• SMi Source has 112 microlearning topics and 5 lessons when searching for Biosimilars

  • Lessons

    Click to learn more

    Biotech: Biosimilars

    Biologics

    Diabetes: Insulin Biosimilars

    Diabetes: Type 2

    Biotech: Basics

  • Microlearning Topics

  • Biosimilars

    Examples of Biosimilars

    Biosimilars

    Biosimilars in the Marketplace

    Biosimilars

    Biosimilars Overview

    Biosimilars

    Biosimilars Under Review

    Biosimilarity

    What is Biosimilarity?

    Biosimilars

    Regulatory Milestones and General Requirements for the Production of Biosimilars

    Regulation of Biosimilars

    Summary: Stepwise Approach to Establish Biosimilarity

    Biological Products/Biologics vs. Biosimilars

    Definition of Biosimilarity

    Biosimilar Drug Products

    Biosimilars in the Marketplace

    Biosimilars

    Example of a Biosimilar Not Approved by the EMA

    Biosimilars

    Biosimilar Overview and Definition

    Biosimilarity

    What is Biosimilarity?

    Regulation of Biosimilars

    Evidence Generation: Comparative Data

    Introduction

    Introduction to Biosimilars

    Regulation of Biosimilars

    Manufacturing and Production

    Regulation of Biosimilars

    Reference Product

    Biosimilars

    Benefits, Risks, Marketing, and Claims

    Biosimilars

    Benefits, Risks, and Patent Life

    Regulation of Biosimilars

    Quality and Ingredient Requirements

    Biosimilar Drug Products

    Biosimilars in the Marketplace and Drug Development in the U.S.

    Regulation of Biosimilars

    Allowable Differences Between the Biosimilar and the Reference Biologic

    Biosimilarity

    Demonstrating Biosimilarity

    Biological Products/Biologics vs. Biosimilars

    Demonstrating Biosimilarity

    Biological Products/Biologics vs. Biosimilars

    What Are Biosimilars?

    Biological Products/Biologics vs. Biosimilars

    Regulatory Definitions

    Biosimilars

    Challenges in U.S. Marketplace

    Regulation of Biosimilars

    Approval Process and Regulatory Pathways

    Regulation of Biosimilars

    Hurdles to Approval

    Regulation of Biosimilars

    Evidence Generation: Non-Clinical

    Regulation of Biosimilars

    Substitution and Interchangeability

    Biosimilarity

    What is Biosimilarity?, Demonstrating Biosimilarity

    Regulation of Biosimilars

    Pharmacovigilance and Risk Management

    Regulation of Biosimilars

    Evidence Generation: Clinical

    Regulation of Biosimilars

    Manufacturing Requirements

    Biosimilar Drug Products

    Introduction and Definition: Biosimilars

    Summary: Biosimilars

    Summary: Biologics and Biosimilars

    Biosimilar Insulin Products

    Biosimilar Insulins

    Biosimilar Drug Products

    Demonstrating Biosimilarity: Challenges

    Biosimilarity

    Biosimilarity: Protein Identity and Function

    Biosimilar Drug Products

    Demonstrating Biosimilarity: Comparative Pharmacokinetics

    Biosimilarity

    Demonstrating Biosimilarity: Glucose Clamp Studies

    Biosimilarity

    Comparative Pharmacokinetics

    Biosimilarity

    Demonstrating Biosimilarity: Comparative Pharmacokinetics

    Biological Products/Biologics vs. Biosimilars

    How Similar Is Similar

    Government Regulation and Approval Pathways

    U.S. Food and Drug Administration

    Biosimilar Medical Products

    Patent Cliff and Biologic Medicines in Development

    Government Regulation and Approval Pathways

    European Medicines Agency (EMA)

    Biologic Medical Products

    Overview: Biologic Medical Products

    Biologic Medical Products

    Biologics in the Marketplace

    Government Regulation and Approval Pathways

    Drug Patents and Generics

    Biologic Medical Products

    Overview: Biologics vs. Small Molecule Drugs

    Biologic Medical Products

    Enhancement and Variation

    Biologic Medical Products

    Overview: Regulatory Definitions and Mechanism of Action

    Biosimilarity

    What is Biosimilarity?: Protein

    Biologic Medical Products

    Production of a Recombinant Biologic

    Biologic Medical Products

    Production of Monoclonal Antibodies

    Government Regulation and Approval Pathways

    U.S. Food and Drug Administration: Regulatory Oversight

    Biosimilarity

    Demonstrating Biosimilarity: Pharmacodynamics

    Country-Specific Definitions and Regulatory Guidelines

    Summary of Country-Specific Definitions and Regulatory Guidelines

    Country-Specific Definitions and Regulatory Guidelines

    European Medicines Agency (EMA)

