Biotechnology medicines generally are highly complex and feature large molecular mixtures derived from living organisms. In contrast, chemical drugs typically consist of smaller, synthesized, and chemically defined molecules. While the safety and effectiveness of a chemical drug can be established by the specification of its active ingredient, the safety and effectiveness of a biotech product can be impacted by the manner in which it is made, as well as by detailed in-process and final characterization.
Given the complexities surrounding the production of biotech drugs, many thought that the high-cost and high-science of biotech products would protect them from generic competition. But, according to Datamonitor, with more than half of the therapeutic proteins market — valued at $27 billion in 2001 — open to competition from generic alternatives by 2005, the appeal of more than $13.5 billion in biotechnology-based products will be a powerful lure for manufacturers of “biogenerics” to enter the market.
Despite the potential of the market, the uptake of biogenerics is expected to be slow because of the high cost of producing these therapeutics and the lengthy process of establishing an approval pathway. The approval process for biogenerics is expected to be established by 2006, and by 2010, industry analysts say a number of biogeneric companies will be in operation.
Patent Expiration Dates for Key Biologic Products
Major Players — Biogeneric Companies in 2002
BIO: Biogenerics Require Original Nonclinical and Clinical Data
Building Cross-Border Alliances
The Supply Chain Can Provide a Competitive Advantage
Therapeutic Protein Classes Most at Risk from Biogeneric Competition
The Management Team …
Carol Cherkis, Ph.D. Life Sciences Consultant, NewCap Partners Inc., Los Angeles; NewCap Partners is a private investment banking firm that focuses on the finance needs of middle-market companies. For more information, visit newcap.com.
Tillman U. Gerngross, Ph.D. Chief Scientific Officer, GlycoFi Inc., Lebanon, N.H.; GlycoFi is developing technology to address the biopharmaceutical industry’s need for a safer, faster, and more cost-effective therapeutic protein production. For more information, visit glycofi.com.
Nicole Lamble. Healthcare Strategy Analyst, Datamonitor Plc., London; Datamonitor, with U.S. offices in New York, is a business information company specializing in industry analysis for six industry sectors: automotive, consumer markets, energy, financial services, healthcare, and technology. For more information, visit datamonitor.com.
Stephen B. Maebius. Partner, Foley & Lardner, Washington, D.C.;Foley & Lardner, a provider of legal counsel to global companies, offers total solutions in the automotive, life sciences, financial services, insurance, healthcare, energy, and sports industries. For more information, visit foleylardner.com.
Paul J. Meyer Jr. Associate, Intellectual Property Practice, Squire, Sanders & Dempsey LLP, Los Angeles; Squire, Sanders & Dempsey is an international law firm. For more information, visit ssd.com.
Sidney Pestka, M.D. Chairman and Chief Scientific Officer, PBL Therapeutics, Piscataway, N.J.; PBL is developing ultra interferon-based cancer and antiviral pharmaceuticals and novel delivery systems. For more information, visit pblbio.com.
Audrey Phillips, Ph.D. Executive Director, Biopharmaceutical Public-Policy Planning, Johnson & Johnson, New Brunswick, N.J.; J&J is one of the world’s most broadly based manufacturers of healthcare products, as well as a provider of related services for the consumer, pharmaceutical, and medical-devices and diagnostics markets. For more information, visit jnj.com.
Ronald A. Rader. President, Biotechnology Information Institute, and author/publisher of Biopharma: Biopharmaceutical Products in the U.S. Market, Rockville, Md.; Biotechnology Information Institute offers consulting in biotech and pharmaceutical information resources development and information use and analysis; technological, competitive, market and
regulatory intelligence and assessments; Website development; information retrieval, to problem solving. For more information, visit bioinfo.com.
Patrick M. Schmidt. President and CEO of FFF Enterprises Inc., Temecula, Calif.; FFF Enterprises is a multidimensional healthcare company, delivering solutions in biopharmaceutical distribution, health-information management, and consumer health services, as well as supplying fractionated blood products, including albumin, intravenous immune globulin, and antihemophilic factors. For more information, visit fffenterprises.com.
Christopher J. Searcy, Pharm.D. VP, Corporate Development, Nektar Therapeutics, San Carlos, Calif.; Nektar provides a portfolio of leading drug-delivery technologies, including molecule engineering — advanced PEGylation, particle engineering, and
pulmonary delivery solutions that maximize the potential of large- and small-molecule drugs. For more information, visit nektar.com.
Michael Steiner. Worldwide Healthcare Practice Leader, Bain & Co., New York; Bain & Co., with headquarters in Boston, helps
industry leaders, emerging businesses, and private equity firms build ongoing value. For more information, visit bain.com.
David L. Webster, Ph.D. President, The Webster Consulting Group Inc., Lehigh Valley, Pa.; Webster Consulting provides management consulting services to the pharmaceutical, biotechnology, and medical industries. For more information, visit
Nanske Wood. President, Carbon Healthcare Communications, Wayne, N.J.; Carbon Healthcare, a unit of CommonHealth, is a professional advertising and promotion agency that provides biopharmaceutical and other emerging technology companies with ways of differentiating brands and building businesses. For more information, visit commonhealth.com.
Gillian R. Woollett, MA, D.Phil., VP, Science and Regulatory Affairs, Biotechnology Industry Organization, Washington, D.C.; BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. For more information, visit bio.org.
Daniel B. Yarosh, Ph.D. President and Chairman, Applied Genetics Inc. Dermatics, Freeport, N.Y.; AGI Dermatics is a private biopharmaceutical company focusing on DNA repair technology, dermatology technology, skin-cancer research, and the lifestyle enhancement market. For more information, visit agiderm.com.