Business Imperatives

The client needed a robust regulatory strategy to address the risks associated with developing a biosimilar product using a eukaryotic expression system, while the innovator product was manufactured using a prokaryotic expression system.

Objectives

Supported a pharmaceutical company in mitigating Regulatory risks for a biosimilar developed using a eukaryotic expression system by addressing glycosylated impurities concerns through two strategic approaches to ensure compliance with US FDA requirements.

Problem Statement

The analytical similarities assessment of the biosimilar product revealed the presence of additional glycosylated impurities in the test product, which were absent in the innovator product, posing a significant regulatory hurdle.

Freyr Solutions and Services

Freyr supported this project with multiple regulatory strategies,

  • Strategy 1: Conducted an animal study with a 4X concentration of glycosylated impurities to demonstrate the safety of the biosimilar product.
  • Strategy 2: Included an additional purification step in the manufacturing process to reduce impurity levels to below LOQ thresholds.
  • Both strategies were implemented, and data was presented to the FDA.

Successfully supported a pharmaceutical company in mitigating regulatory risks for a biosimilar developed using a eukaryotic expression system by addressing glycosylated impurities concerns through two strategic approaches, ensuring compliance with US FDA requirements.