Biosimilar Approval is Step Toward Improving Access, Savings for Patients and System
Contact: Steve Arnoff 202.249.7113
WASHINGTON, DC (Aug. 31, 2016) — The Biosimilars Council, a division of GPhA, is very pleased that the Food and Drug Administration (FDA) has approved Sandoz Erelzi (etanercept-szzs) for all indications included in the reference product label, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA). This is the third biosimilar approval under the Biologics Price Competition and Innovation Act (BPCIA), an important step toward improving pharmaceutical competition and improving access and affordability in healthcare.
Statement by Christine Simmon, Executive Director, Biosimilars Council and Senior Vice President, Policy and Strategic Alliances, Generic Pharmaceutical Association
“Gaining product approval is just one part of system wide efforts to realize the promise of biosimilars. Regulators, policymakers and others must ensure that today’s decisions on reimbursement, interchangeability, and other issues foster tomorrow’s development of a robust biosimilars marketplace. These considerations will be critical so that biosimilars, safe, effective and more affordable alternatives to costly brand biologics, can deliver cost savings for patients and America’s healthcare system.
Through close collaboration with Congress, regulators, stakeholders, providers and other affordable medicine advocates, the Biosimilars Council will continue the shared effort to educate patients and professionals on the safety and efficacy of these medicines.”
These priorities will be front and center during the first Biosimilars Council Conference: Leading on Biosimilars, Sept. 7-8 in Bethesda, Maryland. Details and registration available here:
About the GPhA Biosimilars Council
The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.