Statement in Response to FTC Report on Biosimilars

THOUSAND OAKS, Calif.–June 10, 2009–As a biotechnology pioneer committed to developing first-in-class medicines that treat serious illnesses and unmet health needs, Amgen believes that an abbreviated biosimilar approval pathway must not discourage the development of groundbreaking new treatments for serious diseases.

We are pleased that the FTC report accepts that biosimilars are not identical to the innovative biologic products they attempt to copy and defers to the FDA on the scientific aspects associated with biosimilars, including the necessity of clinical testing pre-approval and the fact that interchangeability of biosimilars is unlikely under current science.  However, we are disappointed that the report does not adequately consider one the most critical elements of the biosimilars debate—namely the importance not only of access to lower cost versions of existing medicines, but also the development of breakthrough therapies for diseases like cancer, Alzheimer’s and multiple sclerosis. Without a fair and sustainable cycle of investment and returns in innovative R&D, biotech discovery will be stifled – diminishing the hopes of patients facing life-threatening diseases without effective treatment.

On the period of data exclusivity, the FTC report reaches a different conclusion than developed countries around the globe, including those in Europe (which grants 11 years for biologics) and Canada, and expert economists who have studied the cost of drug development and have made accurate and current calculations of 12-16 years for innovators to recoup aggregate development costs.

We look forward to working with Congress on legislation which strikes a necessary balance in allowing access to safe and effective biosimilar medicines for patients, and providing fair incentives for the discovery of new medicines.