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The US Congress passed the Biologics Price Competition and Innovation (BPCI) Act in 2009, authorizing the FDA to oversee an “abbreviated pathway” for approval of biologics that are “biosimilar” to already approved biologic products.⁶⁴ The BPCI Act (also known as the Affordable Care Act) aligns with the FDA's longstanding policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary testing.

Under the BPCI Act, a sponsor may seek approval of a “biosimilar” product. A biological product may be demonstrated to be “biosimilar” if data show that the product is “highly similar” to the reference product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency.

In order to meet the higher standard of interchangeability, a sponsor must demonstrate that the biosimilar product can be expected to produce the same clinical result as the reference product in any given patient and, for a biological product that is administered more than once, that the risk of alternating or switching between use of the biosimilar product and the reference product is not greater than the risk of maintaining the patient on the reference product. Interchangeable products may be substituted for the reference product by a pharmacist without the intervention of the prescribing health‐care provider.

The BPCI Act intended to facilitate timely approval of and access to biosimilars to US citizens. Recent evidence appears to suggest that this goal has not been achieved and other essential steps are required.^2,65