NHF has developed a policy position on the U.S. Food and Drug Administration (FDA) approval process for biosimilars. Biosimilars and follow-on biologics are analogous to generic pharmaceuticals, but for biologics not drugs. Clotting factors are classified as biologics, which are therapies derived from human or animal proteins. Since biologics are more complex than drugs, a biosimilar is not identical to the innovator product like generics are for drugs. Currently, there is no regulatory pathway at FDA for biosimilars to be approved. Amendments to the health reform legislation in both the House and the Senate include provisions to create this pathway.
NHF supports the creation of a regulatory pathway at FDA to approve biosimilars, but believes there must be protections for the end users of the products. NHF has not endorsed any of the bills, but has communicated key elements to be included in any biosimilars legislation. These elements relate to clinical trials, immunogenicity (the extent to which the biosimilar will cause the same biological response as the innovator), interchangeability (whether insurance companies can automatically switch the patient to the biosimilar product instead of the innovator), resources for the FDA, and the period of exclusivity offered to innovator products. Our primary concern is ensuring the safety and efficacy of biosimilar products.
In early August, NHF sent letters were sent to Congressional leaders advocating for these priorities on behalf of the bleeding disorders community. NHF policy position letters were sent to House Energy and Commerce Chairman Henry Waxman (D-CA), House Energy and Commerce Ranking Member Joe Barton (R-TX), Congresswoman Anna Eshoo (D-CA, whose biosimilars legislation was included in the House health reform bill), Senate HELP Committee Chairman Ted Kennedy (D-MA), and Senate HELP Ranking Member Mike Enzi (R-WY).
Click here to read the letter.