People who suffer from Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Plaque Psoriasis just got some good news: A new drug called Erelzi just received FDA approval to help manage and treat these disorders.
Erelzi (etanercept-szzs) is administered by injection and is now approved for the treatment of the following conditions:
- moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX);
- moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older;
- active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone;
- active ankylosing spondylitis (an arthritis that affects the spine); and
- chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy.
Erelzi (etanercept-szzs) is “biosimilar” to Enbrel (etanercept), which as FDA approved in 1998. Both are biologic products derived from a living organism. A biosimilar is a biological product that gains FDA approval based on a showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety and effectiveness from the reference product, in addition to meeting other criteria specified by law.
“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”
“We continue to increase patient access to key treatment options by expanding our offering of biosimilars which helps to reduce costs within the healthcare system” said Carol Lynch, global head biopharmaceuticals, Sandoz – the maker of Erelzi.
“Sandoz is proud to have developed two of the three biosimilars that are currently FDA approved, which further demonstrates our commitment to US patients in a growing number of therapeutic areas. We are committed to bringing Erelzi to the US market as soon as possible.”