Adello Biologics Submits BLA for Filgrastim Biosimilar

Adello Biologics, a New Jersey-based biosimilar developer previously named Therapeutic Proteins International, announced this week that its Biologics License Application (BLA) for a biosimilar filgrastim candidate has been accepted for review by the FDA. The company did not disclose a biosimilar user fee action date for a regulatory decision by the FDA.

Peter Moesta, PhD, CEO of Adello said, “If approved, we are excited to be able to offer an additional, important treatment choice that can prevent serious complications for patients.”

Adello’s BLA includes data from a double-blind, single-dose, 2-period crossover pharmacokinetic (PK) and pharmacodynamic (PD) study of its product in comparison with the reference filgrastim. The study, which included 54 healthy volunteers, demonstrated that Adello’s product had similar PK and PD properties to the reference drug. Safety and immunogenicity were also similar between the 2 products.

Reference filgrastim (Amgen’s Neupogen) is a granulocyte colony-stimulating factor used to treat or prevent chemotherapy-induced neutropenia. To date, 1 biosimilar filgrastim, Sandoz’s Zarxio, is available in the United States.

Adello also reported that it is developing a biosimilar pegfilgrastim, referenced on Neulasta, and a biosimilar adalimumab, referenced on Humira, in addition to a number of other products that are currently in preclinical development.