FDA Approves Eighth Biosimilar, First for Cancer Drug Herceptin

Regulatory NewsRegulatory News | 01 December 2017 |  By 

The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche’s blockbuster breast and stomach cancer drug Herceptin (trastuzumab). Mylan and Biocon’s biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India.

First approved in the US in 1998, Herceptin had US sales of more than $2 billion for the 12 months ending 30 September 2017, according to IQVIA. In terms of the launch of the biosimilar, Mylan and Roche settled patent issues though the terms of that agreement are confidential, a Mylan spokesperson told Focus.

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+). Ogivri is the first biosimilar approved in the US for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the US for the treatment of cancer [the first was Amgen’s Mvasi (bevacizumab-awwb), approved in September as biosimilar to Roche’s cancer treatment Avastin (bevacizumab) though neither are interchangeable biosimilars].”

Manufacturing Issues

Both of the Avastin and Herceptin biosimilars won an FDA advisory panel’s unanimous backing in July, though manufacturing issues at Biocon’s Bengaluru, India-based facility were brought to light by French regulators from an inspection in March.

FDA then issued a Form 483 at the Bengaluru site and the target action date for FDA approval was pushed back to December, but Biocon and Mylan said the delay would not impact commercialization.

Meanwhile, in the EU, Mylan withdrew its application for the Herceptin biosimilar, though just yesterday, the companies said that the European Medicines Agency has since re-accepted its application.

Mylan and Biocon said its Herceptin biosimilar is also under review by regulators in Australia, Canada and others, and is already approved in 19 countries, including India. Other competitors to Herceptin are coming too. Last month, Roche sued Pfizer over its Herceptin biosimilar.


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