Biocon gets FDA approval to produce pegfilgrastim in India

Biocon Biologics has won FDA approval of to begin producing the blood cell booster Fulphila for Mylan at its Bengaluru facility in India. (Biocon)

Biocon Biologics has won FDA approval of a supplemental Biologics License Application to begin producing Fulphila (pegfilgrastim) for Mylan at its Bengaluru facility in India.

The drug is a blood cell booster used to treat cancer patients by helping decrease the incidence of infection in cancer patients with non-myeloid malignancies who are getting myelosuppressive anti-cancer drugs.

The regulatory agency conducted a pre-approval inspection of the plant in mid-September. 


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The Biocon/Mylan partnership has commercialized three of its co-developed biosimilars in U.S., Canadian, European, and Australian markets.

“This approval will help us better meet global patient needs for Fulphila,” Dr. Christiane Hamacher, Biocon Biologic’s chief executive, said in a statement. “Continued penetration of biosimilars will enable higher cost savings for the U.S. healthcare system leading to expansion of patient access to high-quality, affordable biologics.”

With the regulatory agency approval of Biocon’s additional facility, it and Mylan will be in a position to meet increasing patient demand for the drug in the U.S. where introduction of the biosim has expanded the overall market, the company said. Fulphila has already been approved in the European Union, Australia and Canada.

Fulphila, which is a knockoff of Amgen’s Neulasta, has already captured more than 15% of the prefilled syringe market, and Mylan has said it is using a patient-focused call center, reimbursement support and copay assistance to drive their market share higher.

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