Last updated: March 15, 2026
What is NDC 70677-0101?
NDC 70677-0101 corresponds to the biologic drug Glofitamab, a bispecific CD20xCD3 T-cell engaging antibody developed by Roche. It is designed for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Market Overview
Market Size and Revenue
The global DLBCL market exceeds $3 billion annually, with expanding indications and new therapies driving growth. Glofitamab entered clinical use in 2022, targeting a segment that includes:
- Patients with relapsed/refractory DLBCL
- Hematologic malignancies resistant to CAR-T therapies and other immunotherapies
Competition
Major competitors include:
| Drug Name |
Class |
Indications |
Market Approval Year |
Estimated Market Share (2022) |
| Roche's Glofitamab |
Bispecific antibody |
R/R DLBCL |
2022 |
10-15% |
| Genentech's Polivy |
Antibody-drug conjugate |
R/R DLBCL |
2019 |
35-40% |
| AbbVie's Venclyxto |
BTK inhibitor |
R/R DLBCL |
2017 |
15-20% |
| Other CAR-T products |
Cell therapy |
R/R DLBCL |
2017-2019 |
15-20% |
Glofitamab targets a niche but is positioned to expand its market share as an alternative to CAR-T therapies, especially for patients not eligible for or resistant to CAR-T.
Pricing Data and Projections
Current Pricing
- List Price (2023): Approximately $37,000 per dose
- Dosing schedule: 1.2 mg via IV infusion weekly for 4 weeks, then every 3 weeks
Cost for a Typical Treatment Course
- Total doses: 8-10
- Total estimated treatment cost: $297,000 – $370,000
Reimbursement Trends
Medicare and commercial insurers reimburse based on billing codes (e.g., Q5103), with average reimbursement around 85–90% of list price.
Price Trends
- Initial pricing set at launch (2022): $37,000 per dose
- Expected to decrease 5-10% in the next 2 years due to market competition and biosimilar entry after patent expiration (~2032)
- Potential discounts for broader adoption or hospital formulary inclusion
Future Price Projections
| Year |
Expected Price/Dose |
Key Factors |
| 2023 |
$37,000 |
Launch price |
| 2025 |
$33,300 |
Competitive pressures, rebate strategies |
| 2030 |
$28,000* |
Market saturation, biosimilar entry (~2032) |
*Projected based on historical biologic price declines of 3-5% annually.
Regulatory and Policy Impact
- Patent Lifecycle: Patent protections extend to 2032, delaying biosimilar competition.
- Pricing Policies: US pressure on drug prices could result in increased negotiations, rebates, or incentives to lower costs.
- Global Markets: Prices are typically lower outside the US, with emerging markets paying 40–70% less.
Key Takeaways
- Glofitamab is a targeted therapy for a high-value lymphoma segment, with an initial list price of around $37,000 per dose.
- The drug faces competition from established therapies, with pricing pressure expected to grow as biosimilar options mature.
- Total treatment costs hover around $300,000 per patient, making affordability and reimbursement critical.
- Price declines forecast at 5-10% over the next 2 years, aligned with market dynamics and biosimilar entry post-2032.
FAQs
Q1: What factors influence Glofitamab’s pricing?
Market competition, manufacturing costs, reimbursement negotiations, and patent protection impact its list price and discounts.
Q2: How does Glofitamab compare cost-wise to CAR-T therapies?
CAR-T therapies cost approximately $375,000 to $475,000 per treatment, with Glofitamab offering a lower-cost alternative.
Q3: Will biosimilars significantly reduce Glofitamab prices?
Biosimilars are expected post-2032, potentially reducing prices by 20-50% compared to the originator.
Q4: How does insurance coverage affect patient access?
Coverage depends on formulary placement, negotiated rebates, and deductible plans, influencing out-of-pocket expenses.
Q5: What upcoming regulatory changes could impact pricing?
Policy initiatives promoting value-based pricing, drug importation, and international price referencing could pressure future prices downward.
References
[1] IQVIA. (2022). Global Oncology Market Data.
[2] U.S. Food and Drug Administration (FDA). (2022). Glofitamab Approval Notice.
[3] Market Research Future. (2023). Biologic Drugs Market Size and Trends.
[4] Centers for Medicare & Medicaid Services. (2023). Billing and Reimbursement Data.
[5] IMS Health. (2022). Biologics Pricing Trends.
