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What is a biosimilar?

Biosimilars are treatments that mimic the active ingredients of biologics, a class of drugs that include gene therapies, stem-cell therapies, monoclonal antibodies, and insulin. As the patents of these drugs expire, biosimilars can step into the field by mimicking a reference biologic.

Biosimilars are not exact replicas of biologics, as biologics are highly complex molecules that are grown instead of synthesized, providing them with micro-variability. This variability makes it so that biosimilars cannot be exact copies.

Along these same lines, generic drugs and biosimilars are not the same, as generic versions use an identical active ingredient. In contrast, biosimilars have active ingredients with the same mechanism of action and expected benefits and risks, even if they are not identical.

Still, like other drugs, biosimilars must follow standards set by the U.S. Food and Drug Administration (FDA), such as being similar to the reference biologic in both its structure and function.

How do biosimilars improve healthcare?

Biologics are expensive for biopharma companies to develop and often have high price tags, which can make them challenging for patients to acquire despite the benefits they can offer.

Biosimilars offer a lower-priced solution since much of the upfront development phase has already been completed. By reducing the costs of drugs, biosimilars make it possible for more patients to access these medicines while also offering savings to the healthcare system.