Europe approves Mundipharma’s Neulasta biosimilar
Mundipharma’s drug Pelmeg (pegfilgrastim) was granted approval by the European Commission (EC) for the treatment of chemotherapy induced neutropenia in adult patients. The treatment is for the reduction in the duration of the condition, and the incidence of febrile neutropenia by stimulating bone marrow production.
This approval comes after the Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion on the drug.
A positive opinion by the CHMP was based on the regulatory submission of data that showed biosimilarity from analytical, biofunctional, and clinical study comparisons of Pelmeg to the originator biologic, Neulasta. Pelmeg demonstrated comparable pharmacodynamics, pharmacokinetics, and immunogenicity in the data.
The drug was developed by Cinfa Biotech, which Mundipharma acquired in October 2018. Bastide told us that Mundipharma acquired Cinfa Biotech after the CHMP approval submission had already been completed.
According to Bastide, Cinfa was, “one of the first biosimilar development companies to develop a pegfilgrastim [biosimilar] in line with the latest CHMP draft guidance for development of similar biological products containing recombinant G-CSF.”
Bastide explained that after the acquisition the company worked to ensure that all requirements needed for EC approval were met. Mundipharma, he explained, is also working to prepare for the launch of Pelmeg by “harnessing [the] full strength and capabilities that the Mundipharma network can offer including commercial, supply chain, sales support, legal and IP.”
The network has previously commercialized three other biosimilars across multiple European markets, and said that it aims to use its experience to expedite the launch.
Celltrion, a member of the Mundipharma network, launched its Herceptin biosimilar, Herzuma (trastuzumab) earlier this year. It was the second Herceptin biosimilar to be launched in Europe as it followed MSD’s (Merck & Co. in North America) Ontruzant.
Mundipharma has also launched Celltrion’s biosimilars of Remicade (infliximab) and Roche’s Mabthera (rituximab) within Europe.
