Last updated: September 2, 2026
Bevacizumab-awwb, marketed by Amgen as Mvasi, was the first FDA-approved biosimilar to Avastin (bevacizumab). It entered the U.S. market in July 2019 and established a large commercial position in oncology biosimilars. Its financial trajectory has shifted from rapid uptake and price-led substitution to a mature, increasingly competitive market as Pfizer’s Zirabev, Viatris and Biocon’s Alymsys, Celltrion’s Vegzelma, and other bevacizumab biosimilars expanded the field.
Amgen continues to report Mvasi as a separate product, but does not disclose product-level operating profit, prescription volume, average selling price, or net price by payer. Public filings support a conclusion that Mvasi became a roughly billion-dollar annual product during its early U.S. commercialization, followed by slower growth and pricing pressure as competing biosimilars gained access and providers increased use of lower-cost alternatives (Amgen, 2020-2024).
What is bevacizumab-awwb and how is it used?
Bevacizumab-awwb is a recombinant monoclonal antibody biosimilar to bevacizumab, the active ingredient in Avastin. It binds vascular endothelial growth factor A and inhibits angiogenesis.
The FDA approved Mvasi for the same principal oncology indications as Avastin, including:
- Metastatic colorectal cancer.
- Metastatic breast cancer under the historical Avastin indication framework, although the U.S. breast-cancer indication was withdrawn.
- Non-small cell lung cancer.
- Glioblastoma.
- Metastatic renal cell carcinoma.
- Persistent, recurrent, or metastatic cervical cancer.
- Ovarian, fallopian tube, or primary peritoneal cancer under specified treatment regimens.
The product is administered intravenously. It is supplied in single-dose vials and is used in combination with chemotherapy or other oncology agents. Unlike a small-molecule generic, Mvasi is not chemically identical to Avastin. It was approved through the FDA biosimilar pathway based on analytical, pharmacokinetic, clinical, and immunogenicity evidence demonstrating biosimilarity.
Key FDA milestones
| Milestone |
Date |
| FDA approval of Mvasi |
July 28, 2017 |
| First U.S. biosimilar approval for bevacizumab |
July 28, 2017 |
| U.S. commercial launch |
July 2019 |
| Reference product |
Avastin, Genentech/Roche |
| Active ingredient |
Bevacizumab-awwb |
| Dosage form |
Intravenous infusion |
| FDA interchangeability designation |
No |
| Regulatory pathway |
351(k) biosimilar application |
The FDA approved Mvasi as biosimilar to Avastin, but it did not receive an interchangeable designation. That distinction affects automatic substitution rules at the pharmacy level. In practice, Mvasi is administered in physician offices and hospital outpatient departments, where substitution decisions are usually controlled by institutional formularies, payer policies, and oncology protocols rather than retail pharmacy substitution.
How large is the bevacizumab-awwb market?
Mvasi competes in a large but price-sensitive oncology biologics market. Avastin had already accumulated extensive use across colorectal, lung, ovarian, cervical, renal, and central nervous system cancers before biosimilar entry. That installed clinical base reduced the commercial burden of educating physicians about the mechanism and treatment setting.
The market has three principal segments:
- Reference Avastin, generally retaining use where physicians, contracts, or payer policies favor the originator.
- Mvasi, supported by Amgen’s scale, manufacturing infrastructure, and oncology sales force.
- Competing bevacizumab biosimilars, which compete primarily on price, supply reliability, contracting, and institutional access.
In provider-administered oncology, the net price is determined by commercial rebates, Medicare reimbursement, acquisition arrangements, group purchasing organization contracts, and buy-and-bill economics. List-price comparisons therefore do not fully measure market share or profitability.
