Mylan’s Ogivri becomes first and only FDA-approved Herceptin biosimilar
The FDA has announced the approval of Mylan’s Ogivri (trastuzumab-dkst), the first biosimilar version of Roche’s Herceptin to be authorised for use in the US and the second therapy of this kind for cancer after Amgen’s Mvasi earlier this year. The drug is approved for use in patients with HER2-positive4 breast and metastatic stomach cancers – the same indications as its reference product.
The decision was based upon assessment which found Ogivri to be “highly similar” to Herceptin, with “no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency.”
Ogivri was developed as part of a partnership with Biocon signed in 2009. Formerly known as MYL-1491O, the drug will be looking to cut into the market share occupied by Herceptin, which generated $6.7 billion for Roche in 2016.
“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients,” remarked FDA commissioner Scott Gottlieb.
Ogivri also secured authorisation in India in 2014 as well as 18 other countries, but it is still awaiting approval in a number of markets, including Europe, Australia and Canada.
Mylan CEO Heather Bresch also commented: “The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the U.S. healthcare system. It will allow us to bring this important biosimilar – the first of its kind – to market in the US, expanding cancer-patient access to more affordable treatment.”
Novartis has announced that the US Food and Drug Administration has approved Fabhalta (iptacopan) as …
Roche has announced that it has entered into a definitive merger agreement with Carmot Therapeutics, …