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Amgen’s over 4 decades of experience demonstrates that it can be relied on to provide industry-leading treatments and customer service

INFRASTRUCTURE NETWORKS

Amgen is uniquely positioned to provide exceptional value today and long into the future with industry-leading capabilities

  • Amgen has spent over 40 years building a dependable global network of scientists, manufacturing, and distribution facilities
  • Amgen upholds rigorous quality control measures throughout the manufacturing process and has placed key facilities in North America and Europe*1

*May differ by product.

Biologics development is a highly complex, multistep process2—and Amgen has experience in all phases, from development to manufacturing, to ensuring a reliable supply.

Biosimilars development is equally complex, and our biologics expertise, gathered over four decades, means that we’re prepared for the task. We use the same processes, scientific standards, and quality systems for our biosimilars as we do for our innovator biologics

Amgen achieved its reputation with a rich history pioneering the biotechnology sector

  • Amgen has successfully discovered and delivered innovative, life-changing medicines across therapeutic areas like inflammation and oncology since 1980

The healthcare community recognizes Amgen as a premier biotech that can meet the complex needs of both patients and healthcare professionals

  • Patients and healthcare professionals are served by Amgen in 50+ countries3

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.

PLANNING

Delivering medicines to every patient, every time is more than a promise Amgen makes—it’s who we are

  • The comprehensive risk mitigation strategies that Amgen has put in place to support reliable manufacturing/supply were developed and refined over decades of real-world experience
  • Even in times of crisis, Amgen employees have risen to some of the world’s most difficult challenges to support our customer needs4
  • Amgen invests in alternative sources of supply to help meet customer demand regardless of unexpected manufacturing hurdles4

The world-class approach Amgen takes to biologic medicines has been tested and proven effective over the years through complex circumstances

  • Amgen’s preparation and experience have allowed it to exceed customer expectations in even the most challenging of circumstances, such as maintaining supply through Hurricane Maria and during the COVID-19 pandemic—we always strive to get our medicines to every patient, every time4
  • Amgen has a manufacturing and distribution presence in over 100 countries to adapt to shifting geographical needs and circumstances3

Citations: 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

THERAPEUTIC AREA & INNOVATOR EXPERIENCE

Amgen earned its strong reputation as a biotechnology leader through a broad portfolio with real-world success

  • Amgen has successfully launched over 12 biologic medicines across multiple therapeutic settings5
  • For more than 40 years, healthcare professionals have been able to depend on Amgen when treating patients with complex and life-threatening diseases3

Citations: 3. About Amgen Fact Sheet, wwwext.amgen.com/~/media/amgen/full/www-amgen-com/downloads/fact-sheets/fact_sheet_amgen.ashx. 5. Products, www.amgen.ca/products. Accessed February 16, 2022.


Amgen's real-world experience and expertise have paved the way for its leadership in biosimilars

PROVEN EXPERIENCE

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

SUPPLY RELIABILITY

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.


Amgen considers the true measure of its success by staying ahead of emerging challenges people face in healthcare

 

PIPELINE

The Amgen Biosimilars pipeline has been carefully selected to address the greatest treatment needs without compromising the level of customer support

  • Amgen takes a synergistic approach to the biosimilar pipeline by developing new products that will be able to take advantage of established Amgen therapeutic area knowledge and customer support systems
  • Amgen is heavily invested in the long-term success of biosimilars with new pipeline molecules that were selected for their potential to lower costs associated with high-volume or high-priced treatments, as well as the ability to deliver value to the healthcare system1
  • Amgen has been exploring the full potential of biosimilars with a diverse pipeline across various therapeutic areas, including the first biosimilar in rare disease1

Amgen will continue pursuing new biosimilar treatment options to help maximize the way this essential treatment class benefits patients, and subsequently healthcare systems

  • Amgen has invested over $2Billion USD in its biosimilars program to achieve an ambitious goal of supporting healthcare resiliency in some of the most costly treatment areas2
  • Amgen is dedicated to developing a comprehensive portfolio of biosimilar and innovator biologic treatments to satisfy the broad range of clinical and pharmacoeconomic needs
  • Amgen continues to demonstrate its dedication to serve patients and the healthcare system by developing high-impact biosimilars for even complex, high-need therapeutic areas like rare disease1

Citations: 1. Amgen Pipeline. www.amgenpipeline.com/-/media/Themes/Amgen/amgenpipeline-com/amgenpipeline-com/PDF/amgen-pipeline-chart.pdf. 2. Winegarden W. Forbes, 2020.

