Noticia de Contratación

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 23 March 2018 [1].

The EC’s approval is based on a comprehensive data package confirming that Zessly matches the safety, efficacy and quality of the reference biological, Johnson & Johnson and Merck’s Remicade (infliximab).

The EC approval was based on review of a comprehensive development programme, including analytical, preclinical and clinical data, which confirmed Zessly matched its reference medicine, Johnson & Johnson and Merck’s Remicade (infliximab), in terms of safety, efficacy and quality. It included data from the clinical phase III confirmatory study in rheumatoid arthritis (REFLECTIONS B537-02), which met its primary endpoint, demonstrating equivalent efficacy of Zessly to the reference medicine as measured by the American College of Rheumatology 20 (ACR20) response at Week 14.

Sandoz already has six biosimilars approved in the European Union: Binocrit (epoetin alfa), Erelzi (etanercept), Omnitrope (somatropin), Rixathon (rituximab), Riximyo (rituximab) and Zarzio (filgrastim) [2]. The company also gained US approval for its filgrastim biosimilar, Zarxio (filgrastim-sndz), in March 2015 – the first biosimilar approved in the US and for its etanercept biosimilar, Erelzi (etanercept-szzs) in August 2016 [3]. It has also submitted applications for approval of its pegfilgrastim (LA-EP2006) and rituximab (GP2013) biosimilars to the US Food and Drug Administration (FDA) [4, 5]. Its pegfilgrastim application, however, was rejected by FDA in July 2016 [6].

Zessly marks the third approval for a Sandoz biosimilar in the last 12 months and Novartis says that it expects several more major oncology and immunology launches globally by 2020.