Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), spent some quality time this afternoon answering questions from bloggers about follow-on biologics, patent reform, and FDARA/PDUFA legislation.
Mr. Greenwood said that follow-on biologics are a "critical, critical issue" for BIO. From BIO's perspective, the ideal bill would reflect and parallel the Hatch-Waxman Act. It would include 14 years of data exclusivity for innovators and would let physicians decide, on a case-by-case basis, whether to allow substitution of a brand-name biologic with a follow-on at the pharmacy.
Mr. Greenwood stated that 14 years of data exclusivity is needed in order to ensure a steady stream of new innovative drugs from the biotechnology industry. He explained that patent protection is generally adequate to protect small molecule drugs, which have, on average, 13.5 years of market exclusivity prior to generic entry. However, according to Mr. Greenwood, it is relatively easy for generic companies to design-around patents on biotech drugs and yet still take advantages of similarities for purposes of FDA approval. Because patent protection is insufficient, data exclusivity is key.
With regard to interchangeability, Mr. Greenwood said that the decision to allow substitution of an innovator biotech drug with a follow-on should be left to physicians for safety reasons. He said that such an arrangement would be preferable to giving the power to insurance companies.
In response to a question about reports that the generic drug industry is content to wait for passage of follow-on biologics legislation until the next Congress, when they might get a better deal, Mr. Greenwood emphasized that it is in the generic industry's interest as well for there to be a sufficient period of data exclusivity (without new drugs from the innovators, there will be no new drugs from the generics). He stated that BIO is "not going to take a bad deal in this Congress for fear of the outcome of the next presidential election." In the end, Mr. Greenwood predicted that the two sides would be able to come together before the next election, with a little prodding from Congress.