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Mylan, Lupin Collaborate for the Proposed Biosimilar Enbrel

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Mylan N.V. (MYL - Free Report) and India-based Lupin Limited have entered into a partnership to commercialize a biosimilar of Amgen’s (AMGN - Free Report) blockbuster drug Enbrel (etanercept).

Per the partnership agreement, Mylan will commercialize Lupin's proposed biosimilar in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia.

We note Enbrel is approved to treat certain autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. According to IQVIA, brand sales of approximately $11.6 billion for the 12 months ending Dec. 31, 2017.

Lupin successfully completed its phase III trial, etanercept, in Feb 2018. The company has filed the product with the European Medicines Agency and plans to file the product in other jurisdictions.

Assuming approval, the biosimilar will have great market potential given the sales. Per the agreement, Lupin will receive an up-front payment of $15 million. The company is entitled to commercial milestones together with an equal share in net profits of the product.

Mylan has one of the widest portfolios of generics and biosimilars and the addition of a biosimilar of Enbrel will further boost the company’s portfolio. Mylan’s biosimilar portfolio got a boost with the recent FDA approval of Fulphila, a biosimilar of Neulasta. The company had earlier won FDA approval of Ogivri, a biosimilar of Roche’s (RHHBY - Free Report) Herceptin.

On the other hand, agreement with Mylan bodes well for Lupin given the former’s significant expertise and global infrastructure.


Mylan’s stock has lost 11.5% in the year so far compared with the industry's gain of 0.8%. The stock took a hit earlier in the month after the company announced that the FDA will not approve its Abbreviated New Drug Application for the generic version of GlaxoSmithKline’s (GSK - Free Report) asthma drug, Advair Diskus, yet again.

Mylan had received a major boost with the FDA approval for a generic version of Copaxone 40mg. The company has more than 30 submissions planned in 2018. However, the generic business in the United States continues to experience pricing pressure.  Although volatility in the markets is expected to continue in 2018, yet these new approvals should position Mylan better in the year ahead and help it combat the decline in EpiPen sales which is also facing supply constraint issues.

Zacks Rank

Mylan carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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