The European Commission has approved the use of Erelzi – a biosimilar to Enbrel (etanercept) – to treat juvenile arthritis and several other chronic inflammatory diseases. Erelzi is produced by Sandoz, part of Switzerland’s Novartis group.
Erelzi, which won U.S. Food and Drug Administration approval in August 2016, is available as a pre-filled syringe and an auto-injector pen (SensoReady), which lets patients administer the drug easily, safely and comfortably.
The therapy is now available in Europe for patients with juvenile idiopathic arthritis, rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), psoriatic arthritis and plaque psoriasis.
Erelzi’s approval was based on positive results from a comprehensive research program — including preclinical and clinical studies — showing that the drug had similar efficacy, safety and quality profiles as its reference medicine, Enbrel (manufactured by Amgen).
“Immunology is a priority for us and today’s approval of Erelzi, the second in this therapy area in as many weeks, clearly demonstrates our commitment to patients. This can also be seen in the progress we are making in our immunology pipeline with two recent file acceptances in Europe” Carol Lynch, global head at Sandoz, said in a company press release. “As part of the wider Novartis immunology portfolio, Erelzi further expands the offering to healthcare professionals and patients in Europe. Its availability is expected to result in more patients being treated with much-needed biologics.”
A 2016 study, “GP2015, a proposed etanercept biosimilar: Pharmacokinetic similarity to its reference product and comparison of its autoinjector device with prefilled syringes,” investigating the drug behavior and effects of Erelzi — formerly known as GP2015 — showed that this drug had a similar safety and tolerability profile as its reference medicine.
In addition, the 52-week Phase 3 EGALITY study (NCT01891864) in psoriasis patients further supported these results. In the trial, researchers found no difference in the mean Psoriasis Area and Severity Index responses between patients receiving either Erelzi or Enbrel.
Results also showed no difference in terms of safety and immune system activation between Erelzi and its reference product.