Testing the Quality, Safety, and Efficacy of Insulin Biosimilars

The investment will be done over five years and will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple US states.

Celltrion’s adalimumab-aaty is designated interchangeable as a high-concentration (100mg/mL) and citrate-free formulation of adalimumab.

Eculizumab-aagh (EPYSQLI) is now available in the US to treat patients living with difficult-to-treat rare diseases such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and generalized myasthenia gravis.

The EMA has issued a new proposal that aims to encourage biosimilar development and improve patient access to biosimilar therapies.

This paper outlines a systematic approach to detecting contamination through process deviations, including changes in % dissolved oxygen, pH, and metabolic patterns.

Process consistency and robustness, analytical excellence, and regulatory compliance are essential in the scale-up of biosimilars.