Competitive bevacizumab products in the United States
| Product |
Sponsor |
FDA biosimilar approval |
Commercial position |
| Avastin |
Genentech/Roche |
Reference product |
Originator |
| Mvasi, bevacizumab-awwb |
Amgen |
July 2017 |
First entrant; established oncology infrastructure |
| Zirabev, bevacizumab-bvzr |
Pfizer |
June 2019 |
Major multinational competitor |
| Alymsys, bevacizumab-maly |
mAbxience/Viatris |
April 2022 |
Additional price competitor |
| Vegzelma, bevacizumab-adcd |
Celltrion |
September 2022 |
Celltrion oncology biosimilar platform |
| Avzvi, bevacizumab-tnjn |
Bio-Thera/Amgen |
FDA approval announced in 2024 |
Later entrant with additional competitive pressure |
FDA approval and commercial launch dates can differ because of patent settlements, manufacturing readiness, payer contracting, and inventory planning. The number of approved products does not translate directly into equal market share.
What is the financial trajectory of Mvasi?
Mvasi’s financial trajectory has four stages: prelaunch investment, rapid post-launch expansion, mature high-volume sales, and price erosion from multi-product competition.
Financial development
| Period |
Market condition |
Financial effect |
| 2017-2019 |
FDA approval, litigation resolution, launch preparation |
Development and launch costs; no full commercial contribution |
| 2019-2021 |
Early biosimilar adoption and limited competition |
Rapid revenue growth |
| 2021-2023 |
Broader payer acceptance and increasing institutional adoption |
High absolute sales, but slower growth |
| 2023 onward |
Multiple competing bevacizumab biosimilars |
Greater rebate pressure, lower net prices, and share risk |
Amgen’s public filings indicate that Mvasi reached approximately billion-dollar annual sales during the early commercial period. Exact annual sales vary by reporting period and are affected by foreign exchange, gross-to-net adjustments, and geographic reporting. Amgen reports product sales but does not publish Mvasi-specific contribution margin or U.S. average selling price (Amgen, 2020-2024).
The financial profile is different from a traditional branded oncology product. Mvasi does not require the same level of clinical differentiation as a novel therapy, but it also has less pricing power. Revenue depends on volume retention, contracting, supply availability, and the ability to defend share against products with similar clinical profiles.
Main financial drivers
Mvasi revenue is driven by:
- The volume of Avastin-treated patients converted to biosimilars.
- Share retained against Zirabev and later entrants.
- Average sales price after rebates and institutional discounts.
- Medicare and commercial payer reimbursement.
- Availability of multiple vial sizes and inventory reliability.
- Physician and hospital confidence in the product.
- Amgen’s ability to bundle Mvasi with other oncology products.
- Expansion or contraction of Avastin-treated indications.
Price erosion is likely to be gradual rather than equivalent to the immediate erosion seen after small-molecule generic entry. Provider-administered biologics require manufacturing capacity, cold-chain distribution, formulary review, and clinical workflow changes. Those barriers support a more controlled decline in net price, although competitive contracting can accelerate erosion among large hospital systems.
How does Mvasi compare with Avastin and competing biosimilars?
Mvasi’s principal commercial advantage was timing. It was the first FDA-approved bevacizumab biosimilar and benefited from Amgen’s established U.S. oncology organization. Its main disadvantages are the absence of interchangeability designation and the arrival of multiple products with similar regulatory status.
| Factor |
Mvasi |
Avastin |
Zirabev |
Alymsys/Vegzelma |
| Regulatory status |
Biosimilar |
Reference biologic |
Biosimilar |
Biosimilars |
| FDA interchangeability |
No |
Not applicable |
No |
No |
| Market entry |
2019 U.S. launch |
Original product |
2019 U.S. launch |
2022 U.S. approvals |
| Commercial strength |
Amgen scale and first-mover position |
Brand familiarity and historical use |
Pfizer scale and contracting |
Price competition and additional supply |
| Pricing outlook |
Declining under competition |
Highest price exposure |
Competitive |
Aggressive contracting potential |
| Substitution model |
Institution and payer driven |
Physician preference and contracts |
Institution and payer driven |
Institution and payer driven |
Avastin retains value in accounts that prioritize originator continuity, but its pricing position weakens as hospitals establish biosimilar protocols. Mvasi has a stronger position than later entrants in accounts where Amgen secured early contracts. The competitive advantage is less durable where hospitals use multi-source tenders or rotate products based on net price.
