Close

Testimony of Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization

What an honor it is to speak to you today on behalf of the Biotechnology Innovation Organization (BIO) about the Biosimilars User Fee Act reauthorization. This Committee planted the seed that has grown into multiple user fee programs that provide FDA with a significant portion of the resources it needs to ensure that patients have timely access to safe and effective new drugs and biologics, generic drugs, biosimilars, and medical devices. This Committee also tilled the ground and successfully produced, with an overwhelming bipartisan House vote, the legislation that established an FDA pathway for the approval of biosimilars – the Biologics Price Competition and Innovation Act (BPCIA). BIO was an early and strong supporter of this legislation to create a facilitated and balanced pathway for greater competition in the biologics marketplace.

BIO Position on Proposals to Provide for Export Manufacturing Exemption during Patent Term Restoration

Export manufacturing exemptions weaken the IP protections afforded by Supplementary Protection Certificate and Patent Term Restoration.

BIO Statement on Biosimilar User Fee Act Goals Letter

Washington, D.C. (September 16, 2016) – Biotechnology Innovation Organization (BIO) Senior Vice President for Science Policy Kay Holcombe released the following statement today regarding the Biosimilar User Fee Act (BsUFA) II goals letter:

Biosimilars: BIO Comments on FDA Draft Guidance Implementation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009

Re: Draft Guidance for Industry: Implementation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (Docket No. FDA-2015-D-4750 (March 14,...

Biosimilars: BIO Comments on FDA Draft Guidance Labeling for Biosimilar Products

Re: Draft Guidance for Industry: Labeling for Biosimilar Products (Docket No. FDA-2016-D-0643 (April 4, 2016)) ...

Arizona Governor Ducey Signs Bill Ensuring Patient Access to Interchangeable Biologic Medicines

The Biotechnology Innovation Organization (BIO) and Arizona BioIndustry Association (AZBio) commend Governor Doug Ducey for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines.

Kentucky Governor Bevin Signs Bill Ensuring Patient Access to Interchangeable Biologic Medicines

The Biotechnology Innovation Organization (BIO) and Kentucky Life Science Council (KLSC) commend Governor Matt Bevin for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines.

BIO & Kentucky Life Sciences Council Support Bill Ensuring Patient Access to Interchangeable Biologic Medicines

The Biotechnology Innovation Organization (BIO) andKentucky Life Sciences Council (KLSC) today voiced support for Kentucky Senate Bill 134, legislation that properly preserves patient and physician access to accurate prescription information, while promoting a competitive market for complex biologic medicines.

New Jersey Governor Christie Signs Bill Ensuring Patient Access to Interchangeable Biologic Medicines

Communication important for Patients and Physicians

BIO Submits Comments on Nonproprietary Naming of Biological Products

The Biotechnology Industry Organization (“BIO”) thanks the Food and Drug Administration (“FDA”) for the opportunity to submit comments on the Draft Guidance entitled “Nonproprietary Naming of Biological Products” (“Draft Guidance”).