Sandoz's Pegfilgrastim Under Review by EMA

Sandoz announced today that its biosimilar pegfilgrastim has been accepted for review by the European Medicines Agency (EMA).

Sandoz’s product, like its reference, the EU-approved Neulasta, is a long-acting granulocyte-colony stimulating factor. Pegfilgrastim is used in the prophylaxis of chemotherapy-induced febrile neutropenia, and many patients and physicians prefer the drug to short-acting filgrastim because of its less-frequent administration.

"Our goal is to improve patient access to important biologic medicines and the EMA [filing] acceptance of our biosimilar pegfilgrastim is a move towards doing just that," said Mark Levick, MD, PhD, global head of development, biopharmaceuticals. "If approved, we look forward to supporting cancer patients, healthcare professionals, and [payers] with our biosimilar pegfilgrastim."

Sandoz previously withdrew an application for its pegfilgrastim from the EMA; in February, Sandoz notified the Committee for Medicinal Products for Human Use (CHMP) that it would rescind its application for the proposed biosimilar that it had planned to market as Zioxtenzo.

CHMP had noted 2 main concerns about Zioxtenzo, neither of which Sandoz was able to resolve in the timeframe allowed by the regulator: first, study results were unable to demonstrate that concentrations of pegfilgrastim in the blood were the same in patients taking the biosimilar and the reference Neulasta. Second, Sandoz’s proposed manufacturing site had not received a certificate of Good Manufacturing Practice, and an inspection of the facility was still outstanding. “At the time of the withdrawal, the company had not demonstrated that Zioxtenzo is highly similar to Neulasta,” according to the EMA.

Sandoz also experienced disappointment for the drug in the United States; in July 2016, the FDA issued a complete response letter for the proposed biosimilar. Sandoz determined that it would conduct an additional pharmacokinetic study, and reported in early 2017 that it would resubmit its application to the FDA in 2018.

In addition to Sandoz, numerous other biosimilar developers are seeking US and EU regulatory approval for pegfilgrastim molecules; Cinfa Biotech, USV, Mylan—Biocon, Coherus, Gideon Richter, Apotex, and Adello are engaged in developing prospective biosimilars for the top-selling Neulasta.