EMA to Review Cinfa Biotech's Pegfilgrastim Biosimilar

Cinfa Biotech has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for biosimilar pegfilgrastim.

The application includes data revealed at a poster presentation¹ at the European Society for Clinical Oncology (ESMO)’s 2017 meeting in Madrid, Spain. Karsten Roth, PhD, and colleagues demonstrated the comparability of B12019 with the reference pegfilgrastim in 2 clinical studies. The first showed pharmacokinetic and pharmacodynamic (PD) comparability of the drugs at a dose of 6 mg in a randomized, double-blind, 2-way crossover study in 172 healthy volunteers. The second demonstrated immunogenicity and PD comparability of the proposed biosimilar and its reference at a dose of 3 mg in a randomized, double-blind, 3-period, 2-sequence crossover study in 96 healthy volunteers.

Ruediger Jankowsky, PhD, managing director of Cinfa Biotech, said of the application’s review by the EMA, “This is a major milestone in our [endeavor] to provide patients with high-quality and affordable treatment options. We are proud of having completed the development of B12019 in just [4] years. It confirms our highly efficient development approach.”

B12019 is the Pamplona-based biosimilar developer’s first product candidate, and the company has chosen a notably difficult development project for its initial effort. While the European marketplace has outpaced the United States in its biosimilar product approvals to date, no pegfilgrastim biosimilars have yet been approved for marketing in Europe, and Amgen’s originator product (marketed under the names Neulasta and Ristempa) retains its hold on the market.

Among the companies that have withdrawn marketing applications for pegfilgrastim biosimilars from the EMA are Sandoz (which had hoped to market a product under the brand name Neupopeg) and Mylan—Biocon. The latter development collaboration plans to resubmit its application after its facilities in Bangalore have been re-inspected by European authorities after an initial inspection raised numerous concerns. The Mylan—Biocon product is currently under review by the FDA, and a regulatory decision for the product is expected on Monday, October 9.

Reference

1. Roth K, Wessels H, Hoefler, J, et al. Pharmacokinetic and pharmacodynamic comparability of B12019: a proposed pegfilgrastim biosimilar. Presented at the European Society for Medical Oncology 2017 Congress; September 8-12, 2017; Madrid, Spain. Abstract 1573P. cslide.ctimeetingtech.com/library/esmo/browse/search/51E#2Bb4e.