Lupin recently announced that it has entered into a partnership agreement with Mylan to commercialize its proposed etanercept (Enbrel) 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.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Coherus Biosciences Cites Biosimilars as Main Drivers of 2023 Revenue Growth
March 14th 2024In its earnings report for the fourth quarter and full year of 2023, Coherus Biosciences detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
Eye on Pharma: Canadian Aflibercept Settlement; Sandoz Acquires Cimerli; Payer Chooses Cyltezo
March 6th 2024Biocon Biologics settled with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.