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THOUSAND OAKS, Calif. Amgen's SVP research and development, Joe Miletich, urged members of a Food and Drug Administration panel to establish approval standards for biosimilars that ensure patient safety and follow a science-based approach.
“Put patients first and sound policy will follow,” Miletich said. “Amgen believes biosimilars have a meaningful role to play in the healthcare system. However, dissimilar — unlike generic drugs — are not identical to the innovative biological products.”
In his testimony, Miletich outlined three key recommendations:
- 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.
“The challenge with biosimilars is knowing which structural variations matter clinically and which do not. Many differences probably do not matter, while some differences are important,” Miletich said. “Minor changes in structure, formulation or impurities can have a significant impact on patients that cannot always be anticipated with analytical studies.”
In a company statement, Amgen noted that the experience with biosimilar applications in Europe demonstrated the need for clinical trials. “Approximately half of the biosimilars developed in Europe have had unexpected clinical outcomes at some point in their development. Clinical trials are an essential step in evaluating differences between medicines that analytical and pre-clinical studies indicate are similar. Equally important, we must ensure accountability through accurate tracking and tracing of all biological products,” the company stated.