Press Release

Statement on First FDA Approval of A Biosimilar Product

PhRMA March 6, 2015

Washington, D.C. (March 6, 2015) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John J. Castellani released the following statement on the first approval by the Food and Drug Administration (FDA) of a biosimilar product:

“PhRMA supported enactment of the Biologics Price Competition and Innovation Act (BPCIA), which struck the appropriate balance between encouraging innovation and facilitating timely market entry of safe and effective biosimilar products.

PhRMA supports a science-based, transparent implementation of the BPCIA biosimilars pathway.  In order to meet these goals, we urge the FDA to promptly issue appropriate guidances on key outstanding issues including establishing interchangeability, labeling, and naming of biosimilars products, and to finalize outstanding guidances.”

About PhRMA

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested more than $550 billion in the search for new treatments and cures, including an estimated $51.1 billion in 2013 alone. 

Connect with PhRMA

For information on how innovative medicines save lives, please visit: