Solid Foundation Vital To Success Of U.S. Biosimilars Market

During the second half of 2014, the world noted the announcements of the first two — of hopefully many — applications to the U.S. Food and Drug Administration (FDA) for a new class of drugs called biosimilars. It’s expected that the FDA will begin to approve these applications in 2015, which means that, by the end of next year, American patients suffering from illnesses such as chronic kidney disease and cancer may be able to receive biosimilar drugs as part of their treatment.

A biosimilar is a biologic medication that is approved by regulators to be as safe and effective as the originator biologic drug it is modeled after. Because of the competition biosimilars will bring to the market, they offer significant cost savings to the expensive originator biologic. Previous estimates show that the U.S. Federal Government could save tens of billions of dollars in the first decade that biosimilars are introduced.[1]

These drugs and their benefits are no longer a hypothetical question for patients, as there has been more than eight years of safe and effective experience with biosimilars in Europe and biosimilars are officially coming to the U.S. market. Patients and the U.S. healthcare system are primed to reap the cost-savings biosimilars have to offer; however, we must create a market that supports biosimilars adoption and growth. This market must be underscored by the confidence the physician and patient should have based on the approval and support of the FDA.

While the FDA has been issuing draft guidelines for the industry regarding implementation of an “abbreviated” approval pathway for biosimilars since February 2012, the regulatory landscape for U.S. biosimilar products continues to evolve. Once the first approvals begin to occur, there will be enhanced public awareness and we will see adoption increase as physicians and patients realize the clinical and economic value these drugs bring. What is clear is that, to see the full benefit of biosimilars, there remains work to be done by all stakeholders before these treatments hit the market.

For truly widespread, effective adoption of biosimilars, it is paramount that the various regulatory agencies in the U.S. government fully prepare the ground for their arrival, particularly when it comes to providing fact-based public education about the safety and efficacy of these critical drugs.

— Naming: European practice and experience in naming biosimilars starts from a premise that biosimilars will have the same international non-proprietary names (INNs) as their reference biologics because they are all versions of the same active ingredient, separate from any naming qualifier. In addition to this INN, the drug prescribed has a unique brand name that distinguishes one version from another. Regulators and U.S. policymakers need to draw from nearly a decade of established international experience with biosimilars and implement the World Health Organization’s (WHO) position on maintaining the same INN for both biosimilars and originator biologics. By giving biosimilars the same INNs as their reference biologics, regulators can best ensure patient safety and accessibility to these medicines.

— Coding and Reimbursement: As the FDA prepares to take action on the first biosimilar applications in the United States in the           coming months, other federal agencies, including the U.S. Department of Health & Human Services (HHS) along with its Centers for Medicare & Medicaid Services (CMS), have an important role to play.  Biosimilars represent a significant opportunity for patients and payers, both private and public, in terms of cost savings and increased drug choices.  We believe that a clear regulatory framework for biosimilar reimbursement and coding will be critical to their success in the United States.  This framework needs to be clear, in advance of biosimilar approval, to provide for a smooth rollout so that health service systems do not struggle with payment systems when biosimilars are approved.  Such clarity will also help to ensure the full potential for cost savings, as well as a sustainable biosimilars market.

In addition to ensuring a positive regulatory market for biosimilars, we must create a climate of public awareness and confidence for patients and healthcare providers. Providers should be informed about the strong track record and extensive studies conducted to ensure the safety, efficacy and quality of biosimilars to get approval by the FDA. As with the introduction of generics 30 years ago, provider education is key. Hospira’s experience in Europe providing biosimilars for nearly the last seven years suggests that once physicians are aware of the extensive clinical efficacy and safety data, they gain confidence in prescribing biosimilars to their patients.

For U.S. patients and the healthcare system to fully benefit from the introduction of biosimilars and harness the projected $250 billion in total savings they will engender in their first decade on the market, it is vital for key stakeholders to lay a solid foundation for their introduction.[2] Hospira, leveraging our experience as the only North American-based producer of biosimilars in Europe and Australia, is committed to working with regulators and providers to create a strong marketplace within a robust regulatory framework for biosimilars, ensuring patient and prescriber confidence while allowing the U.S. healthcare system to fully realize the value of these profoundly powerful treatments.



Sumant Ramachandra, M.D., Ph.D., M.B.A., serves as Senior Vice President and Chief Scientific Officer for Hospira, Inc., the world’s leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars.


[1]  Congressional Budget Office. S. 1695 Biologics Price Competition and Innovation Act of 2007, 110th Cong. Available at: Accessed December 9, 2014

[2] Miller, S. The $250 Billion Potential of Biosimilars. Express Scripts April 23, 2013:

Morning Consult