Title : Biosimilars - The current progress
Abstract:
Biosimilars are biologic medicinal products highly similar to previously approved reference biopharmaceuticals. They are developed to have no clinically significant differences in safety, purity, and potency. In other words, a company developing a biosimilar will need to prove that its product is highly similar to the characteristics of the reference product in terms of purity, chemical identity, and bioactivity. The manufacturer must also demonstrate that its product has no clinically important divergences to the reference product in terms of safety, purity, and potency (safety and effectiveness) which is determined though human pharmacokinetic and pharmacodynamic studies, and supplementary clinical studies if needed. Biosimilars have become more common in the treatment of pathological conditions like cancer, autoimmune diseases (e.g., rheumatoid arthritis, Crohn's disease), and chronic kidney disease (for anemia management). A number of biosimilars are now being approved for multiple indications (e.g., oncology, autoimmune diseases), making them more flexible treatment alternatives and allowing for broader market dissemination. Biosimilar products can only be dispensed in place of another biological product if the health care provider specifically prescribes the biosimilar product by name. These drugs have the potential to reduce drug costs, thus offering lower-cost treatment options for patients. Taking into account previous facts, the main objectives of this presentation will be to review novel biosimilars, as well as to clarify their main the pharmacological properties, including pharmacodynamics, pharmacokinetics, indications and contraindications for use, adverse drug reactions, as well as the most important drug interactions. This will provide a better understanding of this specific group of drugs, consequently helping clinicians in their adequate prescribing and suitable clinical use.
