Relevance of Adalimumab Product Attributes to Patient Experience in the Biosimilar Era: A Narrative Review

AbstractAdalimumab (ADL, Humira®, reference product), an anti-TNF- α biologic, has transformed the treatment of chronic, immune-mediated inflammatory diseases. However, the high cost of ADL therapy has driven the development of more affordable ADL biosimilars, agents with no clinically meaningful differences from the reference product. This review summarizes the p roduct attributes of reference ADL and the nine ADL biosimilars approved and available in the USA in relation to patient experience of injection-site pain (ISP). Product formulation, delivery volume and device features (e.g., type and needle gauge size) influence patient experience of ISP with poten tial clinical consequences. Citrate-free formulations generally cause less ISP; injection volumes of >  1.5 ml may be associated with increased ISP. Reference ADL and all ADL biosimilars offer a citrate-free formulation, and reference ADL and four ADL biosimilars offer a high-concentration solution that allows a smaller injection volume. All available ADL products are injected subcutaneously using either a pre-filled pen (PFP) or pre-filled syringe (PFS). Patients prefer the PFP, but the PFS permits better control over the speed and duration of injection. Smaller (29-gauge) needle outer diameter is associated with less ISP; reference ADL and seven ADL biosimilars offer a device with a 29-gau ge needle. In the USA, an approved biosimilar can be designated “interchangeable,” allowing pharmacy-level substituti...
Source: Advances in Therapy - Category: Drugs & Pharmacology Source Type: research