The Biocon plant in Bangalore, India, where it manufacturers biosimilars has been issued an FDA EIR after having been cited with a Form 483 last year. (Biocon)
Indian biosimilar maker Biocon has had the taint of an FDA manufacturing citation erased with an agency action that indicates a key plant in Bangalore, India, is now in compliance. The regulatory overhang had delayed Biocon and partner Mylan getting some products approved.
In a filing with the Bombay Stock Exchange over the weekend, Biocon said that the FDA issued an Establishment Inspection Report (EIR) for the plant in Bangalore where it makes its biosimilars. The EIR followed a pre-approval inspection of the plant in April and May.
The “EIR notifies that the inspection stands closed,” the company said.
Biocon’s difficulties with the sterile drug manufacturing plant began in spring 2017 when the FDA criticized the manufacturing facility where Biocon makes its biosimilars. In an eight-page, 10-observation Form 483, the FDA described problems across a variety of processes, leading Biocon to make plant changes.
Those changes led the FDA last fall to delay consideration of the partner’s biosimilar of Roche’s Herceptin so the agency had more time to review the manufacturing tweaks. The Herceptin biosimilar, which had gotten a good response from FDA reviewers, was approved in December, but the the facility’s problems also led the FDA last fall to issue a complete response letter for its biosimilar of Amgen blockbuster Neulasta.
The plant’s reversal of fortunes should not only bode well for Biocon and Mylan gaining approval of their version of Neulasta and other biosimilars those two are partnered on, but it is good news for Novartis. Novartis and Biocon, which have each had success developing biosimilars on their own, this year formed a partnership to produce “next generation” biosimilars.
They announced in January that they would share the costs equally for developing and commercializing multiple biosimilars in immunology and oncology. Sandoz, the generics unit of Novartis, will market them in the U.S., Canada and most of Europe, while India’s Biocon will take the rest of the world.
Jun 26, 2018