Biosimilars Education for Healthcare Providers

Biosimilars offer prescribers and patients valuable additional options when it comes to treatments. To help, we've put together some resources and information for prescribers to better understand the safety, efficacy, and quality of biosimilars.

Safety and Efficacy

All biosimilars undergo strict comparative analytical, nonclinical, and clinical evaluations prior to market approval — to verify that there is no unanticipated variation in potency, quality, efficacy or safety – and ensuring healthcare professionals and their patients can trust the safety and effectiveness of the biosimilar, just as they would for the reference product.¹

When discussing biosimilars there are four key points your patients should know:

Carefully Evaluated

Regulatory bodies, like the U.S. FDA, require that the manufacturer demonstrate similarity of the biosimilar with the reference product.² This includes:

• Data, studies, and tests
• Ongoing safety monitoring
• Regular quality checks when a biosimilar is made

Proven Similarity

Regulatory bodies like the U.S. FDA require that all biosimilars undergo rigorous regulatory review to ensure the biosimilar is highly similar to, with no clinically meaningful difference from, the reference biologic.² This includes:

• Same benefits
• Same strength and dosing
• Same route of administration
• No meaningful differences in effectiveness or possible side effects

Benefits

Biosimilars provide the following benefits:

• More treatment options³
• Potentially lower costs⁴
• Increased competition among medicines⁴

Backed By Experience

Biosimilars are required by stringent regulatory bodies, such as the U.S. FDA, to be:

• Developed with scientific expertise
• Supplied by manufacturers with adequate manufacturing capabilities

Biosimilar Product Interchangeability

Biosimilar Interchangeability in the U.S. and E.U. refer to different things.

In the U.S., it is an optional designation relevant to pharmacy substitution, whereas in the E.U., interchangeability refers to a prescriber switching a patient from one product to another. The EMA has not taken a position on pharmacy substitution of biosimilars, as this is regulated at the E.U. member state level.⁵

U.S. interchangeability is established on a case-by-case basis. The decision to pursue interchangeability is at the discretion of the biosimilar manufacturer. An interchangeable biosimilar may be substituted at the pharmacy without the intervention of the prescriber, much like how generic drugs are routinely substituted for brand-name drugs, subject to state or national pharmacy laws.

The criteria used by FDA to evaluate interchangeability is as follows:⁶

• Meets requirements as a biosimilar:
• Product is highly similar to reference biologic notwithstanding minor differences in clinically inactive components, and
• Product has no clinically meaningful differences in efficacy and safety.
• An expectation of producing the same clinical results as the reference biologic in any given patient; and
• The risk in terms of safety or efficacy of switching or alternating between biological products is no higher than using the originator product alone.

Extrapolation

Extrapolation of data is used to support the approval of a proposed biosimilar product in one or more additional indications for which the reference product is licensed, but for which the biosimilar has not been studied in clinical trials.⁷

Extrapolation has the potential to reduce or eliminate the need to study a proposed biosimilar with clinical trials in every indication of the reference product. But it is not an automatic process. It is based on all available data in the biosimilar application and appropriate scientific justification.⁷