Bangalore based Biocon announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s (Biocon’s partner for biosimilar development) Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta® (pegfilgrastim), an anti cancer drug.
The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.
The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Oct. 9, 2017.
“We’re proud of the FDA acceptance of our BLA for proposed biosimilar pegfilgrastim. This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months”, said Rajiv Malik President Mylan.
The milestone builds upon the acceptance of regulatory filings for proposed biosimilar pegfilgrastim in Europe, Australia, and Canada, once approved, proposed biosimilar pegfilgrastim will complement Mylan’s broad oncology portfolio focused on expanding access to more affordable treatments for multiple types of cancer, Malik added.
The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.
The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Oct. 9, 2017.
“We’re proud of the FDA acceptance of our BLA for proposed biosimilar pegfilgrastim. This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months”, said Rajiv Malik President Mylan.
The milestone builds upon the acceptance of regulatory filings for proposed biosimilar pegfilgrastim in Europe, Australia, and Canada, once approved, proposed biosimilar pegfilgrastim will complement Mylan’s broad oncology portfolio focused on expanding access to more affordable treatments for multiple types of cancer, Malik added.
Biocon said that the FDA's acceptance for review of this biosimilar is an outcome of the company’s strong R&D and manufacturing capabilities.