Sandoz Releases New Clinical Study Data for Adalimumab Biosimilar

At the 26th Congress of the European Academy of Dermatology and Venereology in Geneva, Switzerland, Sandoz announced positive data from a phase 3 confirmatory study to compare the efficacy and safety of Sandoz’s proposed biosimilar adalimumab, GP2017, with its reference.

The randomized, double-blind, controlled, 51-week study consisted of 3 treatment periods. In the first period of 17 weeks, patients with active, clinically stable, moderate to severe chronic plaque psoriasis were randomized to receive either GP2017 or the reference adalimumab. In the second period, patients were re-randomized into 4 groups. The first 2 groups continued with their previously assigned treatments while the other 2 groups were switched to an alternating treatment every 6 weeks until week 35 of the study. In the third period, patients received the initially assigned treatment until week 51.

The study demonstrates that GP2017 and its reference have similar efficacy and safety to week 51. Psoriasis area and severity index 75 (defined as an improvement of at least 75% in the severity of a patient’s psoriasis) response rates for patients who received the biosimilar continuously for 51 weeks versus patients who received the reference continuously for the same period were as follows:

• 75.2% versus 67.8% at week 17
• 84.5% versus 79.6% at week 51

There were no clinically relevant differences in adverse events between the 2 treatment groups, and immunogenicity profiles between the groups were similar.

The European Medicines Association is currently reviewing Sandoz’s application, which the drug maker filed in May of 2017. In the US, Sandoz is continuing phase 3 development of the drug.

Mark Levick MD, PhD, Sandoz’s global head of development, biopharmaceuticals, said of the proposed biosimilar, “Patient access to often critical and expensive biologic medicines is one of the key challenges facing healthcare systems in developed economies today. Biosimilars are fundamentally changing the ability of healthcare systems to address this challenge.”

If Sandoz’s drug is approved in the European Union, it will join the following EMA-approved adalimumab biosimilars: Amgen’s Amgevita (the same drug as Solymbic, which has been approved to be marketed for all indications of Amgevita except for polyarticular juvenile idiopathic arthritis) and Samsung Bioepis’ Imraldi. The EMA’s Committee for Medicinal Products for Human Use has also adopted a positive opinion of Boehringer Ingelheim’s Cyltezo, and the European Commission is expected to authorize the drug for marketing. None of the above biosimilar treatments are expected to launch before 2018 due to patent exclusivity for Humira, the reference adalimumab.