Monday, 26 August, 2019


FDA approves Ogivri, first biosimilar for treating breast and stomach cancers

Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products
Patty Aguilar | 02 December, 2017, 01:16

The Food and Drug Administration (FDA) has approved Ogivri (trastuzumab-dkst; Mylan), a biosimilar to Herceptin (trastuzumab; Genentech), for the treatment of HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.

The maker of a biosimilar, derived from a living organism, must demonstrate that the new product is "highly similar" to an already approved medication, and that it has no clinically significant difference in terms of its potency, safety and purity, the FDA said.

"The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower healthcare costs", FDA Commissioner Scott Gottlieb, MD, said in a statement.

The newly approved drug, made by Mylan, will go by the marketed name Ogivri. "We're committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs".

Supporting evidence included data from a single clinical trial comparing the biosimilar to branded trastuzumab approved for use in Europe (EU-trastuzumab).

As it stands right now, biosimilars can't be used interchangeably with branded versions, meaning if you were to get a prescription for a branded biologic, you wouldn't be able to opt for the "generic" one at the pharmacy as easily as you could if the drug was an antibiotic.

The FDA granted a first-ever approval on Friday for a biosimilar for the HER2 receptor inhibitor trastuzumab (Herceptin).

First approved in the U.S. in 1998, Herceptin had United States sales of more than $2 billion for the 12 months ending 30 September 2017, according to IQVIA.

"This approval represents a landmark achievement for the Biocon-Mylan collaboration and is an important endorsement of our development and manufacturing capabilities in the area of monoclonal antibodies", said Arun Chandavarkar, chief executive officer and joint managing director of Biocon.

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