First Biosimilar Approved for Breast, Stomach Cancers

Henrietta Strickland
December 2, 2017

The FDA on Friday approved a version of Herceptin, a blockbuster cancer drug used to treat breast and stomach cancer.

Both of the Avastin and Herceptin biosimilars won an FDA advisory panel's unanimous backing in July, though manufacturing issues at Biocon's Bengaluru, India-based facility were brought to light by French regulators from an inspection in March. "The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs".

Having more biosimilars in the United States would be a big deal: It might be the best way to drive down the cost of biologic medications that have been around for a while. Trastuzumab-dkst is also the second biosimilar approved for cancer.

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

The approval of Ogivri was based on data review of its structural and functional characterization, animal study, human pharmacokinetics/pharmacodynamics, clinical immunogenicity, and other clinical safety and efficacy data that showed Ogivri was biosimilar to Herceptin.

FDA said Ogivri is approved (here's the label) "for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+)".

Trastuzumab-dkst also comes with the Black Box Warnings of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity.

Mylan GmbH will market Ogivri. "Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan's ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year", Mylan said in a press release.

Other reports by Click Lancashire

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