Amgen’s Senior Vice President of Research and Development Joe Miletich, M.D., Ph.D., urged members of a U.S. Food and Drug Administration (FDA) panel charged with implementing a pathway for biosimilars to establish approval standards that ensure patient safety and follow a science-based approach. Noting the complexities of biological products and the likely differences in products created from different living cells, Dr. Miletich outlined three key recommendations that the FDA should consider as it moves forward with implementation:

• Use well-designed clinical trials to establish biosimilarity;
• Ensure the product manufacturer and lot number is known for all administered biological; and
• Set scientific and practical criteria for interchangeability.