The Biosimilar Pathway
Biosimilars are biologic medications that are developed to be highly similar to an already licensed biologic product, known as the reference product. The regulatory pathway for biosimilar approval was established in the United States in 2010 through the Biologics Price Competition and Innovation Act (BPCIA). This law created an abbreviated approval pathway through the Food and Drug Administration (FDA) for biosimilars to demonstrate they are highly similar to an already approved reference product in terms of safety, purity and potency.
Through analytical studies, nonclinical studies, and clinical pharmacokinetic and pharmacodynamics studies, Oncology Biosimilars must show there are no clinically meaningful differences between the biosimilar and reference product. Full clinical efficacy and safety trials are not required for biosimilar approval, unlike for novel biologic products. This abbreviated pathway was established to help increase patient access to biologics that are clinically equivalent but potentially lower in cost compared to the reference product, due to greater market competition once biosimilars are approved and available.
Importance of Interchangeability
An important regulatory concept for biosimilars is interchangeability. For a biosimilar to be designated interchangeable by the FDA, it must not only be biosimilar but also expected to produce the same clinical result as the reference product in any given patient. This allows a pharmacist to substitute an interchangeable biosimilar for the reference product without additional consent from the prescribing physician.
The development pathway to demonstrate interchangeability involves additional switching studies that are not needed for biosimilar approval alone. To date, the FDA has approved one oncology biosimilar as interchangeable. Greater regulatory clarity and additional interchangeable biosimilar approvals are still needed to optimize patient access and choice through appropriate substitution in clinical practice.
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