FDA answer to low biosimilar uptake? Increased communication

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Korrawin)
(Image: Getty/Korrawin)

Related tags: US FDA, European union

US FDA provides information to patients on biosimilars, emphasizing that the treatments provide the same benefits and are as safe as originator products.

The US’ failure to achieve greater adoption of biosimilars has seen analysts calculate that it could be costing the healthcare system $7.2bn (€6.6bn) each year​.

The outlook in Europe is completely different, as biosimilar producers introduce products onto the market enabling them to state the large savings their products will provide​.

However, the US Food and Drug Administration (FDA) is taking a more active role in trying to encourage the development and approval of biosimilars onto the US market.

In 2018, the agency was able to point towards rising levels of approvals and applications​ as a marker of the development of the sector.

However, a recent study​ in the AMA Journal of Ethics pointed to research that suggested patients have “low levels of awareness of biosimilars as well as concerns about inadequate efficacy and elevated safety risks of biosimilars that are not consistent with reassuring evidence about their clinical usefulness.”

Aiming to rectify this, the FDA has begun communicating directly with patients to ensure that the lack of information available does not deter individuals from being treated with biosimilars.

In its latest release, the agency provides an overview of biosimilars​, including information on benefits and risks, issues of access, and addressed safety and efficacy of the treatments.

Regarding benefits and risks, the information states that biosimilars “provide the same treatment benefits” ​but also “have the same potential side effects”​ as the originator product.

The agency also highlights that its safety process for biosimilars is a four-step process:

  • Approving biosimilars after a careful review of data, studies, and tests
  • Monitoring safety and effectiveness after approval
  • Checking for medication quality during production
  • Reviewing patient safety reports made to FDA

Aside from basic information allaying any fears over lack of equivalency or safety compared with originator product, the release also encouraged patients to talk to their doctor or healthcare provider about whether they will be receiving, or could receive, a biosimilar medicine.

This step could potentially address another barrier to the use of biosimilars, which is healthcare providers’ knowledge of biosimilars​.

Related topics: Markets & Regulations, Biosimilars

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