Biosimilars and Follow-on Biologics
A biosimilar (or follow-on biologic) is a biological product that is highly similar to an already approved biological product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved biological product in terms of the safety, purity, and potency.
There are many factors that are crucial to the successful development and commercialization of biosimilars and biobetters (i.e., biosimiliars that are improved versions of the original product). Some of the more critical factors are:
To be successful, developers of biosimilars must be able to demonstrate to regulatory authorities a high degree of structural and functional similarity between their product and the approved original product. Proof of similarity often requires the employment of analytical technologies such as the surface plasmon resonance (SPR) technology used in Biacore systems.
Biosimilar developers must convince authorities that the biosimilar manufacturing process is well understood, controlled, and robust. Process understanding starts in the development lab, and can be simplified with process development tools like prefilled 96-well PreDictor plates for high throughput studies and ÄKTA avant for easy and robust purification. Process robustness can be achieved through the use of documented and scalable BioProcess chromatography media (resins), columns, and systems.
A challenge for the biosimilar developer is to manufacture a product at a lower cost than the originator. Single-use technologies, such as GE Healthcare Life Sciences ReadyToProcess and Xcellerex systems, cover both upstream and downstream bioprocessing and offer low cost of acquisition, while providing a flexible alternative to traditional stainless steel production plants. Additionally, modern chromatography media like MabSelect and Capto media can significantly reduce the costs for downstream purification as well as increase productivity.