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US FDA accepts application of Mylan & Biocon for biosimilar pegfilgrastim

The proposed biosimilar is used to reduce the duration of neutropenia (low count of neutrophils)

BS B2B Bureau  |  Bengaluru 

NV and Ltd today announced that the US Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed to Neulasta (pegfilgrastim), for filing through the 351(k) pathway.

The proposed to Neulasta is used to reduce the duration of (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with in adult patients treated with chemotherapy in certain types of cancer.

The goal date set under the User Fee Act (BsUFA) is October 9, 2017. 

Rajiv Malik, president, Mylan, commented, “We are proud of the acceptance of our BLA for proposed This is the second BLA accepted for review by as part of the and partnership within the past two months. The milestone builds upon the acceptance of regulatory filings for proposed in Europe, Australia, and Canada and reinforces our dedication and commitment to establishing a global platform for this product. Once approved, proposed will complement Mylan’s broad oncology portfolio focused on expanding access to more affordable treatments for multiple types of cancer.”

and are exclusive partners on a broad portfolio of biosimilars and generic insulin analogs. The proposed is one of the six biologic products co-developed by and for the global marketplace.

Dr Arun Chandavarkar, CEO and joint managing director, Biocon, added, “We are extremely pleased with the regulatory progress of our biosimilars in the US. The FDA's acceptance for review of our second BLA for a proposed developed by and is an outcome of our strong R&D and manufacturing capabilities. Once approved, our proposed will provide a high quality alternative to branded (Neulasta) for cancer patients during cytotoxic chemotherapy. It will expand our oncology portfolio and further enable us to fulfil our promise of making cancer-care affordable and accessible for patients across the globe.”

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US FDA accepts application of Mylan & Biocon for biosimilar pegfilgrastim

The proposed biosimilar is used to reduce the duration of neutropenia (low count of neutrophils)

The proposed biosimilar is used to reduce the duration of neutropenia (low count of neutrophils)
NV and Ltd today announced that the US Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed to Neulasta (pegfilgrastim), for filing through the 351(k) pathway.

The proposed to Neulasta is used to reduce the duration of (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with in adult patients treated with chemotherapy in certain types of cancer.

The goal date set under the User Fee Act (BsUFA) is October 9, 2017. 

Rajiv Malik, president, Mylan, commented, “We are proud of the acceptance of our BLA for proposed This is the second BLA accepted for review by as part of the and partnership within the past two months. The milestone builds upon the acceptance of regulatory filings for proposed in Europe, Australia, and Canada and reinforces our dedication and commitment to establishing a global platform for this product. Once approved, proposed will complement Mylan’s broad oncology portfolio focused on expanding access to more affordable treatments for multiple types of cancer.”

and are exclusive partners on a broad portfolio of biosimilars and generic insulin analogs. The proposed is one of the six biologic products co-developed by and for the global marketplace.

Dr Arun Chandavarkar, CEO and joint managing director, Biocon, added, “We are extremely pleased with the regulatory progress of our biosimilars in the US. The FDA's acceptance for review of our second BLA for a proposed developed by and is an outcome of our strong R&D and manufacturing capabilities. Once approved, our proposed will provide a high quality alternative to branded (Neulasta) for cancer patients during cytotoxic chemotherapy. It will expand our oncology portfolio and further enable us to fulfil our promise of making cancer-care affordable and accessible for patients across the globe.”

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Business Standard
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US FDA accepts application of Mylan & Biocon for biosimilar pegfilgrastim

The proposed biosimilar is used to reduce the duration of neutropenia (low count of neutrophils)

NV and Ltd today announced that the US Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed to Neulasta (pegfilgrastim), for filing through the 351(k) pathway.

The proposed to Neulasta is used to reduce the duration of (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with in adult patients treated with chemotherapy in certain types of cancer.

The goal date set under the User Fee Act (BsUFA) is October 9, 2017. 

Rajiv Malik, president, Mylan, commented, “We are proud of the acceptance of our BLA for proposed This is the second BLA accepted for review by as part of the and partnership within the past two months. The milestone builds upon the acceptance of regulatory filings for proposed in Europe, Australia, and Canada and reinforces our dedication and commitment to establishing a global platform for this product. Once approved, proposed will complement Mylan’s broad oncology portfolio focused on expanding access to more affordable treatments for multiple types of cancer.”

and are exclusive partners on a broad portfolio of biosimilars and generic insulin analogs. The proposed is one of the six biologic products co-developed by and for the global marketplace.

Dr Arun Chandavarkar, CEO and joint managing director, Biocon, added, “We are extremely pleased with the regulatory progress of our biosimilars in the US. The FDA's acceptance for review of our second BLA for a proposed developed by and is an outcome of our strong R&D and manufacturing capabilities. Once approved, our proposed will provide a high quality alternative to branded (Neulasta) for cancer patients during cytotoxic chemotherapy. It will expand our oncology portfolio and further enable us to fulfil our promise of making cancer-care affordable and accessible for patients across the globe.”

image
Business Standard
177 22