WASHINGTON, May 5, 2015 /PRNewswire/ -- A coalition of 11 leading companies involved in the development and manufacturing of biopharmaceuticals and "biosimilar" medicines today announced the formation of the Biosimilars Forum — the first nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States.
The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios, including: Actavis, Amgen, Boehringer Ingelheim, Coherus BioSciences, EMD Serono, Hospira, Merck, Pfizer, Samsung, Sandoz, and Teva. Many of these same companies provide branded biologic products, and together the Forum has extensive expertise and experience in the science, development, manufacturing, regulation, and clinical applications of biological medicines. The Forum will provide evidence-based information to educate and advocate for public policies and practices that encourage access, awareness, and adoption of biosimilars.
The recently elected officers of the Biosimilars Forum are president, Juliana Reed, vice president, global government affairs, Hospira, Inc.; vice president, Hillel Cohen, Ph.D., executive director, scientific affairs, Sandoz Biopharmaceuticals (a Novartis company); treasurer, Geoffrey Eich, executive director, external affairs, Amgen Biosimilars; and secretary, Stacie Phan, director, state government affairs and public policy, Boehringer Ingelheim.
According to the U.S. Food and Drug Administration (FDA), a biosimilar is approved based on a showing that it is highly similar to an FDA-approved biological medicine, known as a reference product, and has no clinically meaningful differences in terms of safety, purity, and effectiveness from the reference product. Using state-of-the-art technology and techniques, biosimilars are manufactured with the same excellence in standards as reference biologics.
Biosimilars are approved by the FDA based on the totality of evidence and on extensive comparisons to the reference product, including detailed analytical and biological assays, followed by nonclinical and pharmacokinetic/pharmacodynamic studies and then confirmation in a clinical setting.
The benefits attributed to the use of biosimilars are significant. In the European Union, where biosimilars have been approved for use since 2006, clinicians and patients have benefited from the use of millions of doses of biosimilar medicines. An analysis conducted by the Congressional Budget Office estimated that the introduction of biosimilars would reduce drug spending by roughly $25 billion over 10 years, saving the federal government nearly $6 billion.i
The Biosimilars Forum will be submitting a public statement about the need for appropriate coding for biosimilars to the Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Public Meeting on May 7, 2015.
i Source: Congressional Budget Office; Cost Estimate of the Biologics Price Competition and Innovation Act, June 25, 2008
SOURCE Biosimilars Forum