MUMBAI, India and HERTFORDSHIRE, England and PITTSBURGH — Pharma major Lupin and Mylan announced that the two companies will partner to commercialize a biosimilar to Enbrel (etanercept). Through the partnership agreement, Mylan will commercialize Lupin’s proposed etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia.
Enbrel is a TNF-inhibitor indicated to treat certain autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Enbrel had global brand sales of approximately $11.6 billion for the 12 months ending Dec. 31, 2017, according to IQVIA.
Commenting on the development, Vinita Gupta, chief executive officer, Lupin Limited said, “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. Mylan is well-positioned to commercialize our Etanercept biosimilar given their significant expertise and global infrastructure. This partnership enables us to accelerate our Etanercept market plans across multiple regions globally, as we continue to advance our pipeline of biosimilar candidates.”
Mylan president Rajiv Malik commented, “The collaboration with Lupin is yet another positive step in our ongoing efforts to bring key biosimilars, like etanercept, to patients around the world as quickly as possible. 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 savings. We look forward to working closely with Lupin to commercialize their etanercept biosimilar and reach patients in Europe, Australia, New Zealand, Latin America, Africa and most Asian markets.”
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.