Comparative Analytical Evaluation of the Proposed Biosimilar FYB206 and its Reference Medicinal Product Keytruda^®.

ABSTRACT:

Background and objective

Biological medicinal products improve patients' lives, but access is limited, mainly due to high costs. Patents for many existing biological products are expiring, and generic versions, which are referred to as biosimilars, are produced to serve as an alternative to the reference medicinal product (RMP) cutting down the costs and expanding access. The present paper assesses the analytical similarity between Formycon's FYB206 pembrolizumab biosimilar candidate and Keytruda^®, an RMP that is approved to treat various types of cancer, with the intention of determining FYB206's suitability to enter clinical biosimilar trials.

Methods

Monoclonal antibodies (mAbs) are biological medicinal products that are characterized by a high overall heteroge

SUBMITTER: Stuber JC 

PROVIDER: S-EPMC11456019 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature