Sandoz, Cinfa, Mylan All Receive CHMP Recommendations for Pegfilgrastim Biosimilars

Today, Sandoz, Cinfa Biotech, and Mylan all revealed that they have received positive recommendations from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for proposed pegfilgrastim biosimilars referencing Neulasta.

LA-EP2006

Sandoz’s product, LA-EP2006, to be sold as Ziextenzo, was granted a positive opinion on the basis of data including positive phase 1 clinical data presented at the December 2017 San Antonio Breast Cancer Symposium. The molecule has also been studied in phase 3 clinical trials in patients undergoing chemotherapy.

Sandoz’s Mark Levick, MD, PhD, global head of development of biopharmaceuticals, said in a statement that he expects the drug to provide greater access to treatment for febrile neutropenia in European nations; "while pegfilgrastim is a proven effective and safe treatment for febrile neutropenia-related infections, many cancer patients throughout Europe are not treated with this medicine...If approved, we will do our best to provide this critically-important option to all patients who stand to benefit from it."

Sandoz had previously put the molecule forward for EMA review, but withdrew its application in October 2017 after CHMP raised concerns that Sandoz was not able to resolve in the timeframe permitted by the regulator.

B12019

Cinfa, in announcing its own positive opinion for B12019, which it hopes to sell under the brand name Pelmeg, also saw implications for patient access. “The positive CHMP opinion for our proposed pegfilgrastim biosimilar product…is an important milestone in our effort to provide patients with high-quality and affordable treatment options,” said Ruediger Jankowsky, PhD, managing director of Cinfa, in a statement.

The proposed 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.

Fulphila

Mylan and its partner Biocon also received a positive opinion for thier pegfilgrastim biosimilar, Fulphila, which is already approved—and launched—in the United States.

Mylan’s president, Rajiv Malik, said, "We are very proud to be a leader in bringing the first wave of biosimilars to the European market and driving greater access to more affordable treatment options for patients living with chronic and life-threatening illness such as cancer. Receiving CHMP positive opinion for our pegfilgrastim biosimilar, Fulphila, is a key milestone in this journey."

The positive CHMP opinions for all of the pegfilgrastim products will now be forwarded to the European Commission for a final decision. If the European Commission grants marketing authorizations, they could become the first pegfilgrastim biosimilars authorized in the European Union. Biosimilar developers Coherus and Accord are also awaiting the Commission's decision on their pegfilgrastim molecules.