The Biotechnology Industry Organization (BIO) is urging the US Food and Drug Administration to release final guidance on processes and scientific criteria for the approval of biosimilars, outline its approach to naming and labeling, and clarify its conditions for determining a biosimilar to be interchangeable with its reference biological. BIO issues the statement on January 7, 2015 following the recommendation of the FDA's Oncologic Drugs Advisory Committee (ODAC) to recommend the approval of Sandoz's biosimilar for filgrastim.
“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,” said Jim Greenwood, BIO’s president and CEO, in the BIO statement.
“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 to establish a pathway for the approval of biosimilars. 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,” said Greenwood.
Meanwhile, the Generic Pharmaceutical Association (GPhA) issued its support for the FDA considering Sandoz's application for a biosimilar filgrastim, "The meeting on filgrastim, a Sandoz biosimilar under agency review, is historic not only for FDA as it considers the first approval of a biosimilar product but also for patients in America awaiting access to safe, affordable versions of biologics," said GPhA in a statement. "GPhA and its member companies applaud the FDA for advancing this process, bringing us another step closer to having biosimilars in the United States. We look forward to working with members of the supply chain, stakeholders and patients to expedite access to safe, effective and more affordable biosimilars.”
Source: BIO and GPhA