How are Biosimilars Developed and Made?
The Goal: “No clinically meaningful differences”
Because biosimilars are produced from living organisms, biological products generally have more variability than traditional chemical drugs. In fact, biologic medicines of all kinds have some variability between lots, even when manufactured by a single company.
Therefore, the goal in creating a biosimilar is to make a safe and effective therapy that treats a disease the same way as the original biologic medicine, while also falling within the same variability limits as batches of the originator biologic medicine. To achieve this, the FDA requires biosimilars to meet a rigorous scientific standard of similarity and be deemed “highly similar” before they are made available to patients.
Biosimilar manufacturers use a reverse engineering process to produce a biosimilar; in that, they do not always have access to the original cell line used to produce the originator biologic medicine, but must fall within the originator’s batch variability limits for regulatory approval.
Biosimilar manufacturers conduct batch analyses of multiple batches of the originator biologic medicine, perform analytical and functional characterizations, and upstream and downstream manufacturing processes developed based on previously defined quality attributes. Similarity is achieved and verified through a scientific process that confirms there is no clinically meaningful difference between the biosimilar and the original product, even if there are slight differences in clinically inactive components. The same approach is used when manufacturing process changes are instituted by the originator biologic company.