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Exploring Biosimilars in Cellular Molecular Pharmacology at Chhatrapati Shahu Ji Maharaj University

Biosimilars, highly similar to FDA-approved biological products, have a complex history and distinct differences from generics. They are crucial in modern pharmacotherapy, with uses in various medical conditions. However, concerns around safety, substitution, naming, and labeling persist. Understanding the manufacturing process is key, as it involves intricate steps due to biosimilars being biological products. With the potential to capture a significant share of the pharmaceutical market, biosimilars play a vital role in healthcare.

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Exploring Biosimilars in Cellular Molecular Pharmacology at Chhatrapati Shahu Ji Maharaj University

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  1. Chhatrapati Shahu Ji Maharaj University BIOSIMILARS {CELLULAR MOLECULAR PHARMACOLOGY}

  2. CONTENT  INTRODUCTION  DEFINATION  BIOSIMILAR HISTORY  DIFFERENCE B/W BIOSIMILARS & GENERICS  USES OF BIOSIMILARS  POTENTIAL CONCERNS  MANUFACTURING PROCESS

  3. INTRODUCTION  BIOLOGICAL DRUGS – essential part of modern pharmacotherapy  FIRST DEVELOPMENT IN 1980s –  Recombinant technology Complex proteins (eg. Monoclonal Abs)  (DNA manipulation in bacteria, yeast or mammalian cells)

  4.  Other eg. – cytokines, hormones, interleukins, human insulins, clotting factors, enzymes, vaccines, cell & tissue based therapies .  Up to 50% share in global pharmaceutical market in the next few years .

  5. WHAT ARE BIOSIMILARS ? A BIOLOGICAL MEDICAL PRODUCT WHICH IS ALMOST AN IDENTICAL COPY OF AN ORIGINAL PRODUCT THAT IS MANUFACTURED BY A DIFFERENT COMPANY . A biological product highly similar to an FDA – approved biological product and has no clinically meaningful difference in safety and effectiveness .

  6.  The Synonyms… Follow – on Biologics (FoBs) Follow – on protein Follow – on biologic similar biomedicines subsequent entry biologicals SBMP (similar biological medicinal product)  BIOSIMILARS ARE NOT (BIO)GENERICS.

  7. Biosimilars includes :  Blood and plasma products  Non recombinant product  Recombinant products  Monoclonal antibodies  Vaccines

  8. Biosimilar history :  In late 1960s , the FDA developed the abbreviated new drug application for approval of generic drug.  The first ever “similar biologic “ product manufactured by INDIA was a Hep-B vaccine named BIOVAC B in 2000.  The first biosimilar approved by EMEA was OMNITROPE which is a biosimilar Recombinant Human Growth Hormone In year 2006.  US-FDA manufactured first follow up biologics Zarixo( Filgastrim) in 2015.

  9. Why biosimilars are not generic drugs? Generic drugs Biosimilar Chemical & therapeuti equivalents of chemical drugs. Copies of existing biological medicinal products or protein drugs.  Structure : smaller ,less complex, 1D large & complicated (100-1000x) ,3D  Molecular weight: low High

  10. Generic drugs Biosimilars  Sensitive to change in physical conditions.  More stable  Route: oral  Injected / Inhaled  Manufacturing procedure : less complex  Complex , lengthy &expensive (require different cell lines)  Registration procedure: simple (ANDA)  Complicated (EMEA/ FDA)

  11. USES OF BIOSIMILARS  Blood conditions: leuko/ neutro / pancytopenias  Cancers: Colon & Breast Ca or NHL  Immune system disorders : Rheumatoid arthritis, Psoriasis & Crohn’s disease  Neurological disorders: Multiple Sclerosis

  12. POTENTIAL CONCERNS 4 Major concerns : Safety Substitution Naming Labelling

  13. MANUFACTURING PROCESS OF BIOSIMILARS

  14. THANK YOU…

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