Regions
MAIN/REGIONS
regions/
Regions
  1. Americas
  2. Asia & Oceania
  3. Europe
  4. Middle East & Africa
  1. Solutions
  2. Insights
  3. Events
  4. Contact Us
MAIN/search
MAIN/Solutions
Solutions/
SOLUTIONS
  • Life Sciences Solutions
  • Healthcare Solutions
  • Medical Device and Diagnostic
  • U.S. Government
Life Sciences Solutions

Bringing together unparalleled healthcare data, advanced analytics, innovative technologies, and healthcare expertise to create intelligent connections that speed the development and commercialization of innovative medicines to improve patient lives.

Learn More
Life Sciences Solutions
Healthcare Solutions

Accelerate digital innovation to enable smarter decisions that reduce cost, modernize patient and consumer engagement, and improve health outcomes.

Learn More
Healthcare Solutions
Medical Device and Diagnostic Solutions

Your world is unique – and quite different from pharma. In the U.S., decision-making has shifted from individual physicians to integrated networks--GPOs, IDNs and payers. These groups have heightened the focus on proving your solution’s value, demanding outcomes analyses and putting pressure on pricing.

Learn More
Medical Device and Diagnostic Solutions
U.S. Government Solutions

For government agencies and organizations at every level—from federal or national to regional and local—Big Data can have a huge impact on public health.

Learn More
U.S. Government Solutions
MAIN/Insights
Insights/
U.S. PROGRESS POINT

A curation of IQVIA's best thinking on topics and trends driving change, disruption, and progress in the United States healthcare market.

LEARN MORE
U.S. BLOGS

Get the latest insights on our life sciences, healthcare, and medical technology solutions in the United States. Follow our blog today!

LEARN MORE

U.S. INSIGHTS LIBRARY

"Browse our library of insights and thought leadership.

LEARN MORE
MAIN/Events
Events/
ON-DEMAND WEBINARS

Visit our library of on-demand webinars.

LEARN MORE
UPCOMING EVENTS & WEBINARS

View our upcoming events and webinars.

LEARN MORE

FEATURED WEBINAR

"Top Issues for Pharma to Watch in 2022 and 2023

WATCH NOW
MAIN/Contact Us
Contact Us/
Blog
Now Trending: Biosimilars
U.S. Biosimilar Market Trends Roundup
Emily Yoon, Sr. Consultant, Global Pricing and Contracting, IQVIA
Jul 12, 2023

Biosimilars are the subject of daily headlines across U.S. newspapers, drug reports, podcasts, and social media. After nearly a decade of growth, the now mature U.S. biosimilar market is of prominent interest across the nation as industry experts forecast how biosimilars will improve health outcomes, reduce spending, and most interestingly, influence market access trends. Today’s U.S. biosimilar market is comprised of:

  • 40 FDA-approved biosimilars across 15 reference biologic products, also known as "originator” products.
  • Multiple biosimilars competing against one reference product (see Table 1 below).
  • 30 launched biosimilars, with an additional 10 expected to launch by the end of 2023.1

Table 1: Total number of FDA-approved biosimilars per reference product. Current as of 5/25/2023.2

Biosimilars compete with just 14% of biologics as most of the market is protected by exclusivity, a timeframe during which biosimilar approval is restricted.3 Some biosimilars launch in the U.S. market within a year of approval, while others face lengthy launch delays due to a variety of factors such as patent litigation, legal settlements, and manufacturing delays. Current examples include:

  • Celltrion’s Yuflygma received FDA approval in June 2023 as the 9th adalimumab biosimilar (i.e., Humira biosimilar) and is expected to launch in July 2023.4
  • In contrast, Amgen’s buzzworthy Amjevita received FDA approval in 2016 with its historic launch taking place nearly 7 years later, in January 2023.5
  • Erelzi, an Enbrel biosimilar manufactured by Sandoz, was also approved in 2016 though the product launch is not expected until 2029.5
  • In June of 2023, Johnson & Johnson settled patent litigation with Amgen regarding their Stelara biosimilar. The lawsuit allows FDA approval of the biosimilar in the second or third quarter of 2023, and the settlement delayed expected launch from late 2023 to “no later than January 1st, 2025.”6

The timeframe when a biologic originator loses exclusivity, a biosimilar is approved, and the biosimilar is launched is highly anticipated, followed, and discussed. But insight to market access trends is observed post-launch, particularly when multiple biosimilars enter the picture. Current trends and observations are shown in Figure 1 below:

Figure 1: U.S. Biosimilar market trends roundup, July 2023.

It is impressive to look back on the growth of both biologics and biosimilars in the U.S. Both innovation and legislation have provided effective treatments to patients faced with complex, chronic diseases. Additional biosimilar launches and approvals in the coming years are anticipated to offer even more clinical success to U.S. patients and continue to be a major influence on U.S. drug spending.

 

References

  1. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/biosimilars-in-the-united-states-2023-2027/iqvia-institute-biosimilars-in-the-united-states-2023-usl-orb3393.pdf
  2. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
  3. https://www.fda.gov/drugs/biosimilars/background-information-list-licensed-biological-products-reference-product-exclusivity-and
  4. https://www.centerforbiosimilars.com/view/fda-approves-celltrion-s-yuflyma-the-ninth-adalimumab-biosimilar
  5. https://www.amgenbiosimilars.com/commitment/2022-Biosimilar-Trends-Report
  6. https://www.reuters.com/business/healthcare-pharmaceuticals/amgen-settles-jj-patent-lawsuit-over-drug-similar-blockbuster-stelara-2023-05-23/
  7. https://www.iqvia.com/locations/united-states/library/white-papers/lessons-from-semglee-early-perspectives-on-pharmacy-biosimilars
  8. https://drugchannelsinstitute.com/products/industry_report/wholesale/

IQVIA Global Pricing & Contracting

Our GPC team is your “one-stop-shop” for business and technology solutions for your global business.

CONTACT US

Related solutions

Market Access

Gain high value access and increase the profitability of your brands

Contact Us