Cavoley (pegfilgrastim biosimilar) / Gedeon Richter, Stada - LARVOL DELTA

Safe switch of treatment from the reference product to RGB-02, a proposed biosimilar pegfilgrastim: analysis of the results of three clinical trials (ESMO 2018) - P3; "Treatment switch from Neulasta® to RGB-02 can be considered safe while maintaining the therapeutic effect of pegfilgrastim therapy."

Clinical • Breast Cancer

Efficacy and safety of RGB-02, a proposed biosimilar pegfilgrastim to prevent chemotherapy-induced neutropenia: Results of a randomized, double-blind, phase III clinical study vs. reference pegfilgrastim in patients with breast cancer receiving docetaxel/doxorubicin (ESMO 2017) - P3; "Therapeutic equivalence and similar safety profiles between RGB-02 and Neulasta® as once-per-cycle administration could be demonstrated. RGB-02 can provide a biosimilar alternative for the prevention of neutropenia."

P3 data • Breast Cancer

EMA accepts Neulasta biosimilar resubmission (The Pharma Letter) - "The European Medicines Agency has accepted the regulatory resubmission of its proposed biosimilar to Amgen’s (Nasdaq: AMGN) Neulasta (pegfilgrastim) from Gedeon Richter (RICHT: HB), Hungary’s largest drugmaker."

European regulatory • Biosimilar

Stada: Capital Markets Day 2016 (Stada) - Anticipated launch in neutropenia in 2017

Anticipated biosimilar launch • Biosimilar

EMA started the evaluation of Richter’s marketing authorisation application for biosimilar pegfilgrastim (Gedeon Richter Press Release) - "Gedeon Richter...today announced that the European Medicines Agency (EMA) has accepted Richter's regulatory submission for its proposed biosimilar to Amgen's Neulasta (pegfilgrastim)...biosimilar pegfilgrastim is expected to be launched under both Richter and STADA labels in geographical Europe (excluding Russia) following the patent expiry of the original product. Richter is seeking approval for the same indications as the reference product."

European regulatory • Licensing / partnership • Biosimilar

RGB-02 (biosimilar pegfilgrastim) in the treatment of chemotherapy-induced neutropenia. (PubMed, Future Oncol) - "The clinical analyses in three randomized clinical studies provided comparative data between RGB-02 and Neulasta, in a Phase III study patients receiving docetaxel-doxorubicin chemotherapy treatment equivalence was found. No difference was detected in any safety measure including immunogenicity; treatment switch, from the reference product to RGB-02 proved safe. Long-acting pegylated filgrastim RGB-02 has successfully accomplished various steps of biosimilar development."

Journal

Efficacy and safety of RGB-02, a pegfilgrastim biosimilar to prevent chemotherapy-induced neutropenia: results of a randomized, double-blind phase III clinical study vs. reference pegfilgrastim in patients with breast cancer receiving chemotherapy. (PubMed, BMC Cancer) - P3; "Treatment equivalence in reducing the duration of chemotherapy induced neutropenia between RGB-02 and Neulasta® could be demonstrated. Similar efficacy and safety profiles of the once-per-cycle administration of RGB-02 and the pegfilgrastim reference were demonstrated."

Clinical • Journal • P3 data

Efficacy and safety of RGB-02, a pegfilgrastim biosimilar to prevent chemotherapy-induced neutropenia: Results of a randomized, double-blind phase III clinical study vs. reference pegfilgrastim in patients with breast cancer receiving chemotherapy (BMC Cancer) - P3, N=239; "The mean duration of severe neutropenia in Cycle 1 was 1.7 (RGB-02) and 1.6 days (reference), with a difference (LS Mean) of 0.1 days (95% CI -0.2, 0.4). Equivalence could be established as the CI for the difference in LS Mean lay entirely within the pre-defined range of ±1 day."

P3 data