Mundipharma Receives Positive CHMP Opinion for Pegfilgrastim Biosimilar

Yesterday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Mundipharma’s pegfilgrastim biosimilar.

If it is authorized by the European Commission (EC), the biosimilar, which has the trade name Pegfilgrastim Mundipharma, will be authorized for sale throughout the European Union as a 6-mg solution for injection to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy.

Mundipharma, a network of independent companies that operates in 120 countries worldwide and distributes a number of biosimilars in the European Union, already has a marketed biosimilar pegfilgrastim, Pelmeg, which it acquired along with biosimilar developer Cinfa Biotech in 2018.

In November 2018, the EC granted a marketing authorization for that product for the same indication and same dose as the product for which the decision was rendered yesterday. Pelmeg gained its own positive recommendation from CHMP on the basis of a comprehensive package of data including a comparability study of pharmacodynamics and immunogenicity that was presented at the American Society of Hematology’s annual meeting in December 2017.

Since Pelmeg's authorization, Mundipharma has launched the biosimilar product in a range of markets, including Germany, the Netherlands, Ireland, and the United Kingdom, and has struck a deal with Budapest-based Egis Pharmaceuticals to distribute the product in Hungary, Romania, Lithuania, and Latvia.

The fact that Mundipharma already sells Pelmeg in the European context raises questions as to how the Pegfilgrastim Mundipharma product may fit in with the company's business strategy, although one possibility is that the product could be a separate brand name for the same biosimilar. In the European Union, duplicate marketing authorization applications are permitted on a case-by-case basis to help facilitate comarketing or for reasons concerning the public health.

Such duplicate authorizations are not uncommon for biosimilars; for example, earlier in 2019, the European Commission authorized Fresenius Kabi’s adalimumab biosimilar as both Kromeya and Idacio, and the 2 brands carry different indications.

Mundipharma did not respond to inquiries from The Center for Biosimilars^® to clarify whether Pegfilgrastim Mundipharma is a separately developed product or a duplicate of Pelmeg.