Byooviz Shortage: What Providers and Prescribers Need to Know in 2026

Provider Briefing: Byooviz Availability in 2026

If your practice prescribes or administers anti-VEGF injections, you've likely encountered questions — from patients, staff, and colleagues — about the availability of Byooviz (Ranibizumab-nuna). While Byooviz is not currently on the FDA's official drug shortage list, real-world access challenges persist, and they directly affect your patients' treatment continuity.

This article provides an evidence-based overview of the current Byooviz landscape, including availability, prescribing considerations, cost and reimbursement factors, and resources to help your practice and patients navigate the situation.

Timeline: Byooviz From Approval to Now

Understanding where Byooviz fits in the anti-VEGF market requires context:

• September 2021: FDA approves Byooviz (SB11) as the first ophthalmology biosimilar in the U.S., referencing Lucentis (Ranibizumab)
• June 2022: Biogen and Samsung Bioepis launch Byooviz commercially at a list price of $1,130 per vial — a 40% discount to Lucentis ($1,850)
• August 2022: FDA approves Cimerli (Ranibizumab-eqrn), a second Lucentis biosimilar
• October 2023: FDA grants Byooviz interchangeability designation
• 2023-2025: Broader market shifts as Vabysmo (Faricimab) and Eylea HD (Aflibercept 8 mg) gain market share, compressing the Ranibizumab segment
• 2026: Byooviz availability continues to be provider-dependent; no formal FDA shortage

Prescribing Implications

Approved Indications

Byooviz is FDA-approved for three indications at the 0.5 mg dose:

1. Neovascular (wet) age-related macular degeneration (nAMD)
2. Macular edema following retinal vein occlusion (RVO)
3. Myopic choroidal neovascularization (mCNV)

Notably, Byooviz is not approved for diabetic macular edema (DME) or diabetic retinopathy (DR) — indications for which Lucentis is approved at the 0.3 mg dose. Byooviz's single-dose vial only delivers the 0.5 mg dose. This is a critical consideration for practices with a significant diabetic patient population.

Interchangeability

Since October 2023, Byooviz carries an interchangeability designation, allowing pharmacies and providers to substitute it for Lucentis without additional prescriber approval in most states. For practices using buy-and-bill, this means stocking decisions can be made at the practice level based on cost and availability.

Dosing and Administration

Byooviz is administered as a 0.5 mg (0.05 mL) intravitreal injection approximately once monthly (every 28 days). Standard aseptic intravitreal injection technique applies. The medication must be refrigerated (2°C to 8°C) and protected from light.

For detailed prescribing information, consult the full Byooviz prescribing overview.

Current Availability Picture

The current availability of Byooviz is best described as variable by practice and region. Contributing factors include:

1. Buy-and-Bill Economics

Anti-VEGF injections operate under the buy-and-bill model, where the provider purchases the drug and seeks reimbursement from the payer. Reimbursement is typically based on average sales price (ASP) + 6% under Medicare Part B. For biosimilars, the reimbursement calculation can be less favorable than for established products with higher ASPs, potentially reducing the financial incentive to stock Byooviz.

2. Declining Ranibizumab Market Share

Lucentis market share has declined substantially as Eylea, Vabysmo, and off-label Avastin dominate the anti-VEGF market. With Lucentis holding approximately 9% market share, the addressable market for Ranibizumab biosimilars is limited. Some practices have determined that stocking Ranibizumab products — including Byooviz — is not warranted given their patient mix.

3. Specialty Distribution

Byooviz is distributed through specialty channels, not traditional wholesale networks. Practices must maintain relationships with specialty distributors, and any disruption in these channels can create localized access issues.

Cost and Access Considerations

Providers should be aware of the following cost dynamics:

• Byooviz WAC: ~$1,130 per vial
• Lucentis WAC: ~$1,850 per vial
• Compounded Avastin: ~$50-$75 per dose
• Eylea (2 mg): ~$1,850 per injection
• Vabysmo: ~$2,190 per injection

Medicare Part B reimburses biosimilars at the biosimilar's ASP + 6% of the reference product's ASP. For qualified biosimilars, this may offer a slight margin advantage, but practices should verify current ASP-based reimbursement rates with their billing team.

Patient Financial Support

For commercially insured patients, the Biogen Copay Program can reduce out-of-pocket costs to as low as $0. Enrollment is available through Biogen Biosimilar Support Services at 1-877-422-8360.

For uninsured or underinsured patients, Biogen's patient assistance program may provide Byooviz at no cost. Additional resources include NeedyMeds.org and RxAssist.org.

For more detailed cost information, see our provider's guide to saving patients money on Byooviz.

Tools and Resources for Your Practice

Medfinder for Providers

Medfinder offers a provider-facing tool to help your patients locate specialty medications when your practice can't supply them. Rather than sending patients away empty-handed, you can direct them to Medfinder to find another provider with Byooviz in stock.

Biogen Biosimilar Support Services

Biogen's dedicated support team (1-877-422-8360) can assist with:

• Ordering and distribution questions
• Prior authorization support
• Patient enrollment in copay and assistance programs
• Practice onboarding for Byooviz

Alternative Anti-VEGF Options

When Byooviz is unavailable, consider these therapeutic alternatives:

• Cimerli (Ranibizumab-eqrn): Interchangeable Lucentis biosimilar, approved for all five Lucentis indications
• Eylea (Aflibercept 2 mg): Established anti-VEGF with 4-8 week dosing intervals
• Eylea HD (Aflibercept 8 mg): Extended dosing intervals up to 12-16 weeks
• Vabysmo (Faricimab): Bispecific antibody targeting VEGF-A and Ang-2, intervals up to 16 weeks
• Avastin (Bevacizumab): Off-label use, compounded, significantly lower cost

For clinical comparison details, see our article on alternatives to Byooviz.

Looking Ahead

Several developments may impact Byooviz availability and the broader anti-VEGF market in the coming years:

• Aflibercept biosimilars are progressing through the FDA approval pipeline, which could reshape anti-VEGF economics
• Medicare reimbursement policies for biosimilars continue to evolve, with potential incentives for biosimilar adoption
• Port delivery systems and sustained-release implants may reduce the need for monthly injections
• Gene therapy approaches for wet AMD are in clinical development

Staying informed about these developments will help your practice make proactive formulary and stocking decisions.

Final Thoughts

Byooviz remains a clinically effective and cost-efficient option for appropriate patients, but real-world availability challenges require proactive management. Understanding the market dynamics, maintaining relationships with specialty distributors, and leveraging tools like Medfinder and Biogen Support Services can help ensure your patients maintain uninterrupted anti-VEGF therapy.

The bottom line: treatment gaps pose a greater risk to patient outcomes than switching between anti-VEGF agents. When Byooviz isn't available, have a documented protocol for therapeutic substitution to keep patients on track.