Biocon and Mylan say their plant is good to go as FDA decision nears for their Herceptin copy

Biocon research lab
Biocon has resolved FDA concerns about a plant in India, setting it and Mylan up to potentially win FDA approval for the first Herceptin biosimilar.

Biocon has resolved FDA concerns about a biologics plant in India, a step that sets it and partner Mylan up to potentially win the first U.S. approval of a biosimilar of Roche’s blockbuster cancer drug Herceptin.

It was good news Biocon and Mylan but in what turned out to be a double whammy for Roche and its $6.8 billion behemoth cancer treatment, partners Biogen and Samsung also announced today that their biosimilar Ontruzant had become the first to be approved in Europe.

Biocon in a filing said (PDF) that it has been notified by the FDA that an inspection that had faulted the Bangalore sterile plant for a variety of shortcomings had been closed by the FDA. The Indian drugmaker has been working to resolve the issues since an inspection in the spring had raised questions about Bicon's aseptic filling processes. Similar concerns raised by EMA inspectors led Biocon and Mylan to pull their applications for biosimilars of Herceptin and another drug in Europe.

RELATED: FDA slams Biocon sterile plant where Herceptin biosimilar is to be produced

Biocon’s news today comes less than two weeks before the Dec. 3 date that the FDA has set for considering approval of the biosimilar. The original action date was Sept. 3, but the FDA delayed that for three months after seeking additional info from Mylan and Biocon.

Hot on their heels are copies of Herceptin from partnerships of Amgen-Allergan and Teva-Celltrion. Teva has said it expects an FDA regulatory action in the first half of 2018. Amgen and Allergan have already won FDA approval for the first biosimilar of Roche’s $3 billion seller Avastin.

Roche has been fighting the advances with patent lawsuits, and executives have tried to downplay the potential damage, pointing to new cancer drugs that they say are the future for treatment, but recent results and developments illustrate the near-term future as biosimilars of Roche’s top cancer medicines advance around the world.

RELATED: Biosimilar threat starts to creep up on Roche as Rituxan loses ground

In the third quarter, the Swiss drugmaker saw sales in Europe for its top seller Rituxan slip 16% year over year after only the second quarter the Roche brand faced biosim competition there. In 2016, Rituxan turned in $7.3 billion in global sales. Avastin, another of Roche's cancer blockbusters, slumped in the third quarter as well, with sales off 4% around the world while Herceptin's global sales were flat.

Earlier this month, Roche’s Genentech confirmed that 130 workers at a plant in Vacaville, California, will be laid off by the end of the year after determining that fewer are needed for the demand it is forecasting for its injected medications.