Mundipharma, a network of independent companies that operates in 120 countries worldwide, announced today that it has acquired biosimilar developer Cinfa Biotech. The deal will provide Mundipharma with access to B12019, a proposed biosimilar pegfilgrastim, referencing Neulasta, which received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2018.
Mundipharma, a network of independent companies that operates in 120 countries worldwide, announced today that it has acquired biosimilar developer Cinfa Biotech.
The deal will provide Mundipharma with access to B12019, a proposed biosimilar pegfilgrastim, referencing Neulasta, which received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2018, and which is awaiting a marketing authorization from the European Commission. If approved, the drug will be sold under the name Pelmeg.
Enrique Ordieres, president of Infarco, Cinfa’s parent company, said, “After having successfully developed and manufactured our first biosimilar, we strongly believe Mundipharma is best placed to take Pelmeg forward through the Cinfa Biotech acquisition. They have the pedigree and proven track record of launching biosimilars in Europe, have built strong partnerships with payers, hospital specialists and decision makers and have the deep local understanding of complex tender environments.”
Mundipharma has garnered extensive experience in European launches of biosimilars; the company is engaged in an ongoing partnership with Korean drug maker Celltrion to commercialize Remsima (biosimilar infliximab), Truxima (biosimilar rituximab), and Herzuma (biosimilar trastuzumab) in Europe.
Mundipharma indicated that its acquisition of Cinfa, a small company which was founded in 2013 to develop and manufacture biosimilars for the European marketplace, is directed not only to the commercialization of the pegfilgrastim product, but also to the development of new biosimilars in the future.
Warren Cook, director of the biosimilar business unit at Mundipharma, recently spoke at the 9th annual SMi Biosimilars and Biobetters conference in London, United Kingdom, where he reviewed the success of the company in its biosimilar efforts to date.
In his talk, Cook acknowledged that each biosimilar product his company has launched thus far has had its unique hurdles to commercialization; in the case of infliximab, for which the majority of the market is repeat prescriptions, encouraging a switch to the biosimilar from the reference product was key. The strategy to encourage switching was successful, as 3 years after launching the product, Remsima still holds the lion’s share of the infliximab market in Europe.
In the case of rituximab, which is most commonly used in hematology indications, instilling confidence in the extrapolation of indications was more important than undertaking a switch from the reference. Finally, with biosimilar trastuzumab, which entered the market after the reference product sponsor had launched a subcutaneously administered formulation, Mundipharma had to focus its efforts on convincing healthcare providers of the cost-savings rationale for using the intravenously administered biosimilar.
Regardless of the product type, however, Cook indicated that a primary focus of Mundipharma’s strategy is to engage with EU and national authorities, generate and disseminate local experience, and motivate all stakeholders to see the value of biosimilars.