Biosimilars

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 world^6,7
• Amgen helped demonstrate the clinical and pharmacoeconomic value of biosimilars across multiple therapeutic areas with high-quality medicines that have helped reduce overall treatment costs^6,7
• Healthcare practices and systems around the world may apply savings realized with Amgen Biosimilars to offset budget pressures from COVID-19 and related illnesses^8-10

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 leader^12,13
• 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 2007^1,2
• 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.

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.

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 needs^3,4

Citations: 3. KANJINTI^® (trastuzumab) PM. 4. AMGEVITA^TM (trastuzumab) PM.

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 discharges^6,8
• 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. AMGEVITA^TM (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 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

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.