The European Medicines Agency accepted applications to review Mylan NV and Biocon Ltd.'s biosimilars to Roche Holding AG breast cancer drug Herceptin and Amgen Inc.'s Neulasta.
The proposed biosimilar to Herceptin, also known as trastuzumab, is used to treat certain HER2-positive breast and gastric cancers, while the proposed biosimilar to Neulasta, also known as pegfilgrastim, is used to reduce the duration of neutropenia and the occurrence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.
Neutropenia is a condition in which the number of neutrophils in the bloodstream is decreased. Neutrophils are a type of white blood cell also known as polymorphonuclear leukocytes.
The decision follows an earlier withdrawal of both applications in response to an audit conducted by the European inspecting authority of Biocon's drug product facility.
Biocon has completed the corrective and preventive actions outlined as a result of the audit observations. The actions will be confirmed during re-inspection, which will be completed as part of the regulatory review process.
In October, the companies' biosimilar of Neulasta failed to win the approval of the U.S. Food and Drug Administration.
