By James DeGiulio --
Last week, the Food and Drug Administration began gathering information on how to implement the new biosimilar approval pathway of the Biologics Price Competition and Innovation Act (see "FDA Planning to Hold Public Hearings on Biosimilar Approval Pathway"). Several issues came to light during the first day of testimony, and the FDA was charged with balancing several divergent positions, the most pressing being weighing patient safety and the lowering of costs. At the center of the issue are the standards that the FDA will require for clinical testing of biosimilars. At the hearing, there was a decisive split on how flexible the standards should be. Some testimonials proposed that the only way to be sure that a drug is safe is through extensive clinical trials, while others argued that dangerous and expensive clinical tests are not required because they will be based on drugs that are already proven safe.
Patient safety was the main argument for a strict clinical testing standard. Seth Ginsberg, president of the patient advocacy group Global Healthy Living Foundation, spoke on patient safety at the hearing and was backed by many of the drug companies in attendance. Jim Shehan, a vice president of Novo Nordisk Inc., suggested that both comparative non-clinical and clinical testing of biosimilars is necessary to truly ensure patient safety.
The need for clinical trials was echoed in a press release issued by Amgen, where Senior Vice President of Research and Development Dr. Joe Miletich urged members the FDA to establish approval standards that ensure patient safety and follow a science-based approach. Dr. Miletich emphasized a need for clinical studies with patients, noting that changes in structure, formulation, or impurities can have a significant impact on patients that cannot always be observed with non-clinical analytical studies. Dr. Miletich outlined three key recommendations that the FDA should consider as it moves forward:
1. Use well-designed clinical trials to establish biosimilarity;
2. Ensure the product manufacturer and lot number is known for all administered biologics; and
3. Set scientific and practical criteria for interchangeability.
Critics of a clinical testing standard that may be too extensive pointed to the high costs of repeating unnecessary clinical trials, as well as the ethical questions of repeating potentially dangerous trials in humans. A representative for Senator Bernie Sanders warned that excessive human trials of biosimilar drugs violates the Declaration of Helsinki. In an effort to avoid repeating human trials, Senator Sanders (at right) has offered an amendment to the statute which will require generics makers to pay a fee for access to clinical data. The concern is that a biosimilar applicant will be forced to repeat clinical trails to answer questions of safety and efficacy that have already been answered.
Patent Docs will continue to report on the details of the FDA biosimilar hearings as they become available.
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