ABSTRACT
Biopharmaceuticals, especially monoclonal antibodies, have emerged as an important treatment option for serious medical conditions such as rheumatoid arthritis, other autoimmune disorders, and cancer. Biosimilar developers may transfer their drug substance and drug product processes to their intended commercial facilities at various points in the development process. Regulators recommend that minimal process changes occur throughout the biosimilar clinical program through to commercial supply. Each process change, scale-up activity, or manufacturing site change during a biosimilar development program requires both a comparability exercise and a similarity exercise. The potential for the biosimilar developer to encounter originator process changes that impact the reference product quality attribute (QA) profile during development of the biosimilar amplifies the difficulty in proposing QA ranges for the biosimilar. Quality target product profile for a biosimilar is achieved through deep understanding of the process and the functional relationship between process parameters used during production and the impact they have on product QAs.
