New Biosimilar Gets Green Light

Ogivri (trastuzumab-dkst) approved to treat breast and stomach cancers

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new biosimilar.

And it's the first biosimilar to treat certain breast and stomach cancers. It can be found under the brand name Ogivri, with the active ingredient trastuzumab-dkst.

This new medication has been approved to treat those with breast or advanced stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+).

According to the FDA, a biosimilar is a biological product that is highly similar to another biological product that has already been approved. This already approved product is known as a reference product. And in this case, the reference product is Herceptin (trastuzumab).

Ogivri's approval is based on extensive evidence that shows Ogivri is biosimilar to Herceptin, according to the FDA.

Common side effects of this medication may include headache, nausea, diarrhea, fever, infection and changes in blood cell counts. This medication may cause serious side effects like worsening neutropenia, which is a low level of certain white blood cells that results from chemotherapy.

Like its reference product, Ogivri comes with a boxed warning that includes the risks of heart disease, infusion reactions, lung damage and harm to a developing fetus. Speak to your health care provider about the best treatment option for you.

The FDA granted this medication's approval to Mylan GmbH.