Business Imperatives

The client needed a regulatory strategy to introduce a novel excipient, in the formulation of a biosimilar monoclonal antibody product, marking its first use in a biological product intended for IV infusion.

Objectives

Supported the client in introducing a novel excipient, into the formulation of a biosimilar monoclonal antibody product by addressing regulatory challenges and ensuring compliance with EMA requirements through the submission of necessary nonclinical and clinical safety data.

Problem Statement

Excessive amounts of the novel excipient impacted the immunogenicity profile of the product, thereby affecting the potency of the drug. The challenge in this project was to convince EMA to approve the use of the novel excipient without requiring additional clinical data to prove the safety of the formulation.

Freyr Solutions and Services

  • Regulatory Strategy: Developed a strategy to conduct additional animal studies on monkeys (repeat dose toxicity studies) to generate toxicokinetic and immunogenicity data demonstrating similarity with the innovator product. 
  • Execution and Submission Support: The data from the animal studies was presented to the regulatory authority to justify the use of the novel excipient in the formulation. The agency accepted the justification, and no further deficiencies were raised by the health authority on this point. 

Successfully supported the client in introducing a novel excipient, into the formulation of a biosimilar monoclonal antibody product. Freyr addressed regulatory challenges and ensured compliance with EMA requirements by facilitating the submission of necessary nonclinical and clinical safety data, leading to the product's approval.