Press Releases
February 15 2012
February 9 2012
November 3 2010
Letters, Testimony & Comments
March 21 2013
BIO commends the Government of Peru for its endeavor to create a pathway for the approval of biological and biotechnological products. Peru is a growing market for biotechnology products and with the implementation of the US-Peru TPA, it promises to become an even bigger market.
February 22 2013
BIO commends the government of Colombia for taking steps towards developing regulatory requirements for the registry of medicines of biological origin. Many elements of the third draft appear to have addressed BIO's previous comments with respect to clarity of structure and definitions of terms, as well as expectations for data requirements.
February 1 2013
BIO supports passage of Florida House Bill 365, which provides requirements for pharmacist to dispense substitute biological products that are determined to be interchangeable for prescribed biological product.
January 10 2013
In December 2012, Virginia House Delegate John M. O'Bannon, III introduced the Interchangeable biosimilar biological products bill (H.B. 1422). This proposed legislation seeks to permit pharmacists to dispense a biosimilar drug that has been licensed by the U.S. Food and Drug Administration as interchangeable with a prescribed biological product unless the prescriber indicates such substitution is not authorized or the patient insists on dispensing of the prescribed biological product.
November 30 2012
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