HYBRID EVENT: You can participate in person at Rome, Italy or Virtually from your home or work.
Miroslav Radenkovic, Speaker at Pharma Conferences
University of Belgrade, Serbia
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. 

Biography:

Miroslav Radenković, MD, MS, PhD, a full-time professor at the Department of Pharmacology, Clinical Pharmacology and Toxicology, graduated from the Faculty of Medicine – University of Belgrade (FMUB) in 1995, and from 1996 he is working at the FMUB. He received an MS from pharmacology, board certified in Clinical Pharmacology, PhD from Medical Sciences, and a sub-specialization degree in Clinical Pharmacology - Pharmacotherapy in 1999, 2000, 2004, and 2016 respectively, from the FMUB, as well as Bioethics MS in 2021 from the Clarkson University, NYC, USA. From 2002 Dr. Radenković officially participated in several scientific projects supported by the Ministry of Science – Serbia; the Austrian Science Fund; COST Action; as well as the NIH Fogarty International Center Project, USA. Dr. Radenković is a member of the Ethics Board of Serbia and a Chair Department.

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