- 51-week clinical study confirms that Sandoz proposed biosimilar adalimumab matches reference medicine Humira * safety and efficacy profile
- Sandoz proposed biosimilar adalimumab is currently under review by the European Medicines Agency for the treatment of several immunological diseases
- Sandoz expects that approval of biosimilar adalimumab would further improve access to treatment for people living with immunological diseases
Holzkirchen, September 14, 2017 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announces new data on its proposed biosimilar adalimumab.
Data from a long-term study of patients continuously treated with the proposed biosimilar or the reference medicine show that efficacy and safety profiles of the two medicines match throughout 51 weeks of treatment in patients with moderate-to-severe chronic plaque psoriasis. Results were presented at the 26th Congress of the European Academy of Dermatology and Venereology (EADV) in Geneva, Switzerland.
"Patient access to often critical and expensive biologic medicines is one of the key challenges facing healthcare systems in developed economies today," said Mark Levick MD, PhD, Global Head of Development, Biopharmaceuticals, Sandoz.
He added: "Biosimilars are fundamentally changing the ability of healthcare systems to address this challenge. This clinical data supports the safety and efficacy of our proposed biosimilar adalimumab and offers a real alternative for patients living with immunological diseases."
Sandoz is committed to increasing patient access to high-quality biosimilars. We are the pioneer and global leader in biosimilars, with five biosimilars currently marketed worldwide, as well as a leading global pipeline. We plan to launch a total of five major oncology and immunology biosimilars between 2017 and 2020, including adalimumab, which is currently being reviewed by the European Medicines Agency.
Sandoz is well positioned to continue leading the biosimilars industry based on our experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, we benefit strongly from this unique blend of experience and expertise in many different market environments.
About the study
ADACCESS (NCT02016105) is a Phase III confirmatory randomized, double-blind, controlled, 51-week study to compare efficacy and safety between Sandoz biosimilar adalimumab and the reference medicine. The study consists of three treatment periods. During the first 17-week treatment period, eligible patients with active, but clinically stable, moderate-to-severe chronic plaque psoriasis were randomized to receive either biosimilar adalimumab or its reference medicine. In the second period, patients were re-randomized into four groups; the first two groups continued with their originally assigned treatment and the other two switched to alternating treatment every six weeks until Week 35. In the third period, patients received their initially assigned treatment up to Week 51 .
The Phase III confirmatory study demonstrates that Sandoz biosimilar adalimumab matches the reference medicine in terms of efficacy and safety up to Week 51. Psoriasis Area and Severity Index 75 (PASI 75) response rates for patients who received biosimilar adalimumab continuously throughout the study were 75.2% at Week 17 and 84.5% at Week 51, compared with 67.8% at Week 17 and 79.6% at Week 51 for patients who received continuous treatment with the reference medicine. PASI 75 response represents an improvement of at least 75% in the severity of a patient’s psoriasis. Investigator’s Global Assessment (IGA) response rates were also similar between the two groups in the study throughout the 51 weeks. There were no clinically relevant differences in adverse events between the two treatment groups, and the immunogenicity profiles were similar.