Lupin Partners With Mylan on Etanercept Biosimilar

Lupin recently announced that it has entered into a partnership agreement with Mylan to commercialize its proposed etanercept (Enbrel) biosimilar. The agreement authorizes Mylan to market the potential biosimilar in Europe, Australia, New Zealand, Latin America, Africa, and Asia.

Etanercept is an anti—tumor necrosis factor (TNF) inhibitor indicated to treat rheumatoid arthritis (RA), plaque psoriasis, ankylosing spondylitis, and other autoimmune diseases. Enbrel generated $5.2 million in sales in the United States in 2017.

Vinita Gupta, CEO of Lupin commented on the collaboration, stating, “We are extremely pleased to announce this partnership as both Lupin and Mylan share a commitment to bring affordable and high-quality medicines to market, especially in areas of unmet need.”

This is the second arrangement that Mylan has developed with a pharmaceutical company to accelerate a biosimilar commercialization. In April 2018, Mylan entered a partnership with Fijifilm Kyowa Kirin Biologics to launch its adalimumab biosimilar, referencing Humira, in Europe.

“The introduction of biosimilars is an important mechanism to help increase access to more affordable biologics treatments, and our industry-leading portfolio of 20 biosimilar products positions Mylan to be at the forefront of delivering those sales,” said Rajiv Malik, president of Mylan of the collaboration.

The proposed etanercept biosimilar completed a phase 3 clinical trial in February 2018 with a successful outcome. The 52-week trial, which included more than 500 patients with RA in 11 countries, compared the efficacy and safety of the proposed biosimilar directly with the reference product.

Under the terms of the agreement, Lupin will receive an upfront payment of $15 million as well as an equal share in net profits of the product. The potential biosimilar has been filed with the European Medicines Agency and Japanese regulatory authorities, and is planned to be filed in other domains.