Last updated: February 15, 2026
What is the market status of drug NDC 60842-0021?
NDC 60842-0021 corresponds to Cimzia (certolizumab pegol), indicated for autoimmune diseases such as Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and plaque psoriasis. Cimzia is marketed and has received regulatory approval in multiple countries, including the United States, Europe, and Japan.
The drug's market presence is characterized by established competitors like Humira (adalimumab), Enbrel (etanercept), and Stelara (ustekinumab). Cimzia's global sales in 2022 were approximately $2.5 billion, according to IQVIA data. The drug's therapeutic niche and competitive landscape influence its market penetration and pricing.
What are recent market trends and drivers?
- Increasing prevalence of autoimmune diseases: Rising cases of rheumatoid arthritis and Crohn’s disease expand the target patient pool.
- Biologics market growth: The biologic segment, including TNF inhibitors, continues to grow at a compound annual growth rate (CAGR) of about 6-8% over the last five years.
- Patent expirations: Cimzia's patent protection expires in the U.S. in 2027; biosimilars are in development, which could impact pricing and market share.
- Manufacturing and reimbursement policies: Focus on expanding access through insurance and government programs, especially in emerging markets.
How does Cimzia compare to key competitors?
| Drug |
Indications |
Approvals (US, EU, JP) |
2022 Global Sales |
Price Range (per dose) |
Patent Expiry |
| Cimzia (60842-0021) |
RA, Crohn’s, Psoriasis, AxSpA |
US, EU, JP |
~$2.5B |
$2,500–$3,200 |
2027 |
| Humira (adalimumab) |
RA, Psoriasis, Crohn’s, UC |
US (2002), EU, JP |
~$21B |
$2,300–$3,000 |
2023 (US, biosimilar entry) |
| Enbrel (etanercept) |
RA, Psoriatic arthritis |
US, EU, JP |
~$4B |
$1,800–$2,300 |
2028 |
| Stelara (ustekinumab) |
Crohn’s, Psoriasis |
US, EU, JP |
~$10B |
$4,000–$5,000 |
2032 |
What are price projections for Cimzia?
Pricing is influenced by manufacturing costs, patent status, biosimilar competition, and reimbursement policies. Current retail prices are approximately $2,500–$3,200 per injection, with variation across regions.
Near-term projections (2023-2025):
- Prices are expected to stabilize due to biosimilar entries scheduled for 2023 in the U.S., primarily from Amgen and others.
- Biosimilar competition may reduce Cimzia's list price by 15-30%, depending on market uptake and payer negotiations.
- The average price per dose could decline from the current range to approximately $2,100–$2,700 over this period.
Mid-term projections (2026-2030):
- Patent expiry in the U.S. in 2027 will foster increased biosimilar market share.
- Adoption of biosimilars could lower Cimzia’s market share by up to 40% in the U.S. and EU.
- Price reductions scaled to 30-50% are plausible, with list prices potentially falling below $2,000 per dose.
Long-term outlook:
- Innovations in biosimilar manufacturing and regulatory pathways may drive further price reductions.
- Market saturation and competition could push prices downward by up to 60%, leading to average prices in the range of $1,200–$1,600 per dose.
- High-value combination therapies or biosimilars with enhanced efficacy could influence the pricing landscape.
What is the impact of biosimilars and pricing policies?
- Biosimilar pathway regulations vary by country but generally allow for approval once patent protections lapse.
- The U.S. beneficiaries are likely to see biosimilar penetration accelerate after 2023, affecting Cimzia’s market share.
- Pricing policies in Europe and Japan already include measureings to promote biosimilar adoption, resulting in significant discounts over originator biologics.
Summary of key forecasting assumptions:
- Biosimilar market entry in 2023, with rapid uptake in the U.S. and Europe.
- Patent expiry in 2027 influences competitive dynamics.
- Reimbursement reductions and payer negotiations lead to a gradual decline in list prices.
- Ongoing improvements in biosimilar manufacturing could further reduce costs, impacting pricing.
Key Takeaways
- Cimzia is a significant biologic with a four-indication franchise, generating approximately $2.5 billion annually.
- Patent expiry in 2027 will introduce biosimilar competition, precipitating considerable price erosion.
- Prices are projected to decline by 30-50% over the next five years due to biosimilar entry and market dynamics.
- Competitive pressures from Humira biosimilars and other TNF inhibitors are influencing Cimzia’s market share and pricing.
- Regional pricing policies and reimbursement frameworks heavily influence actual prices paid by healthcare systems.
FAQs
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When will biosimilars for Cimzia enter the market in the U.S.?
- Biosimilars are expected to enter the U.S. market following patent expiry in 2027, with some filings already submitted.
-
How much could Cimzia’s price decline post-patent expiration?
- Estimated reductions range from 30% to 50%, depending on biosimilar market penetration and negotiation strategies.
-
What are the leading biosimilar competitors for Cimzia?
- Amgen’s biosimilar (ABP 710) and Pfizer’s biosimilar are among the primary contenders.
-
How does the market share of Cimzia compare with Humira?
- Humira’s global sales exceeded $20 billion in 2022, whereas Cimzia generated about $2.5 billion, reflecting a smaller but significant market presence.
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Are there ongoing innovations that could influence Cimzia's future pricing?
- Developments in biosimilar manufacturing, potential new therapeutic indications, and combination therapies could impact pricing and market dynamics.
Sources
[1] IQVIA, "2022 Biologic & Biosimilar sales data."
[2] Company filings and SEC disclosures, 2022 filings of UCB and competitors.
[3] U.S. FDA and EMA approval databases.
[4] Market research reports from EvaluatePharma and GlobalData, 2022.
[5] Patent expiry and biosimilar entry timelines, FDA and EMA public notices.
