Avastin biosimilars: FDA status, interchangeability, payer coverage, and switching

Avastin (bevacizumab, Genentech/Roche) was the first anti-angiogenic therapy approved by the FDA and has been a cornerstone of oncology treatment since 2004. US biosimilar entry began in 2019 with Amgen's Mvasi, and six biosimilars are now FDA-approved. Biosimilars have captured 92% of the bevacizumab market by volume as of Q3 2025, and average sales prices continue to decline.

This reference-product dossier is for oncology prescribers, access teams, pharmacists, and payer professionals who need to track which biosimilars are available, how payers are covering them, and what switching rules apply.

FDA-approved biosimilars

As of May 2026, six biosimilars referencing Avastin have been approved by the FDA:

Interchangeability

None of the six bevacizumab biosimilars carry the FDA interchangeable designation. All are approved as biosimilars, meaning they must be dispensed when a prescription is written specifically for the biosimilar product or when a prescriber authorizes substitution. Pharmacy-level auto-substitution is not permitted for any bevacizumab biosimilar.

Indications

Avastin is approved for a broad range of oncology indications. Not all biosimilars carry every indication, due to orphan drug exclusivity or regulatory timing:

Mvasi is not currently indicated for hepatocellular carcinoma, where Avastin holds orphan drug status. No biosimilar is indicated for the adjuvant treatment of colon cancer.

HCPCS coding

Bevacizumab products are billed under the medical benefit using specific HCPCS codes:

Separate billing codes enable payers to track utilization by product and apply product-specific reimbursement rates.

Payer and PBM coverage

Commercial insurance

Bevacizumab is administered intravenously in clinic, so it is typically covered under the medical benefit. Payer coverage is driven by:

• Formulary preferred products: Most commercial payers and PBMs designate Mvasi and Zirabev as preferred bevacizumab products. These earlier-to-market biosimilars have established lower ASPs and broader payer contracts.

• Step-through requirements: Many payers require use of a preferred biosimilar before approving the reference product or a non-preferred biosimilar. For example, Mississippi Medicaid requires trial of Mvasi or Zirabev before approving Alymsys, Vegzelma, or Avastin.

• Prior authorization: Oncology use of bevacizumab (any product) typically requires prior authorization confirming diagnosis and treatment regimen. The authorization criteria are generally the same across the reference and biosimilar products.

• Buy-and-bill reimbursement: Hospitals and clinics purchase the product and bill for administration. Reimbursement is based on ASP plus a percentage markup. Lower-cost biosimilars provide higher margins for the buy-and-bill provider.

Medicare Part B

Bevacizumab is covered under Medicare Part B (physician-administered drugs). Key considerations:

• CMS reimburses at 106% of ASP for biosimilars, which creates a financial incentive for providers to use lower-cost biosimilars because the 6% add-on yields a higher absolute margin on the reference product's higher ASP.

• The Inflation Reduction Act's Medicare Drug Price Negotiation program does not currently include bevacizumab, but biosimilar price erosion continues to reduce Part B spending on this molecule.

• A 2025 PMC study found that bevacizumab ASP declined 25.6% within three years of biosimilar entry, and the mean biosimilar ASP was 60.2% below the reference product's counterfactual price.

Hospital formulary considerations

Hospital and health system formularies have broadly adopted bevacizumab biosimilars. Mvasi and Zirabev together account for approximately 59% of bevacizumab volume. Formulary selection is influenced by:

• Group purchasing organization (GPO) contracts

• 340B pricing differentials

• Administrative convenience (single-code billing vs. product-specific codes)

• Clinical pathway committee preferences

Pricing landscape

Average sales prices (Q1 2026)

According to Samsung Bioepis's Q1 2026 Biosimilar Market Report, bevacizumab pricing (per 400 mg) as of Q1 2026:

The average ASP across all biosimilars was $986 per 400 mg in Q1 2026, a 10% decline from the prior quarter. Mvasi holds 51% volume market share, followed by Zirabev, Alymsys, and Vegzelma each at approximately 8%. Earlier-to-market biosimilars with lower established ASPs (Mvasi and Zirabev) together account for approximately 59% of bevacizumab volume.

Price erosion trend

The bevacizumab market has experienced significant price erosion since biosimilar entry:

• Q4 2024: Average biosimilar ASP was $1,093 (-7% QoQ)

• Q4 2025: Average biosimilar ASP was $1,093 (flat)

• Q1 2026: Average biosimilar ASP was $986 (-10% QoQ)

The decline in Q1 2026 was driven by discounts from newer-to-market products Alymsys and Vegzelma. Earlier-to-market products with lower established ASPs (Mvasi, Zirabev) continue to hold the majority of market share.