SETTING STANDARDS

Amgen continues advancing the role of biosimilars by upholding the highest standards for the best possible customer experiences

  • Amgen strives to identify and understand barriers to biosimilar adoption so it can help patients and the healthcare community overcome them by providing a diverse array of education resources for both patients and healthcare professionals
  • Customer input is among the most influential factors in how Amgen approaches its role to best serve patients and the healthcare community
    • To address customer needs and reduce its environmental impact, Amgen is creating more efficient packaging for its biosimilar products.
  • Amgen will continue perfecting its approach to biosimilars by understanding how to best serve the healthcare community’s needs
  • Amgen has made specific development and manufacturing choices to provide non-clinical product-level advantages (like convenient vial size options, citrate-free formulations or patient-friendly autoinjector options) to better support customer needs3,4

Citations: 3. KANJINTI® (trastuzumab) PM. 4. AMGEVITATM (trastuzumab) PM.

HEALTHCARE RESILIENCE

Amgen is one of the only long-standing biotechnology leaders that continues to invest in healthcare innovation by developing both biosimilars and novel therapeutics that can help HCPs improve patient outcomes well into the future

  • Amgen biosimilars are contributing to healthcare resiliency by increasing competition against reference drugs and other biosimilars without compromising on quality, efficacy, or patient safety
  • Amgen biosimilars’ support of healthcare resiliency can help battle the secondary health crisis and management of overall chronic disease due to COVID-19 by potentially helping free up resources for HCPs to intervene earlier, screen appropriately, and drive programs that can improve patient outcomes before they become debilitating2
  • At a time when healthcare costs are rising, we aspire to contribute to a more sustainable healthcare system. Our goal is to provide biosimilar options that can offer cost savings to patients and the healthcare system

Amgen extends its commitment to serving the public good through its products as well as its business decisions by partnering with suppliers who promote sustainability

  • Amgen has adopted a Conflict Minerals Policy that established its objectives and goals to eliminate conflict minerals from its supply chain5
  • The Environmental Protection Agency awarded Amgen with the Green Chemistry Award in 20176
  • Amgen contracts and operates > 90% of meetings at hotels that have environmentally friendly practices, and maintains green practices during meetings7
  • Amgen was one of the first companies to send previously hard-to-recycle plastics for recycling into park benches and pallets7
  • Amgen employs safe practices for the handling, movement, storage, recycling, reuse, or management of waste, air emissions, and wastewater discharges6,8
  • A 33% reduction in carbon emissions has been realized from Amgen carbon-reduction projects since 2007, and Amgen has pledged to achieve carbon neutrality by 2027 6

Citations: 1. Amgen Pipeline. www.amgenpipeline.com/-/media/Themes/Amgen/amgenpipeline-com/amgenpipeline-com/PDF/amgen-pipeline-chart.pdf. 2. Winegarden W. Forbes, 2020. 3. KANJINTI® (trastuzumab) PM. 4. AMGEVITATM (trastuzumab) PM. 5. Amgen Conflict minerals policy. https://www.amgen.com/partners/suppliers/supplier-resources/conflict-minerals-policy 6. Amgen, Responsibility Highlights Report, 2017. 7. Amgen. www.amgen.com/responsibility/environmental-sustainability/case-studies/a-new-life-for-waste-plastics 8. Amgen, Supplier Code of conduct.


Amgen is dedicated to understanding its customers’ everyday needs to create helpful support resources that may set its biosimilars apart

RESOURCES & EDUCATION

Amgen has applied its 4 decades’ worth of experience supporting the healthcare community in different therapeutic areas to the creation of Amgen Biosimilars support resources

  • The Amgen team is dedicated to being there to help support customers with representatives who can visit the office, either in person or virtually depending on customers’ individual preferences
  • The same careful consideration that goes into Amgen innovator product support resources is applied to the offerings provided with its biosimilars for an individualized approach to patient care and simple transition
  • Amgen is committed to providing solution-oriented services and educational materials to help provide HCPs and patients with a positive biosimilars onboarding experience
  • Amgen strives to meet the individual needs of different patient populations and their caregivers—across disease states and age groups, including pediatrics—with tailored resources and services that can have meaningful impact on their care
  • Amgen strives to be a positive presence in its customers’ practices by helping to simplify the process of adopting its biosimilars and actively addressing their needs over time
  • Patient education resources are available from Amgen to help support healthcare practices while counseling patients to help optimize treatment outcomes

PROGRAMS

Amgen customers will find that our biosimilars receive the same level of support that is found with our innovator products

  • Available Amgen resources cover a wide range of patient support to help them access their treatments, including coverage determinations, reimbursement counselors, financial assistance options, and educational resources
  • Amgen has deep experience in different market environments (hospital, retail, private/public payers) to help its customers navigate their specific circumstances
  • Thousands of patients have enrolled in Amgen support programs to receive the full Amgen experience during their biosimilar treatment1
  • Click for more information about Amgen patient support programs in Canada
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Citations: 1. Data on File, Entrust Report 2021.


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