Biologics & Biosimilars
A biologic drug (biologics) is a product that is produced from living organisms or contain components of living organisms.
Biologic drugs include a wide variety of products derived from human, animal, or microorganisms by using biotechnology.
Types of biologic drugs include vaccines, blood, blood components, cells, allergens, genes, tissues, and recombinant proteins.
A biosimilar product is a biologic product that is approved based on demonstrating that it is highly similar to an FDA - approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
Due to high costs of Biologics, Biosimilars were introduced to provide – more treatment options, increase access & lower costs.
There is no doubt that biologics have transformed the treatment of cancers, autoimmune disorders, and genetic conditions, positively changing many people's futures. Whether treatment is in the form of a biologic or a biosimilar, the FDA's standards for drug approval means that no compromise is made in the product's safety, quality, or efficacy. Regardless of which type of treatment is used, both revolutionary solutions point to exciting future developments in the treatment of cancer and other complex diseases.