Biosimilar Uptake in the US

What's going on?

Ten years have passed since Congress established a statutory pathway for approval of biosimilars, the Biologics Price Competition and Innovation Act (BPCI Act) in 2009.1 Since then, the FDA has approved 17 biosimilar drugs, but of those, only a handful are commercially available.2,3* This delay in availability and commercialization is mainly due to patent litigation (ie, patent disputes beyond the traditional loss of market exclusivity).4 And the delays are costly.5
*As of February 2019.

People Behind the Promise

Get industry insiders’ perspectives on relevant topics with this regular video feature.

Meet Molly Burich, Director of Public Policy: Biosimilars and Reimbursement, and hear her discuss biosimilar uptake in the US.

“I would say we're in the early days... so we have to give it time to let the market fully develop.”
“I would say we're in the early days... so we have to give it time to let the market fully develop.”

People Behind the Promise
is a regular feature of BIOSIMILAR PERSPECTIVES

Future topics and speakers include:

The Complexity of
Manufacturing Biologics & Biosimilars
with Mark Langston, Head of Marketing,
Executive Director,
Biosimilars at Boehringer Ingelheim
Manufacturers, Payers,
and the Biosimilar Market
with Tom Koenig, Executive Director Biosimilar Market Access at Boehringer Ingelheim
Biosimilars and Sustainability
of the Healthcare System
with Molly Burich, Director of Public Policy: Biosimilars and Reimbursement at Boehringer Ingelheim

Biosimilar uptake in the US

So what’s happening with the biosimilars that have made it to market in the US?

Slow Start

In contrast to the European Union, where biosimilar uptake has been growing, the US market has not seen similar adoption.7,8

While the US accounts for 59% of the global biologic medicine sales, it has only 2-3% of global biosimilar sales. Whereas the European Union, which represents 22% of biologic
sales, has 87% of global biosimilar sales.6

Even factoring in the time lag (biosimilars have been available in the EU since 2006), uptake in the US has not been robust.8,9 For example, after a little over a year, Pfizer’s infliximab biosimilar had captured only 6% of the market.10

As of Q4 2017.
Insulins and other associated products will transition to be considered 351a (biologics) or 351k (biosimilars) in March 2020 per the Affordable Care Act requirement.12

So, why has biosimilar adoption in the US been so much slower than in the EU?
It generally comes down to two major factors:13,14

  • Misinformation around biosimilar effectiveness and safety
  • Brand biologics manufacturers' contracting practices and lifecycle management strategies to protect market share

FDA Helping to Address Misinformation

As with any new treatment area, education is a necessity. In recognition of this, as part of the 2018 FDA Biosimilar Action Plan (BAP), the FDA has released numerous patient and prescriber outreach materials, including a series of five videos and fact sheets that cover topics from the basics to the intricacies of biosimilar development and the establishment of interchangeability.15

“The policy and regulatory decisions that we make today are going to have a lot to do with whether we realize the promise [of biologics]... Or if we see the opportunities we once envisioned go unrealized.” 5
FDA Commissioner Scott Gottlieb, July 2018
Growing Recognition by Professional Societies
In addition, medical professional societies have taken up the mantle of biosimilars. “We are now confident that providers can recommend biosimilars as a safe, effective, and affordable option to patients, where appropriate,” said Dr. S. Louis Bridges, Jr., MD, PhD, chair of The American College of Rheumatology Committee on Research, in a white paper published in February 2018.16
Similarly, in April 2018 the American Society of Clinical Oncology issued a statement regarding the use of biosimilars: “To enhance patient and provider confidence in biosimilars, it is necessary to educate oncology providers and continue to advocate for federal and state policies that ensure the efficient approval, unrestricted access, and appropriate use of biosimilars.”17

FDA Taking Steps to Promote Competition and Patient Access

With so much at stake, reference biologic manufacturers may take multiple steps to protect market share. Some tactics may include contract “bundling” and volume-based rebate strategies that lock up payers in multi-year contracts to deter biosimilar entry.5 And payers have been cited by FDA for requiring step therapy or prior authorization on the reference biologic before patients can access a biosimilar, despite the fact that a biosimilar must demonstrate, among other things, that it has no clinically meaningful differences from the reference product.5

In response to these practices, the FDA has pledged to “take action, whenever necessary, to reduce gaming of current FDA requirements, and coordinate with the Federal Trade Commission to address anti-competitive behavior.” 5

  1. 1. US Food & Drug Administration website. Biosimilars are safe, effective, treatment options.  Process/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm. Accessed Feb  4, 2019.
  2. 2. US Food & Drug Administration website. Biosimilar product information.  DrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580432.htm. Accessed Feb 4, 2019.
  3. 3. Center for Biosimilars website. The complete guide to monoclonal antibody and granulocyte-colony stimulating factor biosimilars approved  in the United States and European Union. Accessed Feb 25, 2019.
  4. 4. Siegel JF, Royzman I. US biosimilar approvals soar in 2017. Biologics Blog.  als-soar-in-2017. Accessed Feb 4, 2019.
  5. 5. US Food & Drug Administration website. Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings  Institution on the release of the FDA’s Biosimilars Action Plan. ments/ucm613881.htm. Accessed Feb 4, 2019.
  6. 6. QuintilesIMS. Market development in Europe and globally: MAT Dec 2016. Available at: IGBA Medicines website. doc/Module6.pdf. Accessed Feb 4, 2019.
  7. 7. Chen Y, Dikan J, Heller J, Santos da Silva J. Five things to know about biosimilars right now. McKinsey website. industries/pharmaceuticals-and-medical-products/our-insights/five-things-to-know-about-biosimilars-right-now. Accessed Feb 4, 2019.
  8. 8. IQVIA website. outlook-to-2022.pdf. Accessed Feb 4, 2019.
  9. 9. Frank RG. Friction in the path to use of biosimilar drugs. NEJM. 2018;378(9):791-793.
  10. 10. Davio K. Pfizer execs underscore the need for a level playing field for biosimilars. Center for Biosimilars website. https://www.centerforbiosi Accessed Feb 4, 2019.
  11. 11. Data on file, Boehringer Ingelheim.
  12. 12. US Food & Drug Administration website. Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and  Innovation Act of 2009. Published December 2018. Guidances/UCM490264.pdf. Accessed Feb 6, 2019.
  13. 13. American Journal of Managed Care website. Current Market and Regulatory Landscape of Biosimilars.  journals/supplement/2018/managing-costs-advancements-biosimilars/current-market-and-regulatory-landscape-of-biosimilars. Accessed  Feb 4, 2019.
  14. 14. Cohen J. What's Holding Back Market Uptake Of Biosimilars? Forbes website. whats-holding-back-market-uptake-of-biosimilars/#21997852691a. Accessed Feb 4, 2019.
  15. 15. US Food & Drug Administration website. Patient and Prescriber Outreach Materials. Process/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580435.htm.  Accessed Feb 4, 2019.
  16. 16. The American College of Rheumatology website. American College of Rheumatology Recommends Biosimilar Use in New White Paper. Accessed Feb 4, 2019.
  17. 17. Lyman GH, Balaban E, Diaz M, et al. American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol. 2018;36:1260-1265.