New White Paper Highlights Barriers and Opportunities to Drive Biosimilar Adoption in the United States

Biologic medicines are among the most innovative drugs to treat many life-threatening conditions, including cancer and autoimmune diseases.

  • Healthcare professionals can benefit from more education to address knowledge gaps about the FDA’s robust evaluation, review, and approval standards for biosimilars
  • Do prescribers and patients benefit enough from biosimilar cost savings? A customized approach to encourage biosimilar adoption is needed for each health institution, and the needs of different stakeholders, including prescribers and patients, should be considered as part of the whole package
  • Providing education well in advance of the transition process is the key to successful biosimilar adoption

INCHEON, Korea, Nov. 17, 2021 (GLOBE NEWSWIRE) -- Biologic medicines are among the most innovative drugs to treat many life-threatening conditions, including cancer and autoimmune diseases. Although biologic medicines represent only 2% of all prescriptions, they account for 43% of the total pharmaceutical spending in the United States.i This spending is expected to rise every year, as prices and use of biologic medicines continue to increase.

Currently there are 31 biosimilars approved by the U.S. Food and Drug Administration, and 21 of them are available to patients.ii,iii When first-generation biosimilars were introduced in the United States, there was much anticipation about biosimilars’ potential to be a solution to the rising cost of medicines. While the rate of biosimilar uptake is generally increasing over time, there are still barriers that are impeding adoption of biosimilars in the United States.

Samsung Bioepis Co., Ltd. today launched a new white paper entitled ‘Improving the Understanding and Acceptance of Biosimilars in the United States.’ The new white paper, developed based on research in 2021, highlights current perceptions, knowledge gaps, and barriers within the U.S. healthcare environment that are stymying adoption of biosimilars, and outlines potential strategies and incentives to help expand biosimilars’ use to help reduce healthcare costs while maintaining a high standard of patient care. The report is informed by the insights of key opinion leaders and subject matter experts, including doctors, pharmacists, nurses, patient advocates, and drug policy experts, who participated in three virtual expert panel sessions held in June-July 2021.

“Although healthcare providers understand the general premise of an abbreviated pathway for biosimilars, it feels different when they’re trying to make a prescribing decision, particularly when the comparative analytical data do not seem real to them because they do not fully understand the regulatory pathway.” – Federal Policy Expert

Key takeaways from the three expert panel meetings are:

1) Reducing information gaps: The level of understanding and acceptance of biosimilars varies among different stakeholders and even within stakeholder groups. The experts stressed that prescribers across all medical specialties need more education to address knowledge gaps about the stringent manufacturing standards and rigorous regulatory review process for biosimilars, as well as real-world data on extrapolated indications.

2) Incentivizing different stakeholders: Experts agreed that biosimilars bring cost saving benefits to the overall healthcare system, but also pointed out that those financial benefits may not trickle down to prescribers and patients. There is no “one-size-fits-all” solution, and manufacturers should customize their approach, including potential cost savings, as part of the package that is designed to meet the needs of different stakeholder groups.

3) Practical considerations for implementation: In addition to financial savings, there are non-financial factors that decision makers at each healthcare institution will consider as they decide whether to adopt particular biosimilars. These include manufacturers’ reputation and reliability with respect to providing high quality products without supply interruptions, products’ clinical and real-world data, and operational factors such as product labeling, electronic medical record (EMR) integration and inventory management. Best practices indicate the importance of education, especially providing information and education well in advance to give healthcare professionals and patients sufficient time to understand and accept the transition process.

“We are excited to share these insightful research findings on U.S. biosimilar adoption with stakeholders across the U.S. healthcare landscape. The white paper highlights some of the most critical barriers that are hindering wider access to biosimilars,” said Kyung-Ah Kim, Senior Vice President, Development Division Leader, Samsung Bioepis. She continued, “The U.S. health care market is complex and these are not the issues that can be solved in the short-term, but it is important that the discussion and collaboration continue among the FDA, industry, and professional and patient communities so that we can uncover the appropriate solutions and strategies that will help patients have better access to biosimilars in the U.S.”

The full version of ‘Improving the Understanding and Acceptance of Biosimilars in the United States’ can be downloaded at:

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing health care that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology, and gastroenterology. For more information, please visit: and follow us on social media – Twitter, LinkedIn.

Anna Nayun Kim
Samsung Bioepis

Anna Army

i IQVIA Institute. Biosimilars in the United States 2020-2024. Available at: Accessed November 2021.

ii U.S. Food and Drug Administration. Biosimilar Product Information. Accessed November 2021.

iii Xcenda. Biosimilar approval and launch status in US. Available at: Accessed November 2021.

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