Behind KANJINTI®

ANSWERING THE GROWING
NEED FOR BIOSIMILARS

At Amgen, we’re committed to the development of biosimilars because of the additional treatment options they provide to patients and the positive impact they can have on the entire health care system.

HERITAGE

With KANJINTI®, Amgen continues our dedication to oncology treatment and care

AMGEN Biologics – over 40 years of experience AMGEN Biologics – over 40 years of experience
  • For four decades, Amgen has been at the forefront of biologic innovation with the discovery, development, and production of novel medicines and support services for patients with cancer.
AMGEN® Biosimilars

HERITAGE To learn more about Amgen’s heritage in biologics and biosimilars, visit AmgenBiosimilars.com.

Amgen Biosimilars

EXPERTISE

Manufacturing quality biosimilars, like KANJINTI®, takes experience and expertise

Over 300 Quality Checks During Manufacturing Over 300 Quality Checks During Manufacturing
  • Amgen Biosimilars are developed to the same high standards as our innovative biologics.
  • Our rigorous processes are designed to ensure
    batch-to-batch consistency, quality, safety, and compliance with FDA regulatory requirements.
  • A rigorous approach
    to establishing biosimilarity2-4

    The FDA requires a totality of evidence to establish similarity.2

    • Establishing molecular similarity is the foundation of demonstrating biosimilar totality of evidence.2
    • The goal of biosimilar trials is to confirm no clinically meaningful differences between the biosimilar and reference drug.2

    How development goals differ

    Biosimilar Drug Development Biosimilar Drug Development

    For more educational information on biosimilars, visit BioEngage.


Setting A RIGOROUS STANDARD for Biosimilar Manufacturing

  • Manufacturing biosimilars, like KANJINTI®, is a complex process that requires custom cell lines, new manufacturing processes—and considerable expertise.2,3
  • Amgen is well positioned to address these complexities, by setting rigorous quality standards for all of our products.
The analytical similarity of KANJINTI® to the reference drug was established through 100 attributes across 40 assays The analytical similarity of KANJINTI® to the reference drug was established through 100 attributes across 40 assays
  • Biosimilars are complex4

    INcreasing complexity and development costs5

    Difference Between Generics and Biosimilars Difference Between Generics and Biosimilars

    Da = Dalton, 1 atomic mass unit; mAb = monoclonal antibody.

    For more educational information on biosimilars, visit BioEngage.

AMGEN® Biosimilars

EXPERTISE To learn more about Amgen’s expertise in biologics and biosimilars, visit AmgenBiosimilars.com.

Amgen Biosimilars
BioEngage

To learn more about biosimilars, visit AmgenBiosimilars.com/
BioEngage.

Amgen Biosimilars

Commitment

Amgen has an unwavering commitment to deliver our
products, including KANJINTI®, to every patient, every time

In the last decade, AMGEN® has achieved zero supply shortages
  • Our extensive manufacturing and distribution network helps ensure patients can get the medicines they need.
  • Every manufacturing facility strictly adheres to the same processes and quality-control measures.
  • We invest heavily in risk mitigation on all levels to ensure supply and product integrity.
AMGEN® Biosimilars

Commitment To learn more about Amgen’s commitment to serve patients, visit AmgenBiosimilars.com.

Amgen Biosimilars

Support

With both Amgen Assist 360™ and Amgen FIRST STEP™ programs available for our biosimilars, you’ll see the same support you've come to expect from Amgen.

Learn how Amgen uses the same support programs
for KANJINTI® as we do for our innovative treatments.

btn-medi_rainbow-svgsupport
amgen-oncology_logo

To stay up-to-date on Amgen’s advances in oncology, visit AmgenOncology.com.

Amgen Biosimilars