California’s Assembly and Senate have both overwhelmingly passed Senate Bill 598, legislation that creates a pathway for the substitution of interchangeable biologic medicines.

The biosimilars pathway is critical for China's biotechnology industry – and this is evident in the investment the government is making in the manufacture of biotech products

Biotechnology companies must have some certainty that they can protect their investment in the development of new breakthrough therapies for a substantial period of time.

A biologic is manufactured in a living system such as a microorganism, or plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules. Many biologics are produced using recombinant DNA technology.

Safety is a priority for the development of all medicines, but biologics raise safety considerations above and beyond those of chemical drugs.

In this presentation, BIO urges the Food and Drug Administration to prioritize patient safety and incentives for innovation at a public hearing on biosimilars.

On April 8, 2004, Genentech, Inc. filed a Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section 505(b)(2) of the Food, Drug and Cosmetic Act (FDCA) with respect to a biotechnology product that relies, directly or indirectly, on trade secret and confidential commercial data and information of an innovator.

The European Medicines Agency (EMEA), the European equivalent to the Food and Drug Administration (FDA), has implemented an approval scheme that specifically distinguishes between biosimilars (follow-on biologics) and generic drugs.

Biotechnology is all around us and is already a big part of our lives, providing breakthrough products and technologies to combat disease, reduce our environmental footprint, feed the hungry, and make useful products.

Danny Levine of the Burrill Report conducted a podcast with BIO President & CEO Jim Greenwood today on BIO's public priorities for 2010.

Biosimilars, also known as follow-on biologics, may eventually expand access and provide patients a more affordable alternative to innovative, lifesaving medicines. 

Myths abound regarding data exclusivity and the ability of an innovator to extend the period of data exclusivity as provided in the health care reform bill passed by the U.S. House of Representatives and legislation currently under consideration in the Senate.

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
July 31 2014
We applaud the World Health Organization (WHO) for recognizing this need by issuing “Biological Qualifier: An INN Proposal,” and we strongly support its intent to ensure that all biological medicines are distinguishable.