The European Commission has granted a marketing authorization to Cinfa Biotech and Mundipharma’s biosimilar pegfilgrastim, Pelmeg, for all indications of the reference product, Neulasta.
The European Commission has granted a marketing authorization to Cinfa Biotech and Mundipharma’s biosimilar pegfilgrastim, Pelmeg, for all indications of the reference product, Neulasta.
The authorization of the drug indicated to reduce the duration and incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy follows a positive recommendation from the Committee for Medicinal Products for Human Use in September 2018. The biosimilar gained a positive recommendation 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.
“We hope this approval will significantly improve the lives of people who are affected by chemotherapy induced neutropenia and febrile neutropenia," Phillippe Bastide, head of biosimilars at Mundipharma, said in a statement. "The availability of this biosimilar represents an important opportunity to reduce healthcare costs while increasing access to an effective treatment option.”
Pelmeg will be the fourth biosimilar commercialized in Europe by Mundipharma, a network of companies that operates in 120 countries worldwide, which acquired Cinfa Biotech October 2018; 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. In addition to access to the biosimilar pegfilgrastim, acquisition of Cinfa Biotech provides Mundipharma with additional research and development capacity for future biosimilar products.
When it enters the European market, Pelmeg will become the third biosimilar pegfilgrastim product available; 2018 saw a spate of approvals in the pegfilgrastim space, with Coherus Biosciences’ Udenyca and Accord Healthcare’s Pelgraz authorized in September (Udenyca also earned FDA approval in November). Another biosimilar pegfilgrastim, Mylan and Biocon’s Fulphila, is currently awaiting EU authorization (the product has been FDA approved and launched in the United States).
The biosimilar will also compete with a range of EU-approved short-acting granulocyte colony-stimulating factor biosimilars and follow-ons, including Zarzio/Filgrastim Hexal, Accofil, Grastofil, Nivestim, and Ratiograstim/Tevagrastim.
Biosimilars Business Roundup For August 2023—Podcast Edition
September 5th 2023On this episode, we’re giving an overview of some of the biggest stories in the business space regarding biosimilars, like the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and some analyses about the health of the market.
How Streamlining Development Can Save the US Biosimilar Industry
August 20th 2023On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, expanded on ways to make biosimilar development faster and cheaper without compromising on safety and efficacy and how these practices can ensure a sustainable market for the future.
Part 3: BioRationality—FDA Webinar on Biosimilars Efficacy Testing Marks Major Step Forward
September 20th 2023In the final part of a 3-part series, Sarfaraz K. Niazi, PhD, gives his take on the FDA's recent workshop dedicated to streamlining biosimilar development and his opinion on what the industry can learn from the webinar presenters.
Part 2: FDA Workshop Shares Manufacturer Perspective on the Value of Clinical Efficacy Testing
September 18th 2023Although removing the requirement for clinical efficacy testing for biosimilar approval would reduce development costs of biosimilars, representatives from several biosimilar manufacturers argued in the second day of the FDA’s development workshop that clinical outcomes will not be affected.
2 Clarke Drive
Cranbury, NJ 08512