Date: 2018-06-18
Type of information: Commercialisation agreement
Compound: etanercept biosimilar
Company: Mylan (USA - PA) Lupin (India)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Dermatological diseases
Type agreement: commercialisation
Action mechanism:
- TNF alpha inhibitor/biosimilar. Etanercept (Enbrel®) is a competitive inhibitor of TNF, it binds to cell surface TNFR, preventing TNF mediated cellular responses by rendering TNF biologically inactive. Etanercept may also modulate biologic responses controlled by additional downstream molecules (cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF.
- Enbrel® had global brand sales of approximately $11.6 billion for the 12 months ending Dec. 31, 2017, according to IQVIA.
Disease: rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis
Details:
- • On June 28, 2018, 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.
- 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.
Financial terms:
- 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.
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Is general: Yes
