Drugs

Apotex Wants Neulasta Biosimilar Requirements

Apotex is petitioning FDA to issue specified requirements for biosimilar applicants referencing Amgen’s Neulasta (pegfilgrastim). Specifically, the petition asks that FDA:

require all biosimilar applicants referencing Neulasta demonstrate “no clinical meaningful differences” by conducting a comparative clinical efficacy study in at least one of Neulasta’s indicated patient populations;
require all biosimilar applicants referencing Neulasta that intend to rely on comparative clinical pharmacokinetic, pharmacodynamics, and immunogenicity in all or some healthy subjects to conduct sufficient clinical PK, PD, and immunogenicity studies in at least one of Neulasta’s indicated patient populations to demonstrate a correlation between diseased patients and healthy subjects and to demonstrate evidence where applicable that the healthy subject data is significantly more sensitive than the representative intended patient population;
require all biosimilar applicants referencing Neulasta to conduct immunogenicity studies in at least one of Neulasta’s indicated patient populations and over at least four and preferably six cycles of chemotherapy; and
require all biosimilar applicants that have not done the first three items to withdraw their applications from consideration until the further studies have been done.

Apotex says that underlying its petition is the belief that for healthy subjects with normal absolute neutrophil counts, comparative clinical studies administering a biosimilar alone would not demonstrate “no clinically meaningful differences” between the proposed biosimilar and Neulasta for one of the Neulasta indications. In particular, it says, demonstrating a comparable boosted absolute neutrophil count in a healthy patient would not necessarily predict a comparable decreased incidence of infection (as manifested by febrile neutropenia) for cancer chemotherapy patients receiving pegfilgrastim after one or multiple chemotherapy cycles.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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