WASHINGTON, April 16, 2012 /PRNewswire-USNewswire/ -- In response to the U.S. Food and Drug Administration's (FDA) draft guidance on the approval of biosimilar medicines, the Alliance for Safe Biologic Medicines (ASBM) submitted to the FDA that outlined recommended steps to ensure that patient safety is at the forefront of the biosimilars pathway.
While the FDA's proposed framework demonstrates the agency's thoughtful approach, ASBM stated in its comments that effective implementation of the biosimilars pathway must incorporate prudent measures, including:
Within its comment letter, the Alliance for Safe Biologic Medicines outlines clear, concrete, and achievable ways to manage risk and thereby prioritize patient safety.
Dr. Richard Dolinar, Chairman of the Alliance for Safe Biologic Medicines released the following statement as he submitted the coalition's comments to the docket:
On February 9, the FDA released draft guidance on the biosimilars approval pathway and requested written comments by April 16.
To speak to Dr. Dolinar or another member of the Alliance for Safe Biologic Medicines, please email .
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond. Visit us at .