FDA News

FDA approves Ogivri, first biosimilar for certain breast, stomach cancers

The FDA today approved trastuzumab-dkst, the first biosimilar to treat patients with breast cancer or gastric or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER-2 gene.

Trastuzumab-dkst (Ogivri, Mylan GmbH) — a biosimilar to trastuzumab (Herceptin, Genentech) — is the second biosimilar approved in the U.S. for the treatment of cancer.

“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,” FDA Commissioner Scott Gottlieb, MD, said in a press release.

A biosimilar is a biological product — which is derived from a living organism such as humans, animals, microorganisms or yeast — that is approved based on data showing it is highly similar to an already-approved biological product. The biosimilar must show no clinically meaningful differences in safety, purity and potency from its reference product.

FDA based the approval of trastuzumab-dkst on a review of structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and clinical safety and efficacy that demonstrated its similarity with reference trastuzumab.

Common side effects associated with trastuzumab-dkst included headache, diarrhea, nausea, chills, fever, infection, weight loss, congestive heart failure, insomnia, neutropenia, anemia, stomatitis, upper respiratory tract infections, thrombocytopenia and mucosal inflammation. Serious adverse events include chemotherapy-induced neutropenia.

The FDA approved trastuzumab-dkst with a boxed warning regarding the increased risk for cardiomyopathy, infusions reactions, pulmonary toxicity and embryo-fetal toxicity.

The FDA today approved trastuzumab-dkst, the first biosimilar to treat patients with breast cancer or gastric or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER-2 gene.

Trastuzumab-dkst (Ogivri, Mylan GmbH) — a biosimilar to trastuzumab (Herceptin, Genentech) — is the second biosimilar approved in the U.S. for the treatment of cancer.

“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,” FDA Commissioner Scott Gottlieb, MD, said in a press release.

A biosimilar is a biological product — which is derived from a living organism such as humans, animals, microorganisms or yeast — that is approved based on data showing it is highly similar to an already-approved biological product. The biosimilar must show no clinically meaningful differences in safety, purity and potency from its reference product.

FDA based the approval of trastuzumab-dkst on a review of structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and clinical safety and efficacy that demonstrated its similarity with reference trastuzumab.

Common side effects associated with trastuzumab-dkst included headache, diarrhea, nausea, chills, fever, infection, weight loss, congestive heart failure, insomnia, neutropenia, anemia, stomatitis, upper respiratory tract infections, thrombocytopenia and mucosal inflammation. Serious adverse events include chemotherapy-induced neutropenia.

The FDA approved trastuzumab-dkst with a boxed warning regarding the increased risk for cardiomyopathy, infusions reactions, pulmonary toxicity and embryo-fetal toxicity.

    See more from Biosimilars in the United States: Current Status and Future Implications