Commercial payment variation

A Drug Channels analysis of August 2024 negotiated commercial rates at 26 non-profit cancer hospitals showed significant payer-level variation:

• Average commercial payment for Avastin ranged from $3,007 (Aetna) to $3,542 (Anthem)

• Average payment for Mvasi ranged from $1,536 (Anthem) to $3,007 (Aetna)

• Average payment for Zirabev ranged from $1,275 (Cigna) to $1,932 (Aetna)

These figures exclude manufacturer rebates, which further reduce net cost for payers.

Market dynamics

Volume share

As of Q3 2025, biosimilars held 92% of the bevacizumab market by volume, unchanged from the prior quarter. The reference product (Avastin) retains approximately 8% volume share, reflecting some remaining contracts and 340B program dynamics in certain hospital systems.

Global context

The bevacizumab biosimilars market was valued at $1.64 billion in 2025 and is projected to reach $1.77 billion in 2026 (7.5% CAGR), growing to $2.42 billion by 2030. Approximately 15 bevacizumab biosimilars have been in development globally.

Switching and operational guidance

Medical benefit administration

Bevacizumab is administered by intravenous infusion in oncology clinics, infusion centers, and hospitals. Switching from Avastin to a biosimilar requires:

1. Prescriber writes a new order for the preferred biosimilar product.

2. Pharmacy verifies payer preference and prior authorization status.

3. Clinic purchases the preferred product through its GPO or wholesale channel.

4. Administration proceeds under the same dosing and schedule as the reference product (dosing is identical for all biosimilars).

Patient communication

Because bevacizumab is administered in clinic (not self-injected), patients may not be aware of which product they receive. Key communication points:

• The biosimilar has been FDA-approved as highly similar to Avastin with no clinically meaningful differences.

• The dosing schedule and administration process remain the same.

• The clinic has selected the product based on efficacy, safety, and cost considerations.

What to monitor

1. Jobevne launch timing: Samsung Bioepis's Jobevne (bevacizumab-nwgd) was approved in April 2025 but has not yet launched. Its market entry will further pressure pricing.

2. Interchangeability applications: No bevacizumab biosimilar currently holds interchangeable status. Monitor FDA Purple Book for any new designations.

3. Hepatocellular carcinoma indication: Avastin's orphan exclusivity for HCC may expire, potentially opening this indication to biosimilars.

4. ASP compression: Continued price erosion may benefit payers and patients but compress margins for manufacturers and providers. Monitor quarterly Samsung Bioepis market reports.

5. New entrants: Additional bevacizumab biosimilars remain in development globally. Monitor FDA filings for new applications.

Sources

• FDA. Biosimilar Product Information. Updated May 2026. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information

• FDA. Purple Book: Database of Licensed Biological Products. https://purplebooksearch.fda.gov/

• Samsung Bioepis. Biosimilar Market Report Q1 2026. February 2026. https://m.samsungbioepis.com/upload/attach/SB+Biosimilar+Market+Report+Q1+2026.pdf

• Samsung Bioepis. Biosimilar Market Report Q4 2025. January 2026. https://biologicshq.com/wp-content/uploads/2026/01/SB-Biosimilar-Market-Report-Q4-2025.pdf

• Celltrion. Vegzelma (bevacizumab-adcd) Prescribing Information. September 2022.

• Amgen. Mvasi (bevacizumab-awwb) Prescribing Information. https://www.mvasi.com/

• Drug Channels. Transparency Shocker: Biosimilars Are Getting Cheaper—But Hospitals and Insurers Can Make Them Expensive. November 2024.

• HHS ASPE. U.S. Biosimilar Market Entry Challenges and Facilitating Factors. August 2025. https://aspe.hhs.gov/sites/default/files/documents/2d5c0a194c180b52d1c760d3bb09f70a/Biosimilars%20Final%20Report_250825_v508.pdf

• Research and Markets. Bevacizumab Biosimilars Market Size and Forecast to 2030. February 2026.

• PMC. Biologic Drug Prices in Medicare Part B After Entry of Biosimilars to the Market. 2026. https://pmc.ncbi.nlm.nih.gov/articles/PMC12606378/

• Big Molecule Watch. Celltrion's Bevacizumab Biosimilar Approved by FDA. September 2022.

• Gabionline. Biosimilars of bevacizumab. https://www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab