The FDA today approved Erelzi, a biosimilar to etanercept (Enbrel), for all the indications included in the labeling of the reference product, according to manufacturer Sandoz.
The injectable medication can be used for these conditions:
- Moderate to severe rheumatoid arthritis, alone or in combination with methotrexate
- Moderate to severe polyarticular juvenile idiopathic arthritis in patients ages 2 years and older
- Active psoriatic arthritis, including as a combination therapy with methotrexate for patients with an inadequate response to methotrexate monotherapy
- Active ankylosing spondylitis
- Moderate to severe plaque psoriasis in adults
In its separate news release, the to review the biosimilar product's prescribing information for details about its use. Included are the same boxed warnings about risks of serious infections and certain hematologic malignancies also carried on etanercept's label.
"The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases," , director of the agency's Center for Drug Evaluation and Research, said in the news 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," she said.
In July, the FDA Arthritis Advisory Committee unanimously recommended approval of the biosimilar. It had been evaluated in four pharmacokinetic studies that included 216 healthy volunteers and in a clinical study of 531 patients with chronic plaque psoriasis that confirmed "efficacy and safety similarity."
Pharmacodynamic and immunogenicity data also were reviewed during the approval process.
The FDA also stated that Erelzi is a biosimilar, not an interchangeable product. The designation of interchangeable indicates that it's safe to switch between the reference and biosimilar products.
A biosimilar to infliximab (Remicade) known as Inflectra, also has been approved, but has faced difficulties in reaching the marketplace because of patent disputes. In addition, a biosimilar to adalimumab (Humira) has demonstrated clinical equivalence in a phase III study.
An application for the biosimilar also is under review by the European Medicines Agency.
Sandoz is a Novartis company.