Australia’s TGA Issues Biosimilar Guidance
Australia's Therapeutic Goods Administration (TGA) has issued guidance on the evaluation of biosimilar products, which identifies the data necessary to support applications for the registration of biosimilars and clarifies the scientific and regulatory principles used by the TGA to evaluate applications.
TGA notes that although most biosimilars contain biotechnology-derived proteins as the active substance(s), the guidance also covers biosimilars consisting of vaccines and monoclonal antibodies and polysaccharides, such as low molecular weight heparins. The guidance also underscores that while biosimilars have some conceptual parallels with generic versions of medicines containing chemically-derived small molecules as the active substances, the complexity and microheterogeneity of biotechnology products means that the principles relevant to the evaluation and use of generics cannot be simply extrapolated to biosimilars.
The new guidance also addresses comparability studies for evaluating biosimilars, with sections on physicochemical properties, biological activity, content, purity and impurity profile, glycosylation (if applicable) and immunochemistry (if applicable e.g. monoclonal antibodies); post-registration regulation and pharmacovigilance; biosimilar naming convention; and labeling and product information.