Health Care

For more than a decade, BIO has called for open, transparent, and science-based dialogue regarding biosimilars. More recently, we played a leading role in the effort to establish a pathway for the approval of biosimilars. Many of our members are global leaders in the development and commercialization of biosimilars.

The member companies of the Biotechnology Industry Organization (BIO) are committed to improving human health through the development of innovative therapies. We strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing our clinical trial data can help to advance such research, while reinforcing public confidence in the safety and efficacy of our medicines.

While BIO does not comment on individual companies or their decision-making in regards to compassionate use, as the trade association representing the industry, we can comment on the issue of early access to experimental products that have not yet received FDA approval.

California’s Assembly and Senate have both overwhelmingly passed Senate Bill 598, legislation that creates a pathway for the substitution of interchangeable biologic medicines.

Meta-analysis is used to inform a wide array of questions ranging from pharmaceutical safety to the relative effectiveness of different medical interventions. Meta-analysis also can be used to generate new hypotheses and reflect on the nature and possible causes of heterogeneity between studies.

S.391 and H.R. 475 update the existing excise tax to cover newly approved season flu vaccines

Dr. Richard Mohs, Distinguished Research Fellow, Eli Lilly discusses the importance of early diagnosis in Alzheimer's at the 2013 BIO International Convention.

At the 2013 BIO International Convention, Mundel discusses biotech start-ups and how biotech and technology can help meet needs in developing countries. The Global Burden of Disease Study 2010 (GBD 2010) is the largest ever systematic effort to describe the global distribution and causes of a wide array of major diseases, injuries, and health risk factors. The results show that infectious diseases, maternal and child illness, and malnutrition now cause fewer deaths and less illness than they did twenty years ago.

Keynote speaker Josh Sommer was recently named one of Forbes 30 Under 30 in Life Sciences and Healthcare. He discusses his rare cancer diagnosis while in college and his subsequent journey to become the Executive Director of The Chordoma Foundation. He also explains his search for information, insight and connections at the BIO International Convention.

Kathleen Ruddy, CEO of the St. Baldricks Foundation, the world's largest funder of childhood cancer research grants outside of the federal government explains the type of relationships they hope to develop at the 2013 BIO International Convention.

Seth Ginsberg, President of the Global Healthy Living Foundation discusess their healthy biologics initiative to improve the quality of life for people with chronic illnesses at the 2013 BIO International Convention.

From the 15th Annual BIO CEO & Investor Conference at the Waldorf Astoria Hotel in New York on February 12th, 2013.

Congress created the 340B program in 1992 to help uninsured indigent patients gain better access to prescription medicines. This white paper examines the history and original intent of the program as well as highlights key findings to help policymakers ensure that the 340B program meets its stated purpose and to provide a roadmap for next steps to be considered.

The biosimilars pathway is critical for China's biotechnology industry – and this is evident in the investment the government is making in the manufacture of biotech products

Letters, Testimony & Comments

April 17 2016
BIO member companies are committed to improving human health through the development of innovative therapies. We strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing our clinical trial data can help to advance such research, while reinforcing public confidence in the safety and efficacy of our medicines.
April 4 2016
The Biotechnology Innovation Organization (BIO) is pleased to submit comments in response to the Centers for Medicare & Medicaid Services’ (CMS’s) Final Rule with Comment entitled Medicaid Program; Covered Outpatient Drugs Final Rule with Comment Period (the “FC”).1 As directed by the Agency, the scope of our comments is limited to the single topic open for public comment: “The definition and identification of line extension drugs.”2 
March 13 2016
BIO strongly supports efforts by the Agency, such as the Pilot COA Compendium and recent updates to the FDA’s drug development tool (DDT) qualification website, to promote the efficient development and use of COAs and other DDTs for drug development and regulatory decision-making. We believe that the COA Compendium is a good step in providing information to the public about COAs in development and use, providing a level of transparency and increasing awareness of efforts towards patient-focused drug development and COA information.
February 16 2016
BIO supports FDA’s assertion that “it is critical for sponsors to detect and report, as early as possible, serious and unexpected suspected adverse reactions and clinically important increased rates of previously recognized serious adverse reactions,” and we appreciate the publication of this Draft Guidance to aid Sponsors in this responsibility. However, we are concerned about the prescriptive nature of this Draft Guidance and its emphasis on the Safety Assessment Committee (SAC). We are also concerned that FDA may not fully appreciate the time and resources required of Sponsors to implement the recommendations within the Draft Guidance.
February 8 2016
BIO strongly supports the Prescription Drug User Fee Act (PDUFA 5) program to enhance FDA-Sponsor communication, which is based on FDA’s stated philosophy that “timely interactive communication with Sponsors during drug development is a core activity to help achieve our mission to facilitate the conduct of efficient and effective drug development programs, which can enhance public health by making new safe and effective drugs available to the American public in a timely manner.” BIO applauds FDA’s effort to give IND Sponsors and FDA review staff best practices and procedures for timely, transparent, and effective communications during drug development through this Draft Guidance.

Press Releases

April 25 2016
Washington, D.C. (April 25, 2016) – The Biotechnology Innovation Organization (BIO) issued the following statement today regarding the Campaign for Sustainable Rx Pricing’s policy proposals on prescription drug prices:
April 6 2016
Washington, D.C. (April 6, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement regarding today’s Senate HELP Committee mark-up of legislation as part of the Senate biomedical innovation initiative:
March 30 2016
Washington, D.C. (March 30, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement today regarding the American College of Physicians’ policy paper on prescription drugs:
March 17 2016
Washington, D.C. (March 17, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement regarding the introduction today by Senators Alexander and Murray of the FDA and NIH Workforce Authorities Modernization Act: