We added another feather in our cap with the U.S. FDA approval of Fulphila™, biosimilar Pegfilgrastim co-developed with our partner Mylan. Fulphila™ is the first FDA-approved biosimilar Pegfilgrastim and the second biosimilar from Biocon and Mylan’s joint portfolio approved in the U.S.
Pegfilgrastim is a long-lasting, pegylated form of recombinant granulocyte colony-stimulating factor that is prescribed for cancer patients to help them with some of the side-effects of their treatment. Certain cancer treatments such as chemotherapy can lead to a drop in the number of white blood cells made in the bone marrow, a condition known as neutropenia, thus temporarily weakening the immune system. Pegfilgrastim activates the cells in the bone marrow to generate white blood cells, thus reducing the duration of neutropenia and the incidence of febrile neutropenia (neutropenia with fever) that are a result of their chemotherapy treatment.
Type: Granulocyte growth factor
Indications: Reducing 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.
Global Sales: USD 4.7 billion*
(*Innovator Sales, Source: Company reports)
Pegfilgrastim is a part of our biosimilars portfolio partnered with Mylan in 2009. We developed our biosimilar Pegfilgrastim through recombinant DNA techniques, where the gene for filgrastim is inserted into specialized bacterial cells. These genetically modified bacteria are grown in fermenters, the filgrastim protein is purified, and then it is formulated for enabling stability of the drug. PEG (or polyethylene glycol) is attached to filgrastim to slow clearance of the carried protein from the blood, thus enabling an extended medicinal effect, reduced toxicity and longer dosing intervals.
We successfully surmounted the many challenges associated with the process and analytical development of a complex molecule like Pegfilgrastim. Our proposed biosimilar of Pegfilgrastim underwent extensive characterization and bioanalysis to establish similarity with the reference product in terms of structure, purity and functionality. In addition to analytical, functional and pre-clinical data, we generated clinical data from pivotal Pharmacokinetic / Pharmacodynamic (PK / PD) and confirmatory efficacy, safety and immunogenicity studies that were completed in 2016.
Data generated from these extensive laboratory and clinical studies helped establish analytical similarity, PK and PD equivalence, and similarity of clinical efficacy and safety of biosimilar Pegfilgrastim with the reference product. We subsequently made regulatory submissions for biosimilar Pegfilgrastim in various parts of the world, including U.S., EU, Australia and Canada, though our partner Mylan.
In June 2018, our partner Mylan received approvals from the U.S. FDA for Fulphila™, our biosimilar Pegfilgrastim, to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer. Subsequently, Fulphila™ has been launched in the U.S. as the first more affordable treatment option to branded Pegfilgrastim for oncology patients, in July 2018, by our partner Mylan.
The Pegfilgrastim approval represents a further endorsement of the Biocon-Mylan partnership’s ability to successfully develop complex molecules to exacting quality and regulatory standards.