Backgrounders

BIO’s Principles on Personalized Medicine

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. The EMEA recognized that "due to the complexity of biological/biotechnology-derived products the generic approach is scientifically not appropriate for these products." /1

Agriculture Biotechnology International Trade Fact Sheet

Regulatory Framework for Ensuring Animal Well-Being

Research institutions, companies and producer groups engaged in the growing field of animal biotechnology place animal well-being as a top priority. The humane care and use of animals in genomics, cloning and transgenics is guided by rigorous regulatory review and, in some instances, third party review. Regulatory Overview

Compliance Know-How: Workshop Offers Guidance

At BIO’s recent Focus on Compliance workshop, participants learned about the responsible use of plant biotechnology during R&D. Attendees from academia, government and corporations walked away from the event with a better understanding of how to comply with federal requirements during field trials of genetically engineered crops such as corn, cotton and soybeans.

Data Exclusivity and Biotech Competition: Separating Fact from Fiction

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. It’s time to set the record straight.

BIO Guidance for Genetically Engineered Animal Stewardship

BIO's Principles for Payment System Reform (PSR) Policies

BIO’s Principles on Universal Access to Health Care

BIO supports the following three principles, and believes that each is a vital step toward meaningful health care reform and providing a solution to the nation’s health care crisis. BIO believes that each principle is equally important, that they are inextricably intertwined, and that any meaningful health care reform proposal must address all three. Specifically, BIO believes:

BIO Principles on Follow-On Biologics

In order to ensure that new pioneer biotechnology products continue to reach patients and physicians, any statutory pathway for the approval of follow-on biologics must protect patient safety and preserve incentives to innovate.