Biosimilars

December 1, 2014

For more than a decade, BIO has called for open, transparent, and science-based dialogue...

September 24, 2013

California’s Assembly and Senate have both overwhelmingly passed...

February 1, 2013

The biosimilars pathway is critical for China's biotechnology industry – and this is...

December 7, 2012

Biotechnology companies must have some certainty that they can protect their investment in the...

Letters, Testimony & Comments

October 26 2015
The Biotechnology Industry Organization (“BIO”) thanks the Food and Drug Administration (“FDA”) for the opportunity to submit comments on the Draft Guidance entitled “Nonproprietary Naming of Biological Products” (“Draft Guidance”).
July 12 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (May 2015)” (“Q&A Draft Guidance”).
April 23 2015
BIO has filed a friend of the court brief at the Federal Circuit in the Amgen v. Sandoz case.
October 14 2014
The Biotechnology Industry Organization (BIO) appreciates this fifth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory Requirements for the Registry of Medicines of Biological Origin.
October 5 2014
The Biotechnology Industry Organization (“BIO”) thanks the Food and Drug Administration (“FDA”) for the opportunity to submit comments on the above-referenced Draft Guidance for Industry: Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (August 2014) (“Exclusivity Draft Guidance” or “Draft Guidance”).

Press Releases

November 10 2015
Communication important for Patients and Physicians
October 8 2015
Communication Important for Patients and Physicians
March 6 2015
Washington, D.C. (March 6, 2015) – The Biotechnology Industry Organization (BIO) issued the following statement today regarding the approval by the Food and Drug Administration (FDA) of the first biosimilar product under the pathway created by the Biologics Price Competition and Innovation Act (BPCIA).
January 7 2015
Biosimilars raise novel and complex questions of science and law that require updated legal and regulatory frameworks