    Country-Specific Definitions and Regulatory Guidelines

    Food and Drug Administration (FDA) Detailed Requirements

    Country-Specific Definitions and Regulatory Guidelines

    European Medicines Agency (EMA) Detailed Requirements

    Introduction

    Country-Specific Definitions and Regulatory Guidelines

    Japanese Ministry of Health, Labour and Welfare (MHLW)

    Country-Specific Definitions and Regulatory Guidelines

    India Ministry of Science and Technology (MST)

    Country-Specific Definitions and Regulatory Guidelines

    South Korea Ministry of Food and Drug Safety (MFDS)

    Biological Products

    Modified Therapeutic Proteins

    Biological Products

    Modified Therapeutic Proteins Improve Function

    Biological Products

    Manufacturing Process

    Biological Products

    Biologics in the Marketplace

    Country-Specific Definitions and Regulatory Guidelines

    World Health Organization (WHO)

    Country-Specific Definitions and Regulatory Guidelines

    Introduction to Country-Specific Definitions and Regulatory Guidelines

    Country-Specific Definitions and Regulatory Guidelines

    Health Canada

    Biological Products

    Biologics and Protein Therapeutics

    Biological Products

    Biologics Overview

    Summary: Biologics

    Summary: Biologics

    Basaglar insulin glargine

    Overview: Basaglar insulin glargine

    Understanding Bioequivalence

    Demonstrating Bioequivalence: Pharmacokinetics

    Basal Insulin: Glargine

    Basal Insulin Analog: Insulin Glargine

    Basaglar Insulin Glargine

    Basaglar Insulin Glargine: Introduction

    Basaglar insulin glargine

    Basaglar insulin glargine

    Basaglar Insulin Glargine

    Summary: Basaglar Insulin Glargine

    Basaglar Insulin Glargine

    Overview: Basaglar Insulin Glargine

    Understanding Bioequivalence

    What is Bioequivalence?

    Basaglar Insulin Glargine

    Summary of Basal Insulin Therapy

    Element-1 Trial

    Element-2 Trial

    Understanding Bioequivalence

    Demonstrating Bioequivalence

    PK/PD of Basaglar

    Use of Basal Insulin

    Basal Insulin Analog

    Biopharmaceuticals

    Patents and Generics

    Biopharmaceuticals

    Biopharmaceuticals
    Patents and Generics
    Biopharmaceuticals: Specificity of Action
    Mak...

    Diabetes Annotations

    Abasaglar insulin glargine

    Biologics: Introduction

    Economic Impact of Biotechnology in the U.S.

    Biologics: Overview

    Biologics: Welcome

    Biologics: Introduction

    Biotechnology

    Biopharmaceuticals/Biologics

    Biologics: Specific Subclass of Drug

    Biopharmaceuticals/Biologics

    Differences Between Biologics and Conventional Drugs (Small Molecules)

    Biopharmaceuticals/Biologics

    Biologics: Categories

    Biopharmaceuticals/Biologics

    Biologics: Approved Biologics

    Biological Products/Vaccines

    Discovery and Development of Biologics

    Biological Products/Vaccines

    Cost of Vaccines

    Biological Products/Allergenics

    Discovery and Development of Biologics

    Biological Products/Blood and Blood Products

    Discovery and Development of Biologics: Blood and Blood Products

    Biological Products/Cell Therapy

    Discovery and Development of Biologics: Cell Therapy

    Biological Products/Gene Therapy

    Discovery and Development of Biologics: Gene Therapy

    Biological Products/Recombinant Proteins

    Discovery and Development of Biologics: Recombinant Biologics

    Biological Products/Recombinant Proteins

    Discovery and Development of Biologics: Mammalian Cell-Based Systems

    Biological Products/Recombinant Proteins

    Enhancement and Variation

    Biological Products/Recombinant Proteins

    Production of a Biologic

    Biological Products/Recombinant Proteins

    Manufacturing-Scale Production

    Biological Products/Regulation

    Regulation of Biologics

    view more