FDA Approves Mylan’s Herceptin Biosimilar
The US Food and Drug Administration (FDA) has given the green light to Netherlands-domiciled, US-managed generic drugmaker Mylan’s Ogivri (trastuzumab-dkst) breast cancer drug, a biosimilar to the Roche blockbuster Herceptin (trastuzumab).
Ogivri, co-developed with India’s Biocon, is the first Herceptin biosimilar to be approved for the US market and was greenlighted for all indications included in the label of the reference product, including HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).
The drug is also the first biosimilar from Mylan and Biocon's joint portfolio to be approved in the US. Mylan secured secure global licenses for its trastuzumab product from drug developer Genentech – which belongs to Roche – earlier this year.
Roche’s Herceptin had US sales of more than $2 billion in fiscal 2017, which ended Sept. 30.
The Swiss pharmaceutical group is seeking to block another Herceptin biosimilar made by US drugs giant Pfizer, which is not yet FDA-approved.
Mylan regards itself as a global leader in the development and manufacturing of complex drugs, with a portfolio of 16 biosimilar and insulin analog orproducts. CEO Heather Bresch said Ogivri will expand access to the treatment and make it me affordable.
The FDA's go-ahead for the biosimilar follows a unanimous recommendation by its Oncologic Drugs Advisory Committee (ODAC) in July of this year. The new drug has now been approved for use in 19 countries, including India, and is said to be under review by regulatory authorities in Australia, Canada, Europe and several additional markets.
According to reports, an estimated 250,000 new cases of female breast cancer and 28,000 new cases of stomach cancer were projected to be diagnosed in the US during 2017. Statistically, some 20-25% of primary breast cancers are HER2-positive.
