BIO asks FDA for published guidance on biosimilar approval

The Biological Industry Organization (BIO) urged the FDA this week to develop better guidance on the approval of biosimilars. | Courtesy of BIO

The Biotechnology Industry Organization (BIO) urged the Food and Drug Administration on Wednesday to release its guidance on approving biosimilars and other issues.

In the statement, BIO wanted the FDA to “outline its approach to naming and labeling, and clarify its conditions for determining a biosimilar to be interchangeable with its reference biological.” The FDA's website describes a biosimilar as “a biological product similar to a U.S.-licensed reference biological product,” such as a vaccine, tissues or proteins, generally made from human or animal materials.

Jim Greenwood, president and CEO of BIO, said that while the FDA's advisory committee discussed the issues, more clarification is needed.

“This week’s advisory committee meetings facilitated important discussion of the scientific approach of reviewing biosimilar applications, and we encourage this positive momentum; however, we believe the appropriate way to develop policy on such a significant new approval pathway is through published guidance documents with the opportunity for public comment, rather than through single-application advisory committee meetings,” Greenwood said.

Greenwood said that for the last decade, BIO has pushed for a more “open, transparent and science-based dialogue regarding biosimilars.”

“We played a leading role in the effort to establish a pathway for the approval of biosimilars,” Greenwood said. “There are fundamental scientific considerations at the heart of the debate regarding biosimilars, and we welcome and encourage a dialogue among all stakeholders, as there are important implications for the appropriate use of all biologics, whether innovative or biosimilar.”