Mylan Rolls out Herceptin Biosimilar in India

Zacks

Mylan Inc. (MYL), one of the leading players in the global generics market, has been focusing on high potential emerging markets like India to drive growth. Emerging markets are slowly and steadily gaining more importance and several companies are now shifting their focus to these areas.

A prevalent phenomenon in the medical sector is the shift in focus of several companies on the highly lucrative biosimilars (generic versions of biologics) market. Biosimilars are expected to be a significant growth driver in the generics industry in the coming years. The biosimilars market represents huge commercial opportunity with a significant amount of biologic sales slated to lose patent protection in the coming years.

Mylan entered the biologics space by striking a partnership with India-based Biocon Ltd in 2009. In Feb 2013, Mylan extended its partnership with Biocon. In an encouraging development related to biosimilars, Mylan announced the launch of its biosimilar version of Roche's (RHHBY) breast cancer drug Herceptin (trastuzumab) in India under the trade name Hertraz. The drug will be sold under the dosages 440 mg and 150 mg. This is the first time that a Herceptin biosimilar has been launched anywhere in the globe. We remind investors that the Drug Controller General of India cleared the biosimilar in November last year.

We note that Mylan possesses exclusive commercialization rights for the biosimilar of the breast cancer drug in the U.S., Canada, Japan, Australia, New Zealand and in the EU and European Free Trade Association countries. In India, Mylan has co-exclusive rights with Biocon to market the drug.

In other development related to India and Mylan, it was chosen as the exclusive branded medicines partner by biopharmaceutical company Gilead Sciences, Inc. (GILD) in the country. Following the deal, Mylan is responsible for selling Gilead’s key HIV drugs like Truvada and Stribild. Mylan will also market Gilead’s Viread (HIV as well as chronic hepatitis B virus infection) in India following the agreement. Gilead’s AmBisome will also be marketed in India by Mylan going forward. The deal represents an extension of the agreement inked by the companies in 2006. The 2006 deal granted Mylan rights to manufacture and sell its generic versions of Gilead’s licensed HIV treatments in up to 111 developing nations (including India) where the disease is highly prevalent.

Mylan carries a Zacks Rank #3 (Hold). A better-ranked stock in the generic space is Actavis (ACT) with a Zacks Rank #1 (Strong Buy).

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