By Donald Zuhn --
Earlier today, Patent Docs participated in a conference call with Jim Greenwood (at right), the President and CEO of the Biotechnology Industry Organization (BIO). Mr. Greenwood, who represented Pennsylvania's Eighth District in the U.S. House of Representatives from January 1993 through January 2005 prior to his BIO appointment, had invited the press and a handful of biotech and pharma bloggers to participate in the conference call, where he provided a briefing on the prospects for passage of biologics legislation and patent reform legislation in this Congress. Mr. Greenwood expressed the hope, in view of the time and effort expended in "educating" legislators to the intricacies of these issues, that progress can be made with respect to both pieces of legislation in order to avoid having to retrace steps were the legislation left to the next Congress and administration.
With respect to follow-on biologics, Mr. Greenwood quickly dispelled any notion that BIO or its membership stood in opposition to the passage of follow-on biologics legislation, stating that "Congress ought to act," and noting that BIO had been actively encouraging both houses of Congress to report a bill. Mr. Greenwood contended that securing passage of a suitable follow-on biologics bill was important because biologics innovators could have difficulty fending off generics with just their patents alone, which might provide no protection, or only weak protection, against biosimilars. According to Mr. Greenwood, BIO found H.R. 1956, which was introduced by Rep. Jay Inslee (D-WA; at left) last April, to be an acceptable bill. Mr. Greenwood noted that 
another potentially suitable bill could soon be introduced by Rep. Anna Eshoo (D-CA; at right). Rep. Eshoo's bill, which is said to be a compromise between "generics-friendly" legislation written by Rep. Henry Waxman (D-CA) and Rep. Inslee's "brand-friendly" legislation, recently picked up the support of Rep. Joe Barton (R-TX), the top Republican on the House Energy & Commerce Committee (see "Barton Backs Eshoo's Biosimilars Plan").
Whichever bill BIO ultimately backs, Mr. Greenwood stressed the importance of striking a fair balance between the demands of the brand names and those of the generics, stating that "if you give companies incentives to create new drugs, they will." Mr. Greenwood acknowledged that the sticking point with regard to passage of follow-on biologics legislation would continue to be the period of data exclusivity. When asked whether BIO would be satisfied with splitting the difference between a 12-year exclusivity period backed by the generics industry and the 14-year period of Rep. Inslee's bill, Mr. Greenwood expressed skepticism that generics would support a 12-year period, stating that "if the generics were at 12, we would have a Valentine's Day love fest."
In addition to providing Mr. Greenwood with an opportunity to once again address patent reform and follow-on biologics legislation (Patent Docs readers will recall that Mr. Greenwood had addressed both topics in a conference call last September; see "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform"), the session with the media also provided BIO with an opportunity to present a number of its position papers on the topics. In a paper entitled "BIO Principles on Follow-On Biologics," the organization outlined principles that Congress should recognize when crafting a follow-on biologics bill. Among the key principles that BIO lists are the following:
• Ensure patient safety by mandating that follow-on biologics approval be based on the same rigorous standards of safety, purity, and potency that are applied by Food and Drug Administration (FDA) to the approval of innovator drugs, and assigning follow-on biologics a non-proprietary name that is readily distinguishable from that of the innovator drug.
• Because biologics are more complex than small molecule drugs, follow-on biologics legislation should recognize the scientific differences between the two classes of molecules. For example, small manufacturing differences between a follow-on biologic and innovator drug can, in contrast with small molecule drugs, result in significant safety or effectiveness differences.
• Preserve incentives for innovation by providing "substantial" non-patent data exclusivity, during which time follow-on biologics manufacturers could not rely on the FDA's prior approval of innovator biologics to support approval of the follow-on manufacturer's own products. According to the BIO position paper, such data exclusivity is necessary because of the biologics industry's "heavy dependence on access to significant amounts of high-cost public and private investment capital, and the high risks and costs involved in the development of new biologic medicines."
In a companion piece to this article, Kevin Noonan discussed Mr. Greenwood's comments on patent reform legislation.
For additional information on this and other related topics, please see
• "Insmed Announces National Awareness Campaign Regarding Follow-on Biologics," February 13, 2008
• "Millennium Pharmaceuticals Spent $1.28 Million on Lobbying in 2007," February 8, 2008
• "Biologics Legislation Faces Unresolved Issues," December 28, 2007
• "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007
• "Biotechs Facing New Challenges," August 13, 2007
• "Three New Biosimilars Pass EMEA Test," July 26, 2007
• "European Medicines Agency Releases Paper on Biosmiliar Medicines," July 23, 2007
• "Senate Committee Passes Biologics Legislation," July 5, 2007
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