New Data on Proposed biosimilar Adalimumab – Announced by Novartis Division- Sandoz

Sandoz, pioneer and global leader in biosimilars have announced new data on its proposed biosimilars, adalimumab. According to data from a long term study that is conducted in the patient treated with the biosimilar or the reference, medicine shows that for both the medications the efficacy and safety profiles match throughout 51 weeks of treatment. This study was conducted in patients with chronic plaque psoriasis. The study results were presented at the 26th Congress of the European Academy of Dermatology and Venereology (EADV) in Geneva, Switzerland.

Mark Levick MD, PhD, Global Head of Development, Biopharmaceuticals, Sandoz said, “Patient access to often critical and expensive biologic medicines is one of the key challenges facing healthcare systems in developed economies. Biosimilars are fundamentally changing the ability of healthcare systems to address this challenge. This clinical data support 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.”

The phase III randomized double blind trial called ADACCESS is designed to compare the efficacy and safety between Sandoz biosimilar adalimumab with reference medicine. This study mainly comprises of three treatment periods. During the first 17 week treatment, the patients with moderate-to-severe chronic plaque psoriasis were randomized to receive either adalimumab or its reference medicine.

During the second period, the patients were randomized again into four groups i.e., re-randomization. The first group continued with the originally assigned treatment and other two switched to alternative treatment every six weeks until week 35. During the third period, the patients received the initially assigned treatment up to week 51.

In the phase III study, it is demonstrated that Sandoz biosimilar adalimumab and reference medicine efficacy and safety matches to week 51. The study does not show any clinically relevant differences in the adverse events of adalimumab and reference medicine.


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