Published: Mon, December 04, 2017
Health | By Jay Jacobs

FDA Okays First Biosimilar For Treatment Of Certain Breast And Stomach Cancers

FDA Okays First Biosimilar For Treatment Of Certain Breast And Stomach Cancers

The US Food and Drug Administration had on Friday approved Mylan NV's biosimilar of Roche's blockbuster treatment for breast cancer, Herceptin, making it the second copycat cancer drug to be approved in the United States.

The biosimilar - developed by Mylan and Biocon and called Ogivri (trastuzumab-dkst) - has been approved by the FDA for HER2-positive breast or metastatic stomach cancer, the same indications as Herceptin which brought in nearly $7bn in sales previous year, around $2.5bn of that total from the U.S. market.

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+)". A biosimilar is a product, derived from a living organism, that is highly similar to a product already approved by the FDA with no meaningful difference in safety, purity or potency.

Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon's joint portfolio approved in the US.

Shares of Biocon hit a record high on US FDA approval for generic cancer drug Ogivri.

Biocon was the pick of the week as the company's partner Mylan got the US FDA's approval to market cancer biosimilar Trastuzumab in the US market.

In the USA, an estimated 250,000 new cases of female breast cancer and 28,000 new cases of stomach cancer are expected to be diagnosed in 2017 alone.

This is the eighth biosimilar approved by the FDA in quick succession as the agency tries to take action on high drug prices in the USA, and the second for a cancer antibody after Amgen and Allergan got a green light for their Mvasi biosimilar of Roche's Avastin (bevacizumab) in September.

Like this: