Tuck Global Healthcare Conference

BIOGENERICS: An Emerging Force in Global Patient Health?

Conference Overview

The second annual Tuck Global Healthcare Conference held on April 11th focused on the emergence of biogenerics in the biopharmaceutical industry.  This is a hot topic in the U.S. as Congress is expected to pass legislation in the next couple years to create an abbreviated pathway for their approval. The biotechnology industry is bracing for the impact on their business.  The U.S. is years behind Europe, which established a legal and regulatory framework for biogenerics in 2004.

The FDA defines a biogeneric as a protein product which is intended to be a similar version or duplicate of an already approved or licensed protein product.  On the forefront of the biogenerics debate is the issue of their bioequivalency, which raises concerns regarding their safety and efficacy as well as determining the parameters for which these generic versions can be considered “the same” for therapeutic purposes.  The complex nature of biologics, as compared to small-molecules, makes this process much more difficult.  However, competition from biogenerics would benefit patients by enhancing accessibility of some biologics through decreasing the high costs of these drugs once they come off patent protection.  An industry analysis by Merrill Lynch predicts that they will initially be priced at 20 to 30 percent below the branded biologic but may eventually offer up to a 50 percent discount as more generic competition increases.

The event brought together leaders in the industry with some opposing viewpoints on the subject of biogenerics.  This generated lively discussions on the topics of biogeneric development, regulation, and legislation.  Dr. C. Everett Koop, former U.S. Surgeon General and founder of the C. Everett Koop Institute at Dartmouth, presented opening remarks.  The keynote speech delivered by Dr. Steven Gillis, Founder of Immunex Corporation and managing partner of ARCH Venture Partners, covered some of the complex issues and concerns surrounding biogenerics.  “As we look forward in time to the introduction of such products in the United States we need to realize that these are not simply generics, in the same sense of the word.”

A panel on biogenerics regulation focused on how the U.S. regulatory climate is likely to evolve and how it will impact patients, the healthcare system, and the global biotechnology industry.  James Greenwood, president and CEO of the Biotechnology Industry Organization, stated that the high costs of producing biologics will prevent discounts as significant as those seen with current generic drugs.  However, AARP Representative Anna Howard argued that the cost reduction to patients will be enough to impact them.

A second panel included discussion on the potential impact of biogenerics on patient health and costs to patients and payers.  Jim Roach from Momenta, a biotechnology company currently developing generic versions of biologics, agreed that biogenerics create unique challenges but argued that the FDA should have the discretion to approve these drugs on a case-by-case basis based on the research data generated, and that clinical trials should not be mandatory.  An opposing opinion by Andrew Hirsch, VP of Business Planning at Biogen Idec, was that since they won’t be identical to the branded product clinical trials should be required to ensure their safety and efficacy. 

The Healthcare Conference was organized by the Tuck Healthcare Club, Center for International Business, and the Healthcare Initiative..

Keynote Speaker Steven Gillis, Ph.D., Managing Partner, ARCH Venture Partners & Founder, Immunex Corporation