Ogivri (trastuzumab-dkst) is the first US Food and Drug Administration (FDA)-approved biosimilar of Roche and Genetech’s Herceptin, which Mylan said secured a “clear pathway” to commercialise the biosimilar in various markets globally.
“[This approval] will allow us to bring this important biosimilar – the first of its kind – to market in the US, expanding cancer-patient access to more affordable treatment,” said Mylan CEO Heather Bresch in a statement.
Mylan and Biocon’s biosimilar for Herceptin is under review by regulatory authorities in Australia, Canada, Europe, and several additional markets, a Mylan spokesperson Julie Kell told us.
“It is already approved in 19 countries around the world,” she added.
cGMP concerns
The approval decision comes several months later than expected after the FDA pushed back its action date by three months.
The FDA visited Biocon’s Plot 2-4 Phase IV facility in Bangalore, India in May, which resulted in a Form 483 citing 10 current good manufacturing practice (cGMP) deviations. However, Biocon said the delayed trastuzumab decision was not related to these concerns.
And on November 20, a Biocon spokesperson said the FDA had issued an establishment inspection report (EIR) following an audit at its aseptic drug product facility between May 25 and June 3.
“The FDA has classified the outcome of this inspection as VAI (“voluntary action indicated”) and the EIR states that the inspection is closed,” said the spokesperson in a statement.
The site was also inspected by France’s Agence National de Sécurité de Médicaments (ANSM), which raised a number of cGMP concerns.
Mylan and Biocon’s submission to the European Medicines Agency (EMA) for their Herceptin biosimilar was withdrawn following a site inspection by France’s ANSM in March, which cited 35 cGMP issues at Biocon’s fill and finish plant in Bangalore, India.
However, last week the firms said the EMA had accepted their submission to review the biosimilar version of Roche’s Herceptin.