Amgen continues to prove the value it brings to the
healthcare community as a
biosimilars leader since 2017
- Amgen’s industry-leading portfolio of biosimilars has
already been
successfully adopted in both acute and chronic settings
around the
world6,7
- Amgen helped demonstrate the clinical and
pharmacoeconomic value of
biosimilars across multiple therapeutic areas with
high-quality medicines
that have helped reduce overall treatment
costs6,7
- Healthcare practices and systems around the world may
apply savings realized
with Amgen Biosimilars to offset budget pressures from
COVID-19 and related
illnesses8-10
Every aspect of experience Amgen gained in the last four
decades has been
applied to the way it provides treatment with its
biosimilars
- Amgen biosimilar programs are designed to provide robust
data—often
exceeding minimum regulatory requirements11
- Amgen’s biosimilars clinical development programs are
designed to generate
robust and rigorous data, not only to obtain regulatory
authority approval,
but also to provide patients, physicians, and payers
with robust information
so that informed treatment choices can be made with
confidence11
As a biosimilars leader, Amgen strives to make a profound
impact in the lives
of healthcare professionals and patients while seeking
to lighten the cost
burden for healthcare systems
- The first therapeutic biosimilars in oncology were
developed and supplied by
Amgen—further advancing its role as a category
leader12,13
- Amgen aims to help customers serve the greatest needs in
healthcare, as
demonstrated with 3 of its biosimilars that are listed
on the World Health
Organization’s Model List of Essential
Medicines14
Amgen is focused on what matters most by helping
healthcare professionals
address the greatest healthcare needs through
industry-leading standards in
product quality and support
- The Amgen biosimilar portfolio is built on a foundation
of exceeding
customer expectations with an unmatched level of product
knowledge and
support, both in person and virtually
- Amgen Field Representatives are highly trained and bring
years of experience
from supporting healthcare professionals in various
therapeutic areas
Citations: 1. Amgen Letter to Shareholders, 2018.
2. Health Canada.
Biologics, Radiopharmaceuticals and Genetic Therapies.
Accessed August 27, 2018.
Available at:
https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies.html
3. About Amgen Fact Sheet,
wwwext.amgen.com/~/media/amgen/full/www-amgen-com/downloads/fact-sheets/fact_sheet_amgen.ashx.
4. Amgen Press release: Update On Hurricane Maria,
www.amgen.com/newsroom/press-releases/2017/09/amgen-provides-update-on-hurricane-maria
5. Products, www.amgen.ca/products. Accessed February
16, 2022. 6.
Amgen Biosimilars, FDA-Approved products,
https://www.amgenbiosimilars.com/products/approved-products
7. DOF,
Patients Worldwide, 2021. 8. Ableson R. New York
Times, 5/5/20. 9.
Ableson R. New York Times. 5/9/20. 10. DOF, WAC and
ASP, 4/21 11.
USFDA, Scientific Considerations in Demonstrating
Biosimilarity to a Reference
Product, 4/15 12. KANJINTI®
(trastuzumab) PM. 13.
MVASI® (bevacizumab) PM. 14. WHO 21st
list, Model list of
essential medicines, 2019.
www.who.int/publications/i/item/WHOMVPEMPIAU2019.06
Amgen has a nearly unmatched supply reliability record,
fulfilling its promise
to deliver its treatments to every patient, every
time
- There have been 0 SUPPLY SHORTAGES for Amgen products,
including
biosimilars, in more than a decade since
20071,2
- Amgen’s approach to providing a continuous supply of
biologic therapies has
four key elements: prevention, technology, inventory
management, and
redundant manufacturing to try and ensure that our
patients have access to
their critical medications on time
- PREVENTION includes promoting exemplary
regulatory compliance,
robust quality-management processes, operational
excellence, supply
chain security, infrastructure investments, and
business continuity
planning
- TECHNOLOGY to enhance product purity and the
robustness of the
manufacturing process
- INVENTORY MANAGEMENT to help us have the right
quantities of the
product housed in diverse geographic locations
- REDUNDANT MANUFACTURING capacity in multiple
geographic locations
and backup suppliers for raw materials
Amgen rose to the challenge of COVID-19 because that’s
what the healthcare
community should expect from a marketplace leader
- Nearly 300,000 commercial deliveries of Amgen products
were completed within
the first 5 months of the pandemic
- Automated monitoring/intervention systems were set up to
secure
direct-to-patient supply for commercial and
investigational medicines
- Proactive increases of commercial and clinical product
inventories, and the
materials needed to manufacture them, strengthened
supply/distribution
chains and ensured timely product delivery
Citations: 1. Data on file; 2018. 2. Data on file;
2020
