Biosimilars Forum Issues Statement Regarding House Energy & Commerce, Subcommittee on Health Biosimilars Hearing, Launch of New Biosimilars Education Initiative

Washington, DC, February 4, 2016 – The Biosimilars Forum – the nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States – issued the following statement about the Biosimilars hearing before the House Energy and Commerce, Subcommittee on Health and the launch of a new biosimilars education initiative.

“We welcome the biosimilars hearing before the House Energy and Commerce, Subcommittee on Health. Many House and Senate Members and countless stakeholders have now voiced their concerns and opposition to the Centers for Medicare and Medicaid Services (CMS) policy that has multiple biosimilars being grouped and issued the same J-code for Medicare reimbursement purposes. We continue to make the case that this reimbursement policy could result in fewer biosimilars being introduced in the United States, and ultimately in fewer treatment options for health care professionals and patients,” said Michael Werner, Biosimilars Forum policy advisor.

“This approach is inconsistent with not only how the Food and Drug Administration (“FDA”) classifies biosimilars, but also how CMS itself defines biosimilar products under Medicaid and Medicare Part D. The CMS’s proposed payment methodology is likely to dramatically reduce investment in, and the subsequent availability of, biosimilar products, which is clearly against the intent of Congress in providing for a vibrant U.S. biosimilars market,” Werner concluded.

The timing of this hearing is important as the Biosimilars Forum just launched the Partnership for Biosimilars Education and Access, with the focus on raising awareness and encouraging access to biosimilars in the United States. In addition, the FDA will be convening an advisory committee on a biosimilar application on Tuesday, February 9, 2016.

Organizations wishing to collaborate with the Biosimilars Forum on the Partnership for Biosimilars Education initiative, are encouraged to contact the Biosimilars Forum at, 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.

To learn more about biosimilars, the Forum, and how to get involved, visit or go to @USbiosimilars to follow related conversations and join the dialogue.

Aimee Steel

Lynn Blenkhorn