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Biosimilars: Facilitating Competition and Innovation in the Biological Products Marketplace

September 21, 2018

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South Dakota Governor Daugaard Signs Bill Facilitating Patient Access to Interchangeable Biologic Medicines

Washington, D.C. (February 09, 2018) – The Biotechnology Innovation Organization (BIO) and the South Dakota Biotech Association...

BIO Comments on FDA Draft Guidance ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin

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Biomilars: BIO Comments on FDA Draft Guidance Statistical Approaches to Evaluate Analytical Similarity

Re: Docket No. FDA-2017-D-5525: Statistical Approaches to Evaluate Analytical Similarity ...

BIO Applauds Signing of Food and Drug Administration Reauthorization Act (FDARA)

Enactment of FDA User Fee package important victory for patients, medical innovation

Biosimilars: BIO Submits Comments on Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II

Re: Docket No. FDA-2017-N-3199: Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II

BIO Applauds House Passage of Food and Drug Administration Reauthorization Act (FDARA)

Urges swift Senate vote to ensure continuity of critical FDA functions   Washington, DC (July 12, 2017) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement today regarding passage of the Food and Drug Administration Reauthorization Act (FDARA) by the U.S. House of Representatives:

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: