UK-based pharmaceutical company Mylan and Indian biopharmaceutical company Biocon have received the European Medicines Agency (EMA) acceptance for review of Mylan's Marketing Authorisation Application (MAA) for the Pegfilgrastim biosimilar.
Pegfilgrastim is used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy, but with the exception of chronic myeloid leukaemia and myelodysplastic syndromes.
Mylan president Rajiv Malik said: “This milestone in our Pegfilgrastim programme represents yet another important step in bringing more affordable versions of these critical products to market, with Europe representing an exciting opportunity for Mylan in this area.”
The drug is administered to patients affected with cancer, with an aim to reduce some of the side-effects of their treatment.
The biosimilar helps reduce the duration of neutropenia equalling low levels of neutrophils, a type of white blood cell that combats infections.
It also reduces the incidence of febrile neutropenia, otherwise known as neutropenia with fever, which is caused after the cancer patients receive their chemotherapy treatment.
Developed jointly by Mylan and Biocon, the proposed Pegfilgrastim biosimilar received EMA's acceptance of the submission for review.
The application not only includes analytical, functional and pre-clinical data, but also clinical data from major Pharmacokinetic / Pharmacodynamic (PK / PD), as well as confirmatory efficacy, safety and immunogenicity studies completed earlier this year.
Pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for markets across the globe.
Mylan possesses exclusive commercialisation rights for the proposed biosimilar in the US, Canada, Australia, Japan, New Zealand, and the European Union (EU), along with the European Free Trade Association countries.
Biocon CEO and joint managing director Arun Chandavarkar said: “Once approved, this product will enable enhanced access to a cost-effective alternative for patients undergoing chemotherapy in the EU.
“We are committed to bring a diversified portfolio of high-quality, life-enhancing biosimilars to patients globally.”
Biocon owns co-exclusive commercialisation rights in collaboration with Mylan for the drug within the rest of the world.