Developing Biosimilars: Challenges And Solutions

Biosimilars are biological medicines that are extremely similar to already approved biopharmaceutical drugs (originator or reference medicinal product (RMP)). It is important that there are no clinically meaningful differences between the biosimilar and its RMP in terms of the safety, purity, and potency of the product but minor differences in clinically inactive components are allowed.

Approval of biosimilars consist of comprehensive comparability studies including the assessment of critical quality attributes (CQAs) of the reference medicinal

products that affect identity, purity, biological activity, and stability of the biosimilar drug. Biosimilarity needs to be demonstrated throughout the entire process including cell line development and QC of the manufacturing process.

For biophysical characterization using both in vitro and cell-based assays, scientists often need multiple and orthogonal technologies. These instruments often require expensive reagents, large high quantities of samples and experimental conditions optimization. Simplified analytical workflows are therefore needed.