Determination of functional similarity of biosimilar H9P2S from an investigational CHO clone with Adalimumab

Biosimilars, which are replicas of innovator pharmaceuticals, constitute the most significant share of biopharmaceutical products. These products are associated with structural and manufacturing complexities and are hence considered as similar to innovator drugs. Adalimumab is a monoclonal antibody that has been approved by the US FDA for blocking TNF-α. Adalimumab, also known as Humira, is preferred over other anti-TNF-α mAbs because of its lower immunogenicity and enhanced clinical efficacy. As cost-effective mAb development is still a challenging area, we developed an in-house stable CHO-K1 cell line for the production of recombinant monoclonal mAb against TNF-α. This clone yielded H9P2S, as a biosimilar against TNF-α, for which several functional assays were conducted to prove its biosimilarity to Adalimumab. Two batches of H9P2S and their subsequent dilutions were compared with Adalimumab. H9P2S and Adalimumab showed highly similar TNF-α binding and neutralizing activities, confirming the suitability of our clone for yielding biosimilar drugs.