PhRMA Statement on the FDA Approving Biosimilars

PhRMA Statement on the FDA Approving Biosimilars

Washington, D.C. (Nov. 3, 2010) – Pharmaceutical Research and Manufacturers of America (PhRMA) Associate Vice President for Scientific & Regulatory Affairs Marie A. Vodicka testified today at the Food and Drug Administration’s public hearing on federal implementation of the new biosimilars approval pathway.

Biologics have revolutionized healthcare, giving hope to patients. As of 2008, more than 300 biologics had been approved by the Food and Drug Administration (FDA) and 633 biotechnology medicines were in development, including more than 250 for various cancers.

Recently passed healthcare reform legislation, which passed with strong bipartisan support, for the first time empowers the FDA to approve biosimilars. As the FDA implements this important new pathway passed by Congress, Vodicka testified that the Agency should be guided by the following principles:

  • Ensure patient access to safe and effective biosimilars
  • Create a science-based pathway through an open, transparent process; and
  • Encourage innovation and enable additional competition.

In addition to these core principles, PhRMA’s testimony included detailed feedback in response to questions that the FDA posed about biosimilarity, interchangeability, pharmacovigilance, naming to promote patient safety and exclusivity.

Biosimilars and the 21st Century science that will drive the FDA’s implementation of this important new approval pathway underscore the need for the Agency to engage in ongoing dialogue through open, transparent processes with key stakeholders to develop needed guidances and regulations. PhRMA member companies, who lead the world in the search for new cures and treatments, welcome this week’s public meeting as the first of many opportunities to provide input on these important policies.


The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.

PhRMA Internet Address: www.phrma.org

For information on stories of hope and survival, visit: http://sharingmiracles.com/

For information on how innovative medicines save lives, visit: www.innovation.org

For information on the Partnership for Prescription Assistance, visit: www.pparx.org

For more information on public health emergencies, visit: www.rxresponse.org

For information on the danger of imported drugs, visit: www.buysafedrugs.info

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