BO4003 Biogenerics and Biopharmaceuticals Syllabus:

BO4003 Biogenerics and Biopharmaceuticals Syllabus – Anna University PG Syllabus Regulation 2021

COURSE OBJECTIVES:

The course aims to,
 Introduce the students about biogenerics and biosimilars and their characterization using analytical methods.
 Correlate the conceptual learning of biopharmaceuticals with their therapeutic equivalence using case studies.

UNIT I BIOGENERICS INTRODUCTION

Definition: Generics and its advantages; Biogenerics and Biosimilars; why biosimilars are not (bio) generics; The advent of Biosimilars; The role of patents in the drug industry; Protein-based biopharmaceuticals; Manufacturing processes; Global market; International Non-proprietary Names (INN) nomenclature system biosimilars regulation (EU position, US pathways, Government initiatives)

UNIT II BIOSIMILARS AND ITS SCENARIO

Approved follow-on proteins/Biosimilars; Characteristics of high selling peptides and proteins,; Products with expired patents; Challenging originator’s patents; Target products for FOB (follow-on biologics) /Biosimilars development peptides; Recombinant Non Glycosylated proteins; Recombinant glycosylated proteins; Industries dealing with biogenerics and its market value; World scenario; Indian scenario.

UNIT III CHARACTERIZATION OF BIOSIMILARS

Approaches to the characterization of biosimilars; Problems in characterizing biologics (Types of biologic, Peptides, Non-glycosylated proteins, Glycosylated proteins, Monoclonal antibodies); Equivalence issues; Post-translational modifications; Effect of microheterogeneity; Pharmacokinetics; Pharmacodynamics; and Clinical efficacy; Analytical Methods for the characterization of biosimilars (Chromatography, Protein sequencing, Mass Spectrometry, UV absorption, Circular dichroism, X-ray techniques, Nuclear magnetic resonance, Electrophoresis, Western blotting, Bioassays, ELISA, Immunoprecipitation and other procedures)

UNIT IV IMMUNOGENICITY OF BIOPHARMACEUTICALS

Immunogenicity of biopharmaceuticals: Immunogenicity; Factors contributing to immunogenicity, (product-related factors and host-related factors), consequence of immunogenicity to biopharmaceuticals; Measurement of immunogenicity.

UNIT V CASE STUDIES

Case studies: Erythropoietin, Insulin, Somatotropin, Interleukin-2, Interferon Granulocy temacrophage-CSF, DNase, Factor VIIa, Factor IX, Factor VIII, Activated protein C, Tissue plasminogen activator, Monoclonal antibodies etc., Immunogenicity of biopharmaceuticals: Immunogenicity; Factors contributing.

TOTAL : 45 PERIODS

COURSE OUTCOMES:

At the end of the course the student will be able to
CO1. Acquire knowledge about biogenerics, biosimilars, their nomenclature and regulations.
CO2. Update the patent and market scenario of follow-on proteins.
CO3. learn about the characterization of biosimilars.
CO4. Attain the knowledge of immunogenicity of biopharmaceuticals
CO5. Have exposure on case studies dealing with immunogenicity of biopharmaceuticals
CO6. Apply the knowledge of biopharmaceuticals regulations, characterization and it Immunogenicity properties

REFERENCES:

1. Niazi, Sarfaraz K. “Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues”. CRC Press, 2006.
2. Ho, Reedney J. Y., MiloGibaldi. “Biotechnology & Biopharmaceuticals Transforming Proteins and Genes into Drugs”, 2nd edition, 2013