LONDON, Dec 1 (APM) - Mylan and Biocon’s biosimilar of Roche’s best-selling breast cancer drug Herceptin (trastuzumab) has become the first approved in the States, the U.S. Food and Drug Administration (FDA) said on Friday.
The biologic copy - known as Ogivri - was approved for HER2+ breast cancer and metastatic stomach cancers (gastric or gastroesophageal junction adenocarcinoma), the FDA said in its Friday statement.
Approval of the biologic copy follows shortly after the FDA confirmed that issues at Biocon’s manufacturing facilities in India used in the market application had been cleared (APMMA 55704). Issues at the Bengaluru plan were cited as the FDA’s reason for delaying its approval decision by three months, in late August (APMMA 54473).
The regulator’s Friday approval comes two days before its December 3 deadline.
Beside being the first Herceptin biosimilar to be approved in the U.S., “Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer,” the FDA said.
Commissioner Scott Gottlieb said the FDA is committed to taking new policy steps to advance more biosimilars and promote competition on biologic drugs, adding: “This is especially important when it comes to diseases like cancer, that have a high cost burden for patients”.
Samsung Bioepis, a joint venture between Biogen and Samsung BioLogics, also has a version of Herceptin approved in Europe (APMMA 55674) and in South Korea (APMMA 55545).
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