Biosimilars

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...

November 10, 2010

A biologic is manufactured in a living system such as a microorganism, or plant or animal...

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.