Biosimilars: Facilitating Competition and Innovation in the Biological Products Marketplace

September 21, 2018

Re: Docket No. FDA-2018-N-2689-0001: Facilitating Competition and Innovation in the Biological Products Marketplace; Public Hearing; Request for Comment

Dear Sir/Madam:

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to participate in FDA’s September 4, 2018 Public Hearing and to submit comments to the Docket on Facilitating Competition and Innovation in the Biological Products Marketplace, as this is an important topic for BIO and its members.

BIO is the world's largest biotechnology trade association, representing 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. 

Of particular relevance to the Hearing, BIO’s membership includes all of the leading companies on the cutting-edge of biological product innovation, many of whom are also actively involved in developing and bringing to market biosimilars and interchangeable biological products. As the Federal Trade Commission predicted in its 2009 report[1] regarding the future development of the biosimilar marketplace in the United States, the complexity of developing and administering such products means that this marketplace is likely to take on the characteristics of brand-to-brand competition rather than the generic competition we see under the Hatch-Waxman Act (HWA) today. This is an important and fundamental consideration to keep in mind as we discuss how to best foster a robust competitive marketplace for biological products.       

Because of our commitment to improving patient access to safe, effective, and affordable therapeutic choices, BIO was a leader in persuading Congress to create a statutory pathway for the approval of biosimilar and interchangeable biological products, known as the Biologics Price Competition and Innovation Act (BPCIA). BIO unequivocally believes that safe and effective biosimilars and interchangeable products are good for patients and good for the public health. As FDA states on its website, “When patients are prescribed a biological product, biosimilar and interchangeable products can offer additional treatment options, potentially lowering health care costs.”[2]