What patents protect bevacizumab-awwb and Avastin?
Mvasi itself is a biosimilar and generally does not depend on a new composition-of-matter patent estate equivalent to a novel drug. Its commercial protection came primarily from regulatory exclusivity, reference-product patent litigation, settlement timing, manufacturing know-how, and commercial execution.
Avastin’s historic patent estate included antibody and therapeutic-use claims held by Genentech and related Roche entities. Key U.S. patent families included patents covering anti-VEGF antibodies and their use in cancer treatment. The most important practical barrier to Mvasi was not a single long-lived patent on bevacizumab-awwb. It was the combination of reference-product patents, the Biologics Price Competition and Innovation Act litigation process, and negotiated launch timing.
Orange Book and Purple Book status
Avastin and Mvasi are biologics. The FDA Orange Book primarily lists approved small-molecule drug products and associated patents. Biologics are tracked through the FDA Purple Book and related FDA regulatory databases rather than through the standard Orange Book patent-listing framework.
The result is commercially important:
- Mvasi is not protected through an Orange Book-listed patent set in the same manner as a tablet or capsule.
- Patent disputes are handled under the BPCIA framework and conventional patent litigation.
- Biosimilar applicants assess reference-product patents, manufacturing patents, formulation patents, and method-of-use patents.
- Patent settlements can determine launch dates even when a product has already received FDA approval.
When did bevacizumab-awwb lose exclusivity?
Mvasi did not have the 12-year reference-product exclusivity period available to the original biologic because it was approved as a biosimilar. The FDA granted Mvasi regulatory approval in 2017, but commercial entry was delayed until July 2019 by patent and settlement considerations.
The relevant exclusivity timeline is:
| Event |
Date or period |
| Avastin FDA approval |
2004 |
| First biosimilar approval for bevacizumab |
2017 |
| Mvasi U.S. launch |
July 2019 |
| Second major U.S. bevacizumab biosimilar entrant |
2019 |
| Additional U.S. competitors |
2022 onward |
| Broad multi-source competition |
Established by 2022-2024 |
Mvasi did not experience a single exclusivity cliff. Its commercial exclusivity was de facto and temporary, based on first-mover status, contracting, and limited early competition. That protection weakened materially after Zirabev and later products entered the market.
Which companies challenged Avastin and Mvasi?
The main competitive challengers are Pfizer, Viatris, mAbxience, Celltrion, and other biosimilar developers. Their products challenge the reference product and compete directly with Mvasi.
The relevant distinction is between a Paragraph IV challenge and a biosimilar patent challenge:
- Paragraph IV certifications apply to abbreviated new drug applications for small-molecule generics under the Hatch-Waxman Act.
- Biosimilar applicants use the BPCIA patent-exchange process, commonly called the patent dance.
- Mvasi and competing bevacizumab biosimilars are not conventional Paragraph IV products.
Patent disputes involving Avastin biosimilars have generally centered on whether reference-product patents cover the proposed product, its manufacturing process, or its intended uses. Settlement agreements can provide a negotiated launch date without producing a trial judgment invalidating every asserted patent.
What manufacturing and intellectual-property barriers affect Mvasi?
The principal barriers are biological manufacturing and commercial execution rather than a single blocking patent.
Manufacturing barriers
Bevacizumab-awwb requires:
- Mammalian-cell production.
- High-quality monoclonal antibody purification.
- Control of glycosylation and other critical quality attributes.
- Sterile fill-finish operations.
- Cold-chain distribution.
- Consistent supply of single-dose vials.
- FDA compliance across multiple manufacturing sites.
Manufacturing scale matters because oncology providers penalize supply interruptions. A product with a lower contract price can lose share if hospitals cannot obtain reliable inventory.
