FDA News

FDA approves biosimilar to Enbrel

The FDA has approved Erelzi for all indications included in the reference product label, including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.

Erelzi is a biosimilar to Enbrel (etanercept, Amgen). Erelzi (etanercept-szzs, Sandoz) is the second biosimilar from Sandoz approved in the United States through the FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.

“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said 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 approval follows a 20-0 vote by the FDA’s Arthritis Advisory Committee in July to recommend use in all indications of the reference product. According to the FDA release, the approval was based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Erelzi is biosimilar to Enbrel.

Erelzi is administered by injection for the treatment of moderate to severe rheumatoid arthritis, either as a stand-alone therapy or in combination with methotrexate (MTX); moderate to severe polyarticular juvenile idiopathic arthritis in patients aged 2 years 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; and chronic moderate to severe plaque psoriasis in patients aged 18 years or older who are candidates for systemic therapy or phototherapy.

“We continue to increase patient access to key treatment options by expanding our offering of biosimilars which helps to reduce costs within the health care system,” Carol Lynch, global head for biopharmaceuticals at Sandoz, said in a company press release. “Sandoz is proud to have developed two of the three biosimilars that are currently FDA approved, which further demonstrates our commitment to U.S. patients in a growing number of therapeutic areas. We are committed to bringing Erelzi to the U.S. market as soon as possible.”

Reference:

www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm

www.sandoz.com

The FDA has approved Erelzi for all indications included in the reference product label, including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.

Erelzi is a biosimilar to Enbrel (etanercept, Amgen). Erelzi (etanercept-szzs, Sandoz) is the second biosimilar from Sandoz approved in the United States through the FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.

“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said 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 approval follows a 20-0 vote by the FDA’s Arthritis Advisory Committee in July to recommend use in all indications of the reference product. According to the FDA release, the approval was based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Erelzi is biosimilar to Enbrel.

Erelzi is administered by injection for the treatment of moderate to severe rheumatoid arthritis, either as a stand-alone therapy or in combination with methotrexate (MTX); moderate to severe polyarticular juvenile idiopathic arthritis in patients aged 2 years 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; and chronic moderate to severe plaque psoriasis in patients aged 18 years or older who are candidates for systemic therapy or phototherapy.

“We continue to increase patient access to key treatment options by expanding our offering of biosimilars which helps to reduce costs within the health care system,” Carol Lynch, global head for biopharmaceuticals at Sandoz, said in a company press release. “Sandoz is proud to have developed two of the three biosimilars that are currently FDA approved, which further demonstrates our commitment to U.S. patients in a growing number of therapeutic areas. We are committed to bringing Erelzi to the U.S. market as soon as possible.”

Reference:

www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm

www.sandoz.com