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Biosimilars: Expanding Access to Precision Medicine through Affordable Biologic Therapies

NextEdge Admin

12 Nov 2024

2 min 47 sec

Biosimilars are biologic drugs highly similar to an existing, approved biologic medication, known as the “reference product.” Unlike conventional chemical drugs, which are small molecules made through chemical synthesis, biosimilars are large, complex proteins derived from living cells. Due to their biological origin, biosimilars are unique in structure and behavior, designed to match the reference biologic’s effectiveness, safety, and clinical outcome. Although they are not identical to the reference product, biosimilars undergo stringent regulatory evaluations to confirm that there are no clinically meaningful differences in terms of efficacy, safety, and potency.

Uses of Biosimilars in Medicine

Biosimilars are primarily used in treating chronic and life-threatening diseases, such as cancer, autoimmune disorders, and blood-related conditions. In oncology, biosimilars have proven invaluable, allowing patients greater access to essential therapies at reduced costs. For instance, biosimilars like trastuzumab (e.g., Kanjinti, Ogivri) are used to treat HER2-positive breast and gastric cancers.

Mode of Formation and Role in Precision Medicine

Biosimilars are created using advanced biotechnology. Genetic engineering is used to introduce DNA encoding a specific protein into host cells, such as bacteria, yeast, or mammalian cells, to produce the target protein, which is then harvested and purified. Throughout production, conditions are meticulously controlled to maintain quality, as slight variations in manufacturing can affect the protein’s structure and function.

Biosimilars align with precision medicine by improving accessibility to biologic treatments that target specific biomarkers or disease subtypes. By reducing costs, biosimilars make it easier to deliver biomarker-driven therapies to a broader population, enabling precision medicine’s goal of providing the right treatment to the right patient at the right time. Thus, biosimilars are crucial in making precision therapies more accessible and affordable for diverse patient populations.