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