In addition to generics, innovator medicines may also require demonstration of bioequivalence between early and late-stage clinical trial formulations, between formulations used in clinical trials and the product to be marketed, and changes in excipients following approval of the innovator. In addition to demonstration of bioequivalence by generics, biosimilars approval also requires demonstration of bioequivalence with a reference biological product. Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from approved reference products. Unlike generics, biosimilar approval requires more extensive preclinical and clinical studies as biologics are large, complex molecules. Clinical studies to assess similarity between the pharmacokinetic and pharmacodynamic profiles between the biosimilar and reference product is necessary for approval.
In bioequivalence studies, the plasma concentration-time curve is used to assess the rate and extent of absorption and pharmacokinetic parameters such as area under the curve (AUC), maximum plasma concentration (Cmax), and time to maximum plasma concentration (tmax) and prespecified acceptance limits are used to assess bioequivalence. Additional ways to establish bioequivalence include in vitro tests predictive of human in vivo bioavailability (in vitro-in vivo correlation IVIVC), pharmacodynamic (PD), clinical endpoint, and in vitro studies.
With increasing competition between pharmaceutical companies to launch their generics in the market, it is important to have experts to guide you through your bioequivalence studies to enable timely launch of your generic product. Our team at ProRelix research can help with clinical studies to demonstrate bioequivalence for both small molecules and biologics. We are well-versed with bioequivalence studies for solid oral dosage forms, parenteral formulations, topical products, inhalation products, and rectal and vaginal systems.
