Published Paper Details:

Biologics and biosimilars have emerged as pivotal components of modern healthcare, offering innovative solutions to a wide range of diseases. This poster delves into the intricacies of these biological products, their development, regulatory frameworks, and their impact on the global healthcare. Biologics are a category of medications derived from living organisms, such as cells, tissues, or proteins, and are used to treat a wide range of diseases, especially those that cannot be addressed effectively by traditional small-molecule drugs. Unlike chemically synthesized drugs, biologics are made from complex biological sources like human or animal cells, bacteria, or yeast and Biosimilars are highly similar, but not identical, versions of biologics that have lost patent protection. Like generic versions of small-molecule drugs, biosimilars offer more affordable alternatives to biologics. Biological medicines (biologics) are produced in living cells and purified in complex, multi-step processes. Compared with chemically synthesized small-molecule drugs, biologics are more sensitive to changes in manufacturing conditions. Process and product consistency should be founded on rigorous design and control of manufacturing processes, but consistency is ultimately ensured through robust quality systems. Even a minor change in any component of a quality system could lead to product drift, evolution, and divergence, which may impact the quality, safety, efficacy, and/or interchangeability of biologics. The therapeutic success of biotechnological drugs, commonly designated as biologics, such as monoclonal antibodies (mAbs) and recombinant versions of endogenous proteins, is increasingly transforming the pharmaceutical market. Patent expiry of biologics (ie, originators) has also opened the field to the so-called biosimilars, medicines that are intended to be similar, although not identical, to the originator biologics in terms of quality, efficacy, and tolerability. It is undeniable that there are highly debated issues regarding biosimilars in immune-mediated inflammatory diseases: increasing demand for biologics given their clinical success, the nearing of patent expiry for the 4 top-selling biologic brands, and the search for reducing the economic burden of drugs.