Mylan, Biocon's Ogivri enters US market as first biosimilar of Roche's Herceptin not at legal risk

Mylan and partner Biocon on Monday announced the US launch of Ogivri (trastuzumab-dkst), a biosimilar referencing Roche's Herceptin, for all indications covered by Roche's drug, including HER2-overexpressing breast cancer and metastatic stomach cancer. Mylan president Rajiv Malik noted that "our early settlement and license with Roche to bring this product to market allows us to launch Ogivri without legal risk." 

Ogivri, formerly known as MYL-1401O, became the first Herceptin biosimilar approved in the US when regulators cleared the product in 2017 based on results from the Phase III HERITAGE trial. The settlement and licensing agreement with Roche gives Mylan exclusive marketing rights for Ogivri in the US, Canada, Japan, Australia, New Zealand and in Europe, while Biocon has co-exclusive rights with Mylan for the product in the rest of the world. 

Amgen and Allergan's Kanjinti (trastuzumab-anns) was approved by the FDA this past June and launched about a month later, making it the first Herceptin biosimilar that was available on the US market. At the time, the companies said Kanjinti would be roughly $3697 per 420 mg multi-dose vial, a 13% lower average selling price compared with Herceptin. Roche has filed motions to temporarily block Amgen from selling Kanjinti while its ongoing patent dispute makes its way through the legal system, but these were recently denied in US federal court and later on appeal. 

Meanwhile, Mylan and Biocon have noted that two supplemental applications were recently approved by the FDA to expand manufacturing capabilities for Ogivri, as well as for their first US biosimilar, Fulphila (pegfilgrastim-jmdb), which references Amgen's Neulasta. The companies said they have "sufficient manufacturing capacity to fulfil demand in the US and global markets for both products."

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