Letter Supporting Florida House Bill 365; Pertaining to requirements for pharmacist to dispense substitute biological product

Feb 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.

CED: BIO's Comments in response to the Centers for Medicare and Medicaid Services’ (CMS) Draft Guidance for the Public, Industry, and CMS Staff Coverage with Evidence Development in the context of coverage decision

Jan 27 2013


BIO Principles on Patient Safety in the Substitution of Biologic Products

Jan 24 2013
To ensure transparency and communication between patients and their treatment teams, BIO believes that certain safeguards should guide substitution policies for interchangeable biologics under state law as well.

Statement in Support Of North Dakota S.B. 2190

Jan 24 2013
The policies outlined in Senate Bill 2190 align with all five of BIO’s Principles on Biologic Product Substitution and we therefore support its passage.

Statement in Opposition to North Dakota S. 2066

Jan 24 2013
BIO opposes the proposal to subject certain cancer therapies to prior authorization measures under Senate Bill 2066.

Data Standards: BIO Comments on Development of Prioritized Therapeutic Data

Jan 21 2013
BIO thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Development of Prioritized Therapeutic Data Standards (the Notice).”

IRB: BIO Comments on Draft Guidance for IRBs

Jan 21 2013
BIO thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for IRBs, Clinical Investigators, and Sponsors."

BIO Comments on India Guidelines for Examining Biotechnology Applications

Jan 17 2013
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments in response to the Controller General of Patents Designs and Trademarks in India on the "Draft Guidelines for Examination of Biotechnology Applications" hereafter referred to as "Draft Guidelines", or "Guidelines".

Statement in Support of Virginia H.B. 1422

Jan 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.

340B: BIO’s Comments to HRSA Regarding the Burden to Conduct 340B Audits

Dec 21 2012