Toward Effective Competition in Biologics

In a previous article—Follow-On Biologics Are Set Up to Fail—I explained why biologics markets do not and probably will not have enough competition. This is not to say that these markets lack competition altogether. Rather, the legal and commercial landscape is such that competition in biologics will remain scant and inadequate for lowering prices of biologics similarly to the price drops seen in generic drugs. This reality is not a result of one or two cardinal reasons, but many. Accordingly, if lowering the price of biologics is the goal and competition is the means by which we seek to achieve this goal, then there does not seem to be a “quick fix” to address all of the many impediments to competition that plague biologics markets. Yet, baring significant technological developments, meaningful competition in biologics markets is not going to be possible without making biologics’ manufacturing information available to follow-on manufacturers. As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics in general and interchangeable biosimilars in particular is and will continue to be difficult and expensive, if not outright impossible. Yet, it has long been the position of the pharmaceutical industry (Industry) that biologics manufacturing information is proprietary and, thus, may not be shared. Both Congress and the FDA have subscribed to the Industry’s position and kept regulatory filings submitted by biologics manufacturers, including manufacturing information, unavailable to the public. This article examines the position that manufacturing information is proprietary and must remain confidential in light of the similar legal and commercial circumstances in the area of pesticides. The article reviews the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as it is administered by the Environmental Protection Agency (EPA) and then examines its applicability to the area of biologics. The article proceeds with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets