Biotechnology Industry Organization (BIO) President and CEO Jim
Greenwood issued the following statement regarding the newly released
U.S. Food and Drug Administration (FDA) guidance for the review and
approval of biosimilars:
"Today the FDA announced specific guidance for the review and approval
of biosimilars, medicines that are similar to, but not exact replicas
of, innovator biologics. Biologic therapies save, extend and improve the
quality of life for patients living with debilitating diseases including
cancer, HIV/AIDS, multiple sclerosis, and a host of rare and orphan
diseases.
"We are pleased that the FDA has developed these important guidances,
marking another important step forward on the pathway to biosimilars. We
look forward to reviewing the drafts in detail to ensure that they
comply with our key principles, particularly ensuring patient safety,
recognizing scientific differences between drugs and biologics,
maintaining the physician-patient relationship and preserving incentives
for innovation.
"In addition, BIO believes that careful post-market monitoring of the
safety of a biologic, whether an innovator or biosimilar, is critical
and should be funded by user fees. BIO supports timely authorization of
the biosimilars user fee agreement, which will provide FDA with the
resources and capacity to evaluate biosimilars products and support
biosimilar post-market safety activities, while continuing to prioritize
the review of innovative new medicines for unmet medical needs.
"BIO encourages the FDA not to delay approval for new innovator
biologics as it undertakes a pathway for approving biosimilars. The
needs of patients awaiting innovative cures and therapies for unmet
medical needs must remain paramount.
"BIO looks forward to continuing to work with the FDA on finalizing the
pathway for biosimilars."
About BIO
BIO represents more than 1,100 biotechnology companies, academic
institutions, state biotechnology centers and related organizations
across the United States and in more than 30 other nations. BIO members
are involved in the research and development of innovative healthcare,
agricultural, industrial and environmental biotechnology products. BIO
also produces the BIO International Convention, the world's largest
gathering of the biotechnology industry, along with industry-leading
investor and partnering meetings held around the world. BIO produces BIOtech
Now, an online portal and monthly newsletter chronicling
"innovations transforming our world." Subscribe
to BIOtech Now.
Upcoming BIO Events
BIO
CEO & Investor Conference
February 13-14, 2012
New
York, NY
BIO
IP Counsels Committee Conference
April 16 – 18, 2012
Austin,
TX
World
Congress on Industrial Biotechnology & Bioprocessing
April
29-May 2, 2012
Orlando, FL
2012
BIO International Convention
June 18-21, 2012
Boston, MA
BIO
Business Forum
June 18 – 21, 2012
Boston, MA
