Lupin Ltd. and Mylan N.V. both issued press releases today announcing a collaboration to commercialize a biosimilar to Amgen’s Enbrel® (etanercept).  Mylan will commercialize Lupin’s proposed etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia.

According to the press releases, Lupin successfully completed its Etanercept biosimilar Phase 3 clinical trial in February 2018. Lupin has filed the product with the European Medicines Agency and plans to file the product in other jurisdictions.  Under the terms of the agreement, Lupin will receive an up-front payment of $15 million and potential commercial milestones together with an equal share in net profits of the product.

In connection with the Lupin and Mylan announcement, Biocon, which also has a collaboration agreement with Mylan regarding numerous biosimilars including etanercept, stated today: “Biocon clarifies that it retains its economic interest in this arrangement vis-à-vis Mylan in accordance with its existing collaboration agreement and would benefit from the opportunity to accelerate commercialization of this product.”