Approved Products

Please click the links below to download the PDF versions of the following documents:

Prescribing Information
Medication Guide
Patient Instructions for Use

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Next: Our Pipeline

Amgen & Biosimilars

Amgenʼs Biologics Story

Expanding our global patient reach.

Mission & Values

The values of Amgen are grounded in our mission to serve patients.

Our Commitment to Biosimilars

Learning from the past, developing for the future.

Manufacturing Excellence

Every patient, every time.

Careers

Focus your career on a promising future.

Contact Us

The Basics

The Power of Biologics

Revolutionizing treatments for patients with serious illnesses.

What Are Biosimilars?

Unique therapeutic options for patients.

Biosimilars vs Generics

Important distinctions between biosimilars and generics.

How Biosimilars Are Approved

In highly regulated markets, biosimilars will be approved based on robust data packages that demonstrate similar patient efficacy, safety, and immunogenicity profiles as reference products.1

Naming and Prescribing

Distinct nonproprietary names and transparent labeling are fundamental for appropriate use and prescribing.1

The Use of Biosimilars

Distinct therapeutic options.

The Science

Biosimilar Development

Biosimilar development is a highly skilled, multistep process and requires extensive understanding of the reference product.1

Critical Quality Attributes

Matching biological function and critical quality is the art of biosimilar development.1

Clone Identification

Creating and selecting a promising clone from thousands of cells requires thorough understanding of the reference product and deep scientific capabilities.1

State of the Art Analytics

Highly sensitive methods are essential to analytical understanding—the cornerstone of demonstrating biosimilarity.

Clinical Trial Design

Robustly designed clinical trials are important for regulatory approval, to inform treatment decisions, and to help instill confidence.1

Totality of Evidence

Robust analytical, non-clinical, and clinical data will be reviewed to understand the level of similarity of a proposed biosimilar.1

Manufacturing

How a Biologic Is Made

Manufacturing biologics is a complex process.1

Quality Processes for Medicines

Investing in high-quality manufacturing.

Reliability of Supply for Patients

Committed to ensuring a reliable, consistent supply of medicines to patients.

Comparability vs Biosimilarity

Manufacturer process changes ≠ biosimilar development.1

Take the Tour

Step inside Amgen’s manufacturing process to learn more about our innovative biologics and biosimilars.

Our Products

Approved Products

Our Pipeline

Clinical Trials

Media

Media Releases

Selected press releases, quarterly earnings press releases, and Amgen-issued statements related to biosimilars.

Resources

Amgen Biosimilars Materials

Approved Products

In highly regulated markets, biosimilars will be approved based on robust data packages that demonstrate similar patient efficacy, safety, and immunogenicity profiles as reference products.¹

Distinct nonproprietary names and transparent labeling are fundamental for appropriate use and prescribing.¹

Biosimilar development is a highly skilled, multistep process and requires extensive understanding of the reference product.¹

Matching biological function and critical quality is the art of biosimilar development.¹

Creating and selecting a promising clone from thousands of cells requires thorough understanding of the reference product and deep scientific capabilities.¹

Robustly designed clinical trials are important for regulatory approval, to inform treatment decisions, and to help instill confidence.¹

Robust analytical, non-clinical, and clinical data will be reviewed to understand the level of similarity of a proposed biosimilar.¹

Manufacturing biologics is a complex process.¹

Manufacturer process changes ≠ biosimilar development.¹