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.
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:
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.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis
October 19th 2024A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.
Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review
October 15th 2024Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.