Mylan NV (NASDAQ:MYL) and Genetech, a Roche Holding AG unit, have reached a settlement regarding Herceptin, a therapy for some kinds of breast cancers. This will now allow Mylan global licenses for trastuzumab. Virtually all countries around the world will be covered by the licenses except for Mexico, Brazil and Japan. It is, however, not clear when the marketing of trastuzumab will start as the dates have been kept under wraps.
“The global license will provide a clear pathway for Mylan to commercialize its trastuzumab product in various markets around the world,” said Mylan in a press release.
The settlement will see Mylan withdraw the challenges it has filed to two patents held by Genentech in the United States. Herceptin is a blockbuster drug for Genentech as it brought in sales valued at $6.7 billion in 2016.
Earlier in January, the Food and Drug Administration accepted a license application from Mylan in which it had proposed a trastuzumab biosimilar, the MYL-14010. If MYL-14010 gets the approval of the Food and Drug Administration, it will be the pioneering trastuzumab in the United States. Currently, Biocon Ltd and Mylan have six biologic products that they have co-developed for markets around the world including New Zealand, Australia, Japan, Canada, and the U.S.
At present, the pharmaceutical company which is headquartered in Canonsburg, Pennsylvania sells the trastuzumab products in approximately 14 emerging markets. A couple of submissions are also pending in the EU and a number of other emerging markets.
In terms of volume, Mylan is the biggest supplier of cancer drugs in the United States. Mylan also recently launched Exemestane, a generic version of Aromasin that is manufactured by Pfizer Inc. (NYSE:PFE). The pharmaceutical firm boasts of having marketed products numbering around 7,500 across the globe. Besides cancer drugs, other products include antiretroviral therapies which are used by around half of the global population that is suffering from HIV/AIDS. Mylan has a presence in over 165 territories and countries.
On Tuesday shares of Mylan N.V. fell by 0.49% to close the day at $42.77 a share.