Biosimilars

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Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section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.

January 31 2014
The Biotechnology Industry Organization (BIO) respectfully submits these comments in response to the Generic Pharmaceutical Association (GPhA) Citizen Petition requesting the Food and Drug Administration (FDA) to “implement its INN naming policy equally to all biologics” and to require “all biologics approved under the Section 351(k) pathway…share the same INN [International Nonproprietary Name] as the RPP [reference protein product]” (the GPhA Petition).
November 27 2013
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the revised “Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005 Rev. 1).” BIO commends EMA on the update of this Draft Guideline, which provides an important international precedent for the development and regulation of biosimilar biological medicinal products.
October 31 2013
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the revised “Guideline on Similar Biological Medicinal Products (CHMP/437/04 Rev1).” BIO commends EMA on the update of this Draft Guideline, which provides an important international precedent for the regulation of biosimilar biological medicinal products.
October 16 2013
BIO appreciates this fourth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory Requirements for the Registry of Medicines of Biological Origin and we refer you to our previous comments filed to the Colombian Ministry of Health on April 24th 2012, June 12th 2012 and February 21st 2013 for background about BIO and its interest in this Decree. 
July 8 2013
As the Mexican government looks to establish a pathway to market for biosimilar biological products, BIO offers the following important considerations to ensure patient safety, as well as continued innovation in the life sciences industry.
March 25 2014
The Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF) commend Indiana Governor Mike Pence for signing legislation today designed to create a pathway for the substitution of interchangeable biologic medicines.
February 26 2014
Transparent communication important for Patients and Physicians
January 30 2014
Patients Should Be Informed if Doctor's Prescription Changed
April 17 2012
The Biotechnology Industry Organization (BIO) submitted comments yesterday to the U.S. Food and Drug Administration (FDA) on three draft guidance documents on biosimilar products.
March 29 2012
Sara Radcliffe, Executive Vice President of Health at the Biotechnology Industry Organization (BIO), testified today on biosimilar user fees (BsUFA) and the Prescription Drug User Fee Act (PDUFA) before the Senate Health, Education, Labor and Pensions Committee.