FDA approves etanercept biosimilar for psoriasis, psoriatic arthritis
The FDA approved Erelzi, (etanercept-szzs, Novartis) for several indications, including chronic moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. The injectable biosimilar for Enbrel (etanercept, Amgen) is also approved for active psoriatic arthritis, including use in combination with methotrexate (MTX) in psoriatic arthritis patients who do not respond adequately to MTX alone.
There are almost 10 different biologics approved in the U.S. for psoriatic disease. The first biosimilar approved for psoriasis and psoriatic arthritis was Inflectra (infliximab-dyyb, Pfizer), a biosimilar for Remicade (infliximab, Janssen). Erelzi was the second biosimilar approved for psoriatic disease, according to an article published August 30 on Psoriasis.org.
“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, says in an FDA press release. “We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product.”
The FDA approved Erelzi based on structural and functional characterization evidence, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that shows Erelzi is biosimilar to Enbrel. But dermatologists and others should note that Erelzi is approved as a biosimilar; not an interchangeable product. Biosimilars are approved by FDA because they are highly similar to an already FDA-approved biological product and have no clinically meaningful differences from the specific biologic. Interchangeable biological products, on the other hand, not only meet the biosimilarity standard but are also expected to produce the same clinical result as the approved biologic in any given patient, according to FDA.