Consistency of Product Quality for SB5, an Adalimumab Biosimilar

BackgroundBiologics, regardless of whether they are biosimilars or reference products, are inherently variable due to their size, complexity, and the manufacturing process involved to produce them. Since a drift or evolution of quality attributes of a biologic may impact its clinical safety or efficacy, it is critical for the manufacturer to carefully control the manufacturing process and monitor the quality attributes of a biologic.ObjectiveThe aim of this study was to demonstrate that the quality profile of the SB5 drug product has been consistent over its production history from 2013 to 2022. SB5 is a biosimilar referencing adalimumab (Humira, trademark of AbbVie Biotechnology Ltd) and SB5 has been approved by 14 regulatory authorities including the European Commission in August 2017 (brand name Imraldi (TM)) and the US Food and Drug Administration in July 2019 (brand name Hadlima (TM)).MethodsA total of 93 SB5 drug product batches manufactured between 2013 and 2022 were analyzed for a series of release parameters to evaluate the consistency in their critical quality attributes including purity, charge variants, and functional activities (TNF-alpha binding activity and TNF-alpha neutralizing potency).ResultsThe purity, charge variants, and functional activities of all batches were consistent over time and within the stringent acceptance criteria defined by regulatory agencies to ensure the safety and efficacy of SB5.ConclusionThe data presented in this study provide evidence that the quality of SB5 has remained consistent and tightly controlled even through process changes such as manufacturing site transfers and change in formulation.