After any product has been approved by the regulatory authorities, it is quite common for further changes to be made in the manufacturing process, such as7:
- Upscaling the process
- Yield improvement
- New purification methods
- Change of cell line
- Change of manufacturing site
As these changes are introduced during the life-cycle of the product, the quality, safety and efficacy of the product post-change must be proven to be comparable to that of the product pre-change. As a general scientific principle, comparability does not necessarily require the products pre and post-change to be identical, instead, comparability within certain parameters needs to be verified5.
This same general scientific principle of comparability is used in the development and assessment of biosimilars, which must have comparable quality, efficacy, and safety to the reference biologic medicine8,9.