Blog
ASBM Submits Comments to FDA
April 19th, 2012
The Alliance for Safe Biologic Medicines (ASBM) submitted comments to the FDA outlining recommended steps to ensure that patient safety is at the forefront of the biosimilars pathway. Read the ASBM Comments.
A Safe Pathway to Biosimilars
April 11th, 2012
By Dr. Richard Dolinar
Chairman of the Alliance for Safe Biologic Medicines
(Published April 5, 2012)
Excerpt:
Recently, the FDA issued a series of draft guidance documents that outlined the approach the agency would take to make biosimilars available for patients in the U.S. While the guidance documents emphasized that the FDA was rightly focused on safety, they failed to provide clarity around what measuring stick the FDA will use to determine if a product is similar. We know that clinical trials could be used to prove that they are trustworthy.
But we need to find the questions that must be answered by manufacturers of biosimilars to make doctors rest easy when prescribing them. Ultimately, we want to have the same confidence in biosimilars that we have in biologics, but that can only happen if the FDA is clear and specific about the standards to which it is holding biosimilar manufacturers and if the data is available to the public.
European Union provides a good example of effective biosimilars pathway
December 14th, 2010
Biologic drugs can treat a variety of illnesses—including cancer and certain types of arthritis—imore effectively than traditional, chemical based products. For this reason, the medical community is excited about the potential of these so called “miracle drugs.”
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FDA must establish safe approval pathway for biosimilar drugs
December 14th, 2010
Biologic drugs are often referred to as ”miracle drugs“ for good reason—they can often treat serious illnesses such as cancer, rheumatoid arthritis, and multiple sclerosis far more effectively than the traditional chemical drugs that preceded them.
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