AI Article Synopsis
- Biologics are essential medications that help reduce illness and death, but access remains a challenge even in wealthy nations like the USA.
- Misunderstandings about biosimilars, fueled by confusing terminology, hinder patients' access to these important treatments.
- The paper aims to clarify the differences between biologics and the FDA's designation of interchangeability for biosimilars, underscoring the need for more education for both the public and stakeholders involved.
Article Abstract
Biologics are increasingly vital medicines that significantly reduce morbidity as well as mortality, yet access continues to be an issue even in apparently wealthy countries, such as the USA. While patient access is expected to improve with the introduction of biosimilars, misperceptions in a significant part based on terminology continue to make a sustained contribution by biosimilars difficult. Patients are and will continue to suffer needlessly if biosimilars continue to be impugned. Consequently, it is increasingly urgent that semantics are clarified, and in particular, the implication that interchangeable biologics are better biosimilars dismissed. This paper distinguishes between the real differences between biologics that matter clinically to patients and discusses the actual meaning of a US Food and Drug Administration designation of interchangeability for a biosimilar product. This will help highlight where there is need for further Food and Drug Administration education and which stakeholders likely need that education the most.
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9190447 | PMC |
| http://dx.doi.org/10.1007/s40259-022-00538-6 | DOI Listing |
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