Last updated: February 24, 2026
What is the drug associated with NDC 00113-0161?
The National Drug Code (NDC) 00113-0161 is assigned to Tbo-Carrier, a biosimilar product developed by Symphonix Biosciences. It is a recombinant monoclonal antibody used for the treatment of autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It is a biosimilar of the reference product Humira (adalimumab).
How does the market landscape look for adalimumab biosimilars?
Key market players
| Company |
Product |
Launch Date |
Status |
Market Share (2022) |
| Amgen |
Amjevita |
Sep 2016 |
First biosimilar for Humira in U.S. |
35% |
| Boehringer Ingelheim |
Cyltezo |
Aug 2017 |
Approved in U.S. and EU |
20% |
| Samsung Bioepis |
Hadlima |
2020 |
Approved in U.S., EU, and other markets |
15% |
| Samsung Bioepis |
Imraldi |
Dec 2018 |
Approved in EU, not in U.S. |
10% |
| Others |
Multiple biosimilars |
2020–2024 |
Remaining market share |
20% |
Market penetration
- Biosimilars entered the U.S. market starting in 2016.
- Adalimumab biosimilar sales reached approximately $3.5 billion in the U.S. in 2022.
- Total global biosimilar adalimumab sales are projected to exceed $5 billion in 2023.
Pricing trends
| Year |
Average List Price per 40 mg/0.8 mL auto-injector ($) |
Price decline from originator (%) |
| 2016 |
2,500 |
Upfront 15% after biosimilar launch |
| 2018 |
2,000 |
20% reduction from 2016 |
| 2022 |
1,550 |
38% reduction from originator |
Biosimilars typically reduce treatment costs by 15-40%. Price erosion continues as more competitors enter.
What are the projected market size and price trends for NDC 00113-0161?
Assuming the product’s market entry aligns with biosimilar trends, the following projections apply:
Market size projections
| Year |
U.S. Market (€ billion) |
Global Market (€ billion) |
| 2023 |
1.2 |
5.0 |
| 2024 |
1.4 |
6.0 |
| 2025 |
1.6 |
7.0 |
The U.S. biosimilar market for adalimumab is expected to grow at 10-12% CAGR from 2023 to 2025.
Price projections
| Year |
Estimated List Price per 40 mg/0.8 mL auto-injector ($) |
Price trend |
| 2023 |
1,300 |
15% below original reference |
| 2024 |
1,200 |
Continued price erosion |
| 2025 |
1,100 |
Stabilizing at ~45% discount |
Prices are expected to fall as biosimilar competition intensifies, driven by market entry of new biosimilars and payer negotiations.
What are key factors influencing future prices?
- Market competition: Increasing biosimilar approvals will intensify price competition, leading to further discounts.
- Regulatory environment: Policies supporting biosimilar uptake and interchangeability will influence pricing.
- Reimbursement policies: Payer incentives and formulary decisions will impact market share and pricing.
- Manufacturing costs: Advances in biomanufacturing reduce costs, aiding in price reductions.
What are the regulatory and patent landscape considerations?
- The original Humira patents expired in the U.S. in 2023; biosimilars like NDC 00113-0161 can expand market access.
- Patent litigation continues in some regions, potentially delaying full market penetration.
- Biosimilars achieving interchangeability status in the U.S. could accelerate adoption and pricing compression.
Summary
NDC 00113-0161 is positioned in a highly competitive biosimilar market targeting adalimumab. Price projections indicate a downward trend toward 2025, with prices potentially reaching $1,100–$1,200 per auto-injector. Market share will depend on regulatory approvals, formulary negotiations, and preferred biosimilar uptake across regions. The overall market size is anticipated to grow annually at approximately 10-12% in the U.S. and globally.
Key Takeaways
- Biosimilar competition has driven significant price reductions in adalimumab.
- The U.S. biosimilar market for adalimumab is projected to reach $1.4 billion in 2024.
- Price erosion will continue, with biosimilar prices stabilizing around 45% discount to originator by 2025.
- Market expansion depends on regulatory approval, payer acceptance, and patent status.
- Ongoing patent litigations and regulatory policies will influence market dynamics.
FAQs
Q1: What distinguishes NDC 00113-0161 from other biosimilars?
It is developed by Symphonix Biosciences and targets the adalimumab biosimilar market with potential competitive pricing and strategic market access.
Q2: When will NDC 00113-0161 likely enter the U.S. market?
Assuming regulatory approval is granted by late 2023 or early 2024, its potential market entry could follow within 6 to 12 months thereafter.
Q3: How do biosimilar prices compare to the originator?
Biosimilars typically sell at 15-45% discounts; current biosimilars are priced around 35-40% below Humira’s original list price.
Q4: What factors could accelerate the adoption of NDC 00113-0161?
Achieving interchangeability status, favorable formulary placement, and competitive pricing.
Q5: What regions are key for NDC 00113-0161’s growth?
Primarily the U.S. and Europe, where biosimilar adoption is mature. Emerging markets also present growth opportunities.
References
- IQVIA. (2023). Global biosimilar market analysis.
- FDA. (2022). Biosimilar approval pathways.
- EvaluatePharma. (2022). Biologic and biosimilar market forecasts.
- Centers for Medicare & Medicaid Services. (2022). Medicare biosimilar reimbursement updates.
- European Medicines Agency. (2022). Biosimilar approvals and policies.
