Dr. Lyman on the Process for Approving Biosimilars

Gary H. Lyman, MD, MPH
Published: Friday, Mar 22, 2019



Gary H. Lyman, MD, MPH, medical oncologist, Fred Hutchinson Cancer Research Center, discusses the differences in approving a biosimilar and the original biologic product in an interview during the 2019 NCCN Annual Conference. Biosimilars are approved by the FDA based on different mechanisms than the original products were approved, some as long as 20 years ago.

Original biologics had to provide both preclinical data and several randomized, controlled trials demonstrating safety and efficacy for approval from the FDA. However, this process is extremely costly, Lyman explains. To facilitate the development of biosimilars, the FDA created a more expedited process for the approval of biosimilars a few years ago, in which emphasis is put on the molecular characteristics, structure, and the product’s biologic behavior in the patient. This should demonstrate that the biosimilar is highly similar to the original product without the additional cost of large, randomized, phase III trials.

By reducing cost for clinical trials, the cost reduction should be able to pass on to lower pricing of these products in the marketplace. Lyman says the idea is that if the preclinical work shows that a biosimilar is essentially the same molecule with the same mechanism of action and doesn’t have any safety concerns, it should function the same as the original product.

<<< 2019 NCCN Annual Meeting


Gary H. Lyman, MD, MPH, medical oncologist, Fred Hutchinson Cancer Research Center, discusses the differences in approving a biosimilar and the original biologic product in an interview during the 2019 NCCN Annual Conference. Biosimilars are approved by the FDA based on different mechanisms than the original products were approved, some as long as 20 years ago.

Original biologics had to provide both preclinical data and several randomized, controlled trials demonstrating safety and efficacy for approval from the FDA. However, this process is extremely costly, Lyman explains. To facilitate the development of biosimilars, the FDA created a more expedited process for the approval of biosimilars a few years ago, in which emphasis is put on the molecular characteristics, structure, and the product’s biologic behavior in the patient. This should demonstrate that the biosimilar is highly similar to the original product without the additional cost of large, randomized, phase III trials.

By reducing cost for clinical trials, the cost reduction should be able to pass on to lower pricing of these products in the marketplace. Lyman says the idea is that if the preclinical work shows that a biosimilar is essentially the same molecule with the same mechanism of action and doesn’t have any safety concerns, it should function the same as the original product.

<<< 2019 NCCN Annual Meeting



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