Intellectual-property barriers
Relevant patent categories include:
- Anti-VEGF antibody composition claims.
- Cell-line and expression-system claims.
- Purification and manufacturing-process claims.
- Formulation and stability claims.
- Specific oncology treatment methods.
- Device or vial-related claims.
Method-of-use patents can remain commercially relevant even after core composition patents expire. Their impact is reduced when biosimilar labeling mirrors the reference product and when patent settlements permit launch for some indications while restricting others.
What is the FDA regulatory status of bevacizumab-awwb?
Mvasi remains FDA-approved as a biosimilar to Avastin for the approved indications reflected in its labeling. It is not designated interchangeable. The product must meet ongoing postmarketing pharmacovigilance, manufacturing, sterility, and quality requirements.
Biosimilar approval does not mean that all clinical risks disappear. The FDA continues to monitor immunogenicity, infusion reactions, hypertension, proteinuria, hemorrhage, gastrointestinal perforation, wound-healing complications, and other known bevacizumab-associated risks.
The regulatory risk for Mvasi is therefore more likely to arise from manufacturing observations, supply interruptions, labeling changes, or safety surveillance than from loss of approval because of ordinary competitive entry.
What generic and biosimilar launch risks exist?
The principal launch risks are commercial rather than regulatory.
Downside scenarios
- Hospital systems adopt a single preferred bevacizumab biosimilar and exclude Mvasi.
- Pfizer or another competitor offers deeper rebates tied to a broader oncology portfolio.
- Amgen loses share when accounts move from first-mover contracts to multi-source tenders.
- Net price declines faster than patient volume increases.
- Supply disruptions cause oncologists to standardize on another product.
- Payer policies favor a lower-cost biosimilar without automatic substitution.
- Avastin use declines because oncology regimens shift to newer targeted or immuno-oncology treatments.
Supportive scenarios
- Biosimilar conversion expands the total number of bevacizumab-treated patients.
- Amgen maintains preferred status in large oncology networks.
- Mvasi benefits from reliable supply and broad vial availability.
- New indications or treatment combinations expand the underlying bevacizumab market.
- Hospitals retain multiple suppliers to reduce shortage risk.
How strong is the Mvasi patent estate?
Mvasi has a moderate commercial protection profile but a limited standalone patent moat. The product’s strength comes from Amgen’s manufacturing capabilities, regulatory compliance, customer access, and contracting scale.
| Protection factor |
Assessment |
| New composition patent on Mvasi |
Limited |
| Reference-product patent barrier |
Largely addressed through launch settlement and expiry dynamics |
| Regulatory exclusivity |
Biosimilar approval does not create reference-product exclusivity |
| Manufacturing know-how |
Meaningful |
| Distribution and supply reliability |
Meaningful |
| Physician and hospital contracts |
Important but renewable |
| Interchangeability advantage |
Not available |
| Long-term pricing power |
Limited |
The estate is stronger as a commercial platform than as a traditional patent-protected asset. Investors should assess Mvasi through share retention, net pricing, contract duration, and manufacturing reliability rather than patent expiration alone.
What geographic markets are most important?
The United States is the key profit market because oncology biologics command higher prices and Amgen has a large commercial infrastructure. Europe has earlier and broader biosimilar adoption, but prices are often shaped by national tenders and centralized procurement. That produces faster substitution and lower net prices.
Important geographic considerations include:
- U.S. buy-and-bill reimbursement and provider economics.
- European hospital tenders.
- National reimbursement decisions in Canada, Japan, and Australia.
- Local manufacturing and import requirements.
- Reference-product brand loyalty.
- Varying rules for biosimilar substitution.
- Currency effects in Amgen’s international reporting.
Mvasi’s first-mover advantage is most valuable in markets where provider choice, formulary access, and contracting are fragmented. In centralized tender markets, price and supply often dominate brand history.
What licensing deals and partnerships affect bevacizumab-awwb?
