Drugs based on proteins, or biopharmaceuticals are useful for the treatment of a wide range of illnesses and form one of the fastest-growing areas in medical research. As these products are used in vivo to treat disease, they are subject to extremely high regulatory burdens and must be able to demonstrate that they are effective but also safe.
The stability and aggregate level that these biologics contain is of primary concern as they influence the efficacy and immunogenicity of the final product. Detailed information on these parameters needs to be provided to help scientists drive development in the direction that produces a high quality and reliable product. Importantly it is also essential information for regulators to qualify and allow the release of the product.
Changes in FDA regulations allowed the development of biosimilars which have the same function as the innovator but are significantly cheaper. Biosimilars have shortened licensing pathways when compared to innovator materials if they can be shown to be biologically similar to already licensed products. For a product to be considered as biosimilar it must undergo detailed analytical studies demonstrating that it is highly similar to the innovator and include information to show that it is expected to produce the same clinical response as the innovator in any given patient.
A successful biosimilar program has comparative analytical data as its foundation. As part of the analytical study, the FDA requires the use of state-of-the-art technology to compare higher-order structures, including aggregation, of the biosimilars with the innovator in addition to any formulation effects on purity, stability, product and process-related impurities.
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