Biosimilars Forum Launches “Partnership for Biosimilars Education and Access”
New Initiative Seeks to Encourage Awareness and Access to Biosimilars
Washington, DC, February 1, 2016 – The Biosimilars Forum – the nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States – today announced the launch of a new biosimilars education initiative. The initiative, Partnership for Biosimilars Education and Access, will focus on raising awareness and encouraging access to biosimilars in the United States. In support of the initiative launch, the Forum today released two educational guides designed for health care professionals, media, and patient advocacy organizations to learn more about biosimilars.
Leveraging the Forum’s vast expertise on the science, development, manufacturing, regulation, and clinical applications of biological medicines and biosimilars, the education tools provide detailed background, insights, FAQs, and resources on biosimilars that can be used by multiple stakeholders. The information is free and available at biosimilarsforum.org.
“We know that some of the most difficult diseases that afflict people in the U.S. are best treated with biological medicines,” said Juliana Reed, president of the Biosimilars Forum. “The introduction of biosimilars is anticipated to help drive lower cost burdens for the U.S. health care system. It will also help expand earlier, more consistent access to these important medicines for patients with cancer, anemia, inflammatory bowel disease, multiple sclerosis, rheumatoid arthritis, psoriasis, and Crohn’s and other inflammatory bowel diseases.”
The U.S. Food and Drug Administration (FDA) approved the first biosimilar in 2015, and more than 50 biosimilars are in development in the U.S. 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 and effectiveness from the reference product. 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.
Organizations wishing to collaborate with the Biosimilars Forum on the Partnership for Biosimilars Education and Access initiative are encouraged to contact the Biosimilars Forum at http://www.biosimilarsforum.org/contact-us, or via Twitter @USbiosimilars.
About the Biosimilars Forum
The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios.