The U.S. Food and Drug Administration (FDA) has approved Novartis‘ Erelzi (etanercept-szzs) for a number of inflammatory diseases, including rheumatoid arthritis (RA). Erelzi, a TNF inhibitor, was approved as a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.
A biosimilar is very close to an identical copy of an already-approved biological therapy manufactured by a different company. Its approval is based on proof that it is highly similar to the FDA-approved product, especially in safety and effectiveness.
“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” Dr. Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a 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.”
Enbrel is a soluble TNF receptor designed to bind specifically to TNF and impair its interaction with the TNF receptors at the cell surface, blocking the biological responses that are induced or regulated by this factor. TNF is a crucial regulator of normal inflammatory and immune responses, and participates in the exacerbated inflammation found in patients with RA, polyarticular juvenile idiopathic arthritis (JIA), psoriasis, psoriatic arthritis, and ankylosing spondylitis (AS), a type of arthritis that affects the spine. By blocking TNF signaling, Enbrel has been shown to improve symptoms in those patients.
After an extensive review of preclinical and clinical studies that analyzed the drug’s functional characterization, clinical immunogenicity, pharmacodynamics and pharmacokinetics, and clinical safety and effectiveness, Erelzi was shown to be a biosimilar to Enbrel. It has been approved as a biosimilar, not as an interchangeable product.
Erelzi is approved to be administered by intravenous injection in patients with moderate to severe RA, either alone or in combination with Rasuvo (metothrexate); moderate to severe polyarticular JIA patients aged two or older; active psoriatic arthritis patients in combination with Rasuvo in patients who don’t respond to Rasuvo as monotherapy; active AS; and chronic moderate to severe plaque psoriasis in patients age 18 or older who are candidates for phototherapy or systemic therapy.