Monoclonal antibodies (MAbs) have become the most successful platform for targeted biotherapeutics, demonstrating high affi nity and specifi city for their target and considerably lower toxicity than small-molecule drugs. Technological advances in the development and production of MAbs have revealed that antibody fragments and other smaller, less complex proteins have the potential to overcome many disadvantages of MAbs, and researchers have begun to explore the therapeutic potential of peptides and nucleic acids as alternatives to MAbs. The small biotechnology companies that sprang up to commercialize these emerging technologies have benefi ted from a fl urry of recent licensing and development deals and acquisitions as Big Pharma begins to see the potential of MAb alternatives and hurries to get in on the action.

Get the Answers You Need to Shape Your Strategy

The biotechnology and pharmaceutical industries are turning to MAb alternatives as the next generation of targeted biotherapeutics. What advantages do small MAb alternatives offer over large MAbs? What disadvantages do these novel agents have? What choices are possible in the manufacture and formulation of MAb alternatives?
Because of the high price of biotherapeutic agents, health care payers, government, and patients are exerting pressure on companies to lower the prices of their drugs. How could MAb alternatives help companies respond to this pressure and remain profi table? How fast and cost-effectively can these agents be brought to market?
Although some MAb alternatives are already on the market, and despite growing industry confi dence in these novel technologies, the road ahead will not be easy. Why is small size not always better? What clinical disadvantages may be inherent in MAb alternatives? How will the anticipated regulatory guidance on approval of biogenerics in the United States affect the market for MAb alternatives?

Scope

Biotechnology overview: Biotherapeutics; monoclonal antibodies (MAbs); emerging MAb alternatives.
Industry overview: Biotech and Big Pharma companies; marketed MAb alternatives; molecules in development, by therapeutic area; industry deals and acquisitions, 2000-2007.
Production of MAb alternatives: Biological processes versus cell-free or chemical synthesis; formulation; reducing immunogenicity; cost; developmental timelines.

Executive Summary
- Strategic Considerations
- Stakeholder Implications
Introduction
The Structure of an Antibody
Improving on Monoclonal Antibodies
- Development
- Manufacturing
- Cost
- Competition and Royalty Stacking
- Delivery
- Immunogenicity
Industry Interest and Clinical Development
Remaining Challenges for MAb Alternatives
Appendix A. Types of Biologic Alternatives to Therapeutic Monoclonal Antibodies