BIOSIMILAR - Cellular Molecular pharmacology

biosimilar as drugs candidates

1. Chhatrapati S hahu J i M aharaj 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 ?

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 Chemical & therapeuti equivalents of chemical drugs. Structure : smaller ,less complex, 1D Molecular weight: low Biosimilar Copies of existing biological medicinal products or protein drugs. large & complicated (100-1000x) ,3D High

10. Generic drugs More stable Route: oral Manufacturing procedure : less complex Registration procedure: simple (ANDA) Biosimilars Sensitive to change in physical conditions. Injected / Inhaled Complex , lengthy &expensive (require different cell lines) 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. 4 Major concerns : Safety Substitution Naming Labelling POTENTIAL CONCERNS

13. MANUFACTURING PROCESS OF BIOSIMILARS

14. THANK YOU…