Background Current knowledge is limited about which manufacturers are active in the global field of biopharmaceutical product development and how many......
BackgroundBiologics, regardless of whether they are biosimilars or reference products, are inherently variable due to their size, complexity, and the ......
IntroductionRecently, increasing FcRn binding by Fc engineering has become a promising approach for prolonging the half-life of therapeutic monoclonal......
Natural killer T (NKT) cells play a pivotal role as a bridge between the innate and the adaptive immune response and are instrumental in the regulatio......
BackgroundIt is crucial that the safety profiles of biosimilars are similar to those of the original biologics. A better understanding of biosimilars ......
Interleukin (IL)-36 cytokines are members of the IL-1 superfamily of cytokines. IL-36 cytokines are composed of three agonists (IL-36 alpha, IL-36 bet......
BackgroundGB223 is a novel, fully-humanized monoclonal antibody against the receptor activator of nuclear factor-kappa B ligand (RANKL). In this phase......
BackgroundEnzyme replacement therapy (ERT) with alglucosidase alfa is the treatment for patients with Pompe disease, a hereditary metabolic myopathy. ......
The clinical approval of immune checkpoint inhibitors is an important advancement in the field of cancer immunotherapy. However, the percentage of ben......
The last decade has seen significant developments in the field of biologics for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Tr......
Background With the increasing availability biosimilars, the role of pharmacists as drug information specialists has expanded to include promoting bio......
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) in children, causing approximately 3.6 million ......
BackgroundThere is an increasing body of evidence supporting a more flexible approach in clinical data requirements for the approval of more complex b......
A biosimilar product is defined as a biological product that is highly similar to an existing, approved biological product (known as originator or ref......
Background and ObjectiveQX006N is a novel, humanized, IgG4 kappa monoclonal antibody targeting IFNAR1, developed for the treatment of systemic lupus e......
