The European Commission recently approved Erelzi, a biosimilar etanercept drug manufactured by the Sandoz division of Switzerland’s Novartis, for all therapeutic indications of its reference medicine Enbrel (etanercept), including ankylosing spondylitis.
The June 27 announcement followed an extensive analytical, preclinical and clinical program focused on Erelzi, formerly known as GP2015. Four clinical studies involving 216 healthy volunteers confirmed that its activity and overall response was similar to that reported for Amgen’s TNF inhibitor Enbrel.
Erelzi also demonstrated its efficacy and safety in the pivotal Phase 3 EGALITY clinical trial (NCT01891864). This trial involved 531 patients with chronic plaque psoriasis — an inflammatory disease like ankylosing spondylitis — who were randomized to receive Erelzi or Enbrel. Both drugs had the same therapeutic potency, as measured by the Psoriasis Area and Severity Index (PASI), and also a similar safety profile to the reference medicine.
“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,” Carol Lynch, global head of biopharmaceuticals at Sandoz, said in a company press release. “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.”
The use of Erelzi to all indications approved for use on the reference product label — namely ankylosing spondylitis, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and plaque psoriasis — was based on the similarities demonstrated between the drug and its reference medicine.
Erelzi, which the U.S. Food and Drug Administration approved in August 2016, will be sold as a pre-filled syringe and as an auto-injector pen — an administration method designed for patient safety, comfort and convenience, said Sandoz, which now has five biosimilar products approved in Europe.
According with its label, the drug should be given to adults in a regimen of 25 mg twice a week or 50 mg once a week. The dosage for children is calculated according to their weight. Erelzi should not be used in dosages lower than 25 mg.
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