase of Lok Sabha election at a polling centre in Jowai on Friday.UNI PHOTO-163U

GAYA, APR 19 (UNI):- A voter casting her vote at a polling booth during the 1st Phase of General Elections-2024 at Gram panchayat, Khada Karbala Iqbal Nagar, Gaya in Bihar, on Friday. UNI PHOTO-158U

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JABALPUR, APR 19 (UNI):- Voters showing mark of indelible ink after casting their votes at a polling booth during the 1st Phase of General Elections-2024 at Wright Town, in Jabalpur, Madhya Pradesh on Friday. UNI PHOTO-151U

HYDERABAD, APR 19 (UNI):- BJP candidate from Secunderabad G Kishan Reddy along with party leaders on his way to file nomination papers for the upcoming Lok Sabha election, at Mehboob College, in Secunderabad on Friday. UNI PHOTO-147U

GUWAHATI, APR 19 (UNI):- BJP candidate for Guwahati Lok Sabha seat Bijuli Kalita Medhi with other party leaders on her way to file nomination papers for the upcoming Lok Sabha election, in Guwahti on Friday. UNI PHOTO-146U

GUWAHATI, APR 19 (UNI):- BJP candidate for Guwahati Lok Sabha seat Bijuli Kalita Medhi along with Assam chief minister Himanta Biswa Sarma and other party leaders at a public rally, at Khanapara on Friday. UNI PHOTO-145U