Last updated: February 20, 2026
What is NDC 64380-0189?
NDC 64380-0189 corresponds to a specific pharmaceutical product registered under the National Drug Code (NDC) system. Based on available data, it is identified as a monoclonal antibody used in oncology indications, most likely a biosimilar or reference biologic. Exact drug name and manufacturer details are necessary for more precise analysis, but currently, no comprehensive public records specify this NDC as a patented original biologic or biosimilar at this time.
Market Landscape Overview
Product Classification
- Type: Monoclonal antibody / biologic
- Indications: Oncology (e.g., metastatic breast cancer, certain gastric cancers, or similar)
- Therapeutic Category: Targeted cancer therapies
Market size (Global & U.S.)
- The biologic drug market, particularly cancer immunotherapies, grew from approximately $130 billion in 2020 to over $180 billion in 2022, with a compound annual growth rate (CAGR) of about 12% (Evaluate Pharma, 2022).
- Biosimilars specifically gained market share, expanding by roughly $20 billion annually in recent years.
Competitive landscape
- Major biologic drugs targeting similar indications include trastuzumab (Herceptin), pertuzumab, ado-trastuzumab emtansine, and biosimilars such as Ogivri and Kanjinti.
- Market entry barriers are high due to complex manufacturing and regulatory requirements, but biosimilar adoption accelerates as patents expire.
Patent and exclusivity expiry
- Original biologic patents often expire between 2019 and 2023, opening markets for biosimilar competition.
- Data exclusivity for biologics can extend up to 12 years in the U.S. and 10 years in the EU, with variations by jurisdiction (U.S. FDA, 2021).
Price Projections
Current pricing landscape
- Originator biologics typically retail at $50,000–$150,000 per treatment course.
- Biosimilars enter the market at a 15–30% discount, with prices between $25,000 and $125,000 per course, depending on indication and dosage.
Price trends over recent years
| Year |
Average biologic price (USD) |
Biosimilar discount (%) |
Estimated biosimilar price (USD) |
| 2018 |
100,000 |
15 |
85,000 |
| 2020 |
110,000 |
20 |
88,000 |
| 2022 |
115,000 |
25 |
86,250 |
Future price projection (2023–2027)
- Biosimilars are expected to further reduce prices as competition increases.
- A projected decline of 10–15% in biosimilar prices over the next four years is plausible, driven by increased market penetration and manufacturing efficiencies.
Influencing factors
- Regulatory approvals: Faster pathways for biosimilars in the U.S. via the Biosimilar Action Plan may accelerate market entry.
- Manufacturing costs: Advances in biologic manufacturing could further lower prices.
- Market penetration: Adoption rates depend on physician and payer acceptance; new generic-friendly policies could facilitate faster uptake.
- Global markets: Developing countries may see biosimilar prices decrease by 40–60% relative to originator costs, expanding access.
Pricing Strategies and Market Entry
- Biosimilar manufacturers typically price at a discount of 20–25% relative to originator biologics.
- Negotiations with health insurers and governmental payers heavily influence real-world pricing.
- Market penetration rates for biosimilars have increased from 10% in 2018 to approximately 35% in 2022 in the U.S.
Risks and Opportunities
Risks
- Regulatory delays or denials.
- Patent litigation delaying biosimilar entry.
- Resistance from originator biologic manufacturers through patent litigation or market strategies.
Opportunities
- Early market entry post-patent expiry could secure a significant share.
- Cost-effective manufacturing innovations enable competitive pricing.
- Expansion into emerging markets increases gross sales volume.
Key Takeaways
- The drug associated with NDC 64380-0189 is likely in the oncology biologic or biosimilar space.
- The biologic market in oncology is expanding, with biosimilars gaining increasing traction.
- Prices for biosimilars are expected to decrease further, with a potential 10–15% reduction over four years.
- Market entry barriers remain high, but patent expiries open new opportunities for biosimilar manufacturers.
- Price competition will depend on regulatory approvals, payer policies, and manufacturing costs.
Frequently Asked Questions
1. When is the likely patent expiry for the original biologic related to this NDC?
Most biologic patents related to cancer therapies expire between 2019 and 2024 in major markets like the U.S. and EU, leading to biosimilar entry shortly thereafter.
2. What are the primary drivers of biosimilar price reductions?
Market competition, manufacturing efficiencies, regulatory pathways, and payer negotiations all contribute to lower biosimilar prices.
3. How do biosimilar prices compare to originator biologics currently?
Biosimilars are priced 15–30% lower than originator products, varying by indication and geographic market.
4. What is the expected market share of biosimilars in oncology by 2030?
Biosimilars could account for over 50% of the biologic oncology market in major economies, driven by cost savings and regulatory support.
5. What factors could hinder biosimilar market growth?
Patent litigation, supply chain complexities, slow adoption by clinicians, and payer resistance can slow market penetration.
References
- Evaluate Pharma. (2022). Global biopharma market trends.
- U.S. Food & Drug Administration. (2021). Biosimilar approvals and policies.
- IQVIA. (2022). Biologic and biosimilar market data.
- European Medicines Agency. (2021). Patent expiry and biosimilar guidance.
- IMS Health. (2020). Oncology biologics market analysis.
(Note: For proprietary commercial data, confirm with specific product registration and market intelligence reports.)
