“Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan’s ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year,” Mylan said in a statement, referring to an earlier settlement with Roche over the same drug.
“This milestone secured a clear pathway to commercialize Mylan’s biosimilar to Herceptin in Various markets globally. It will allow us to bring this important biosimilar – the first of its kind-to market in the U.S., expanding cancer-patient access to more affordable treatment,” Mylan said.
Biocon has been keen to get its anti-cancer biosimilars — drugs that mimic natural proteins — approved in key markets of US and Europe. It applied for approval for trastuzumab as well as another compound which would stand in for pegfilgrastim in both these markets.
However, the FDA returned the application for pegfilgrastim in October, and the company was also forced to withdraw the applications for pegfilgrastim and trastuzumab in the EU in August after a regulatory audit.
On Tuesday, Biocon said EU authorities have again accepted its approval request for the two drugs after the company completed its corrective actions.
Both are big-selling drugs, with Herceptin — the branded product for trastuzumab — generating estimated sales of over $5 billion a year globally — and Neulasta — the branded version of pegfilgrastim, generating around $4.6 billion in sales.
No biosimilar drug has been approved for these two products so far in the US, except for Friday’s approval of Biocon’s application.
“This is the first biosimilar trastuzumab to be approved by the U.S. FDA and opens the door to a high quality, more affordable option for the treatment of eligible cancer patients in the U.S,” said Arun Chandavarkar, CEO & Joint MD, Biocon.
“This approval represents a landmark achievement for the Biocon-Mylan Collaboration and is an important endorsement of our development and manufacturing capabilities in the area of monoclonal antibodies.”
The approval could have a benign impact on similar approval requests by the company for the same drug pending before regulators in Australia, Canada, Europe and other countries.
The data demonstrated that Ogivri” is highly similar to Herceptin and no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency, Mylan and Biocon said in a statement.
“The U.S. FDA’s approval for our biosimilar trastuzumab is indeed a crowning moment that puts us in an exclusive league of global biosimilar players,” said Kiran Mazumdar-Shaw, CMD Biocon.