Amgen’s principal advantage is internal scale and its broader biosimilar portfolio. Mvasi was developed and commercialized by Amgen rather than relying on a widely publicized external licensing model comparable to certain partnered biosimilar programs.
The commercial model is based on:
- Amgen’s biologics development capabilities.
- Internal manufacturing and quality systems.
- Established oncology sales channels.
- Payer and hospital contracting.
- Portfolio-level relationships with health systems.
For competitor products, partnerships between regional developers and multinational companies are common. These arrangements can combine a developer’s biosimilar molecule with a partner’s regulatory, manufacturing, or commercial infrastructure. Such partnerships increase the number of credible competitors without requiring each developer to build a complete global sales organization.
What litigation and settlement issues affect Mvasi?
The main litigation risk was concentrated before and around launch. Biosimilar sponsors typically evaluate reference-product patents before filing, exchange patent information under the BPCIA, and negotiate launch timing or litigate selected claims.
For Mvasi, the commercial outcome was a permitted U.S. launch in July 2019. That launch timing reduced the risk of prolonged uncertainty and allowed Amgen to build share before the market became crowded.
Future litigation risk is more likely to involve:
- Manufacturing patents.
- Labeling and carve-out disputes.
- Formulation claims.
- Patent enforcement against later entrants.
- Contracting practices and biosimilar substitution.
- Product liability and pharmacovigilance matters.
Key Takeaways
- Bevacizumab-awwb is Amgen’s Mvasi, the first FDA-approved bevacizumab biosimilar.
- Mvasi launched in the United States in July 2019 after patent-related launch constraints were resolved.
- Amgen built Mvasi into a roughly billion-dollar annual product during its early commercial years.
- Revenue growth is now constrained by Zirabev and additional bevacizumab biosimilars.
- Mvasi has no interchangeable designation, so hospital formularies, payer policies, and contracting drive substitution.
- The product is not protected by a conventional Orange Book patent estate.
- Its strongest protections are manufacturing scale, supply reliability, oncology distribution, and institutional contracts.
- The main financial risk is sustained net-price erosion combined with share loss.
- The main market opportunity is continued conversion from Avastin to lower-cost biosimilars and expansion of biosimilar use across oncology settings.
- Mvasi’s long-term value depends more on volume retention and cost control than on patent life.
FAQs About Bevacizumab-Awwb
Is bevacizumab-awwb the same as Avastin?
Bevacizumab-awwb is highly similar to Avastin and has no clinically meaningful differences in safety, purity, or potency under the FDA biosimilar standard. It is not chemically identical in the manner of a small-molecule generic.
Can a pharmacy automatically substitute Mvasi for Avastin?
No. Mvasi does not have an FDA interchangeability designation. Substitution is generally controlled by the treating institution, physician, payer, or oncology protocol.
Does Mvasi have a Paragraph IV patent challenge?
No conventional Paragraph IV framework applies because Mvasi is a biologic biosimilar rather than a Hatch-Waxman small-molecule generic. Its patent process followed the BPCIA framework.
Why can Mvasi sales decline even if biosimilar use increases?
Mvasi sales can decline if total bevacizumab volume grows while Mvasi loses share to Zirabev or other biosimilars, or if rebates and hospital discounts reduce the net price faster than volume expands.
Is Mvasi exposed to biosimilar competition outside the United States?
Yes. European and other international markets have multiple bevacizumab biosimilars, and centralized tenders can produce faster switching and lower net prices than the U.S. market.
References
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Amgen Inc. (2020). 2020 annual report. Amgen Inc.
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Amgen Inc. (2021). 2021 annual report. Amgen Inc.
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Amgen Inc. (2022). 2022 annual report. Amgen Inc.
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Amgen Inc. (2023). 2023 annual report. Amgen Inc.
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Amgen Inc. (2024). 2024 annual report. Amgen Inc.
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U.S. Food and Drug Administration. (2017, July 28). FDA approves first biosimilar for the treatment of cancer. https://www.fda.gov
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