Abstract
Biosimilar medicines are highly similar to FDA approved reference biologics. The sponsor’s intended use claim plays an important role in the use of biosimilar medicines in specialty therapy categories such as immunology, endocrinology, oncology. The new biosimilar products approved by the FDA, play a pivotal role in the clinical treatments of patients suffering from life-threatening diseases such as cardiac myopathies, carcinoma, sarcoma, lymphoma. The US biosimilar approval process requires a thorough characterization of the new biosimilars with a clinically meaningful outcome. Sponsors of new biosimilars follow the appropriate ICH guidelines in regard to clinical PK/PD, safety and efficacy studies. The FDA guidances for extrapolation and interchangeability state that data derived from clinical studies should be adequate to demonstrate purity, potency, safety and the intended clinical use of the new biosimilar in comparison to previously approved licensed biologics. This article emphasizes the FDA’s quality system approach to the design of studies for clinical applications for designated specialty therapy categories.
Highlights
Biosimilars are medicines that are highly similar to their approved reference biologics as they claim to have no clinical differences in purity, potency, and safety
Biosimilars have recently emerged as a new class of biologic drug that has the potential to have access to many critical medicines through the reduction of costs
There is a need to ensure that new biosimilars are as safe and effective as their innovative counterparts
Summary
Biosimilars are medicines that are highly similar to their approved reference biologics as they claim to have no clinical differences in purity, potency, and safety. The new discoveries of innovative biosimilar products continue to challenge the clinical treatments for patients suffering from chronic diseases (i.e., carcinoma, sarcoma, lymphoma, etc.). These new innovative treatments have placed an immense economic burden on emerging market developments and healthcare systems delivery. Review Article sponsors of premarket applications must present analytical and biological characterization to demonstrate that a proposed biosimilar is highly similar to a licensed reference product. The premarket application protocol requires a sponsor to describe the biosimilar product’s PK/PD clinical data comparing its safety, efficacy, and immunogenicity to that of the reference product. A brief description is presented on risk-benefit analysis that guides the clinical use of the new biosimilar drug product by providing patients’ organized data and appropriate labeling information in conformance with the new biosimilar drug’s intended clinical use [1,2]
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