Mylan Partners with Lupin to Commercialize Arthritis Biosimilar



Mylan–Lupin commercialization partnership

Today, Mylan (MYL) and Lupin announced that the two companies have entered into a partnership for the commercialization of a biosimilar of Amgen’s (AMGN) Enbrel (etanercept). As per the agreement, Mylan will sell Lupin’s proposed biosimilar of Enbrel in EuropeLatin AmericaAustraliaNew ZealandAfrica, and most Asian markets. The slide below shows Mylan’s biosimilar pipeline.

Enbrel is a TNF (tumor necrosis factor) inhibitor used for autoimmune diseases including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and ankylosing spondylitis. Enbrel is one of the larges-selling pharmaceutical products in the world, and it registered global brand sales of ~$11.6 billion in 2017.

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Lupin’s biosimilar version of Enbrel

Lupin completed the Phase 3 trial for its Enbrel biosimilar in February and has already filed the product for approval in Europe. The company has yet to apply for the approval of the drug in other markets.

As per IQVIA, outside the United States, Etanercept is estimated to have a market size of $4 billion, which includes Japan, Europe, emerging markets, and other regulated markets.

Financial terms of the agreement

As per the partnership agreement, Lupin will get an upfront payment of $15 million and additional commercial milestone–based payments. Also, both companies are to equally share the net profits of the product sale.

According to Rajiv Malik, president of Mylan, “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.”

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