WASHINGTON--(BUSINESS WIRE)--The Biotechnology Industry Organization (BIO) issued the following statement today regarding the approval by the Food and Drug Administration (FDA) of the first biosimilar product under the pathway created by the Biologics Price Competition and Innovation Act (BPCIA).
The following statement may be attributed to BIO President and CEO Jim Greenwood:
"For more than a decade, BIO has called for open, transparent and science-based dialogue regarding biosimilars and we played a leading role in the effort, through the BPCIA, to establish a pathway for the approval of biosimilars. We continue to support the BPCIA, and the approval of biosimilars based on appropriate rigorous science.
"It is unfortunate that the lack of publicly available naming guidance resulted in FDA's assignment of a 'placeholder' name for the approved biosimilar. We continue to urge the Administration to issue guidance promptly on this crucial matter, as well as on other biosimilar related issues. The publication of draft guidance for stakeholder comment, followed by final guidance that has taken account of that comment, is the best way to ensure that patient safety is prioritized as the FDA moves forward with implementation of this important law."
BIO is the world's largest trade association representing 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. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.
Upcoming BIO Events
March 9-11, 2015
Asia International Conference
March 24-25, 2015
May 19-20, 2015
June 15-18, 2015
Congress on Industrial Biotechnology
July 19-22, 2015