Last updated: February 24, 2026
What is the product associated with NDC 72319-0006?
NDC 72319-0006 refers to Avastin (bevacizumab), 100 mg/vial. It is a monoclonal antibody used primarily for various cancers, including colorectal, lung, kidney, and glioblastoma. Approved by FDA since 2004, Avastin's patent expired in most regions around 2018, but biosimilars entered the market, impacting pricing and market dynamics.
What is the current market landscape?
Market size and segments
The global oncology monoclonal antibody market was valued at approximately USD 34 billion in 2022. Avastin holds a significant share, estimated at 15-20% of this segment, with annual revenues around USD 4-6 billion pre-biosimilar competition.
Key competitors and biosimilars
Since Avastin's patent expiration, multiple biosimilars have entered the market:
- Lucentis (ranibizumab) – Not a biosimilar but a competing biologic.
- Amgen’s Mvasi (bevacizumab-awwb) – Approved in 2017, priced approximately 15% lower than Avastin.
- Samsung Bioepis’(bevacizumab biosimilar) – Approved in the US in 2021, priced around 20-25% below the originator.
- Coherus’ (U.S.) BevaciGen (pending approval) – Expected to price similar to current biosimilars.
The biosimilar market has reduced Avastin's US revenue by roughly 30% since 2018.
Regulatory environment
In the US, biosimilars gain approval under the abbreviated pathway (Section 351(k) of the Public Health Service Act). The FDA has approved five biosimilars for Avastin, with additional approvals expected, further intensifying price competition.
What are the current pricing trends?
Original drug pricing
- Avastin (brand) has historically been priced at USD 5,000 - 6,000 per 400 mg vial.
- Cost per mg: Approximately USD 12.50 - 15.
Biosimilar pricing
- Entry of biosimilars has decreased prices by 20-30% relative to the originator.
- In 2022, average biosimilar prices ranged from USD 3,800 to 4,200 per 400 mg vial.
Price erosion projections
- Year 1 post-biosimilar entry: 20-25% decline.
- Year 3: Up to 40-50% cumulative decline.
- Long-term: Stabilization at 50% discount to original prices in highly competitive markets.
Reimbursement landscape
CMS and private payers increasingly favor biosimilars, which are reimbursed at similar or lower rates than the originator, incentivizing adoption and further price reductions.
How is market growth expected to evolve?
Forecasting factors
- Expansion into new indications: Approval for ophthalmology and other indications.
- Biosimilar adoption rates: Expected to reach 75-85% penetration in the US by 2025.
- Developments in pricing policies: Managed care push for biosimilar use to control costs.
- Emergence of next-generation biologics: Potential competition from novel therapies.
Revenue projections
- 2023-2025: Avastin's US revenues could decline to USD 3-4 billion annually.
- Global market: Slower decline; EM countries and emerging markets may have delayed biosimilar access, sustaining higher prices longer.
What are the implications for stakeholders?
For manufacturers
- Biosimilar companies will face aggressive price competition.
- Avastin’s innovator company must innovate or diversify pipeline.
For payers
- Greater emphasis on biosimilars reduces costs.
- Preference for biosimilars in formulary decisions.
For investors
- Biosimilar entrants offer upside but with margin compression.
- Original biologics may stabilize at lower prices but maintain significant share.
Summary table of key data
| Aspect |
Data |
| Originator (Avastin) Price |
USD 5,000 - 6,000 per 400 mg vial |
| Biosimilar Price Range |
USD 3,800 - 4,200 per 400 mg vial |
| Biosimilar Market Share |
20-25% in US as of 2022 |
| Revenue Decline Post-Biosimilar |
30% decrease since 2018 |
| Expected Price Discount |
50% reduction relative to originator in 3-5 years |
| Market Penetration by 2025 |
75-85% in US |
Key takeaways
- Biosimilar competition significantly decreased Avastin’s US revenues, with ongoing price reductions projected.
- The biosimilar market is expected to further accelerate price erosion, reaching up to 50% discounts in the next 2-5 years.
- Strategic considerations include biosimilar regulatory approvals, payer preferences, and pipeline diversification.
- Long-term market stability relies on new indications, pricing policies, and innovative therapeutics.
FAQs
What are the main biosimilars of Avastin currently approved?
Amgen’s Mvasi and Samsung Bioepis’ biosimilar are the primary approved biosimilars in the US.
Will Avastin’s price continue to decline?
Yes, biosimilar market entry and increasing adoption will drive prices downward, potentially reaching 50% below original prices within five years.
How does biosimilar market penetration impact revenues?
Market penetration of biosimilars reduces Avastin’s US revenues by approximately 30-50%, depending on doctor and payer adoption rates.
Are biosimilars interchangeable with Avastin?
Regulatory approval in the US allows biosimilars to be used interchangeably in certain settings, impacting prescribing behavior.
What factors could slow biosimilar price erosion?
Limited biosimilar supply, patent litigations, limited payer acceptance, and slow regulatory approvals in certain regions.
References:
- IQVIA. (2022). Global Oncology Market Report.
- FDA. (2022). Biosimilar approvals and guidance.
- EvaluatePharma. (2022). Biosimilar market forecasts.
- CMS. (2021). Medicare reimbursement policies for biosimilars.
- Pharmaceutical Technologies. (2023). Pricing trends for monoclonal antibodies.
