FDA Accepts the First Biosimilar Application under the BPCIA


Sandoz announced yesterday that the FDA accepted its Biologics License Application (BLA) for filgrastim. This marks the first acceptance of a biosimilars application (351(k)) filed under the pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

Filgrastim is an analog of granulocyte colony-stimulating factor (G-CSF). The reference product – Amgen’s NEUPOGEN® – is indicated to decrease the incidence of infection in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia. NEUPOGEN® is a small protein, containing 175 amino acids, that is manufactured by recombinant DNA technology in bacteria.

As defined by the BPCIA, a biosimilar biologic is a biological product that is highly similar to the reference product and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency. The BPCIA also provides for approval of a biosimilar biologic under the heightened standard of interchangeability. To be approved as an interchangeable, in addition to the requirements to demonstrate biosimilarity, the biosimilar product must also produce the same clinical result as the reference product in any given patient, and the risk in terms of safety or diminished efficacy between alternating or switching between use of the reference product and the biosimilar is not greater than the risk of continuation with the reference product. Interchangeability is considered the “holy grail” for biosimilars because it provides a period of exclusivity for the first approved interchangeable biologic.

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