Pegasys Shortage Update: What Patients Need to Know in 2026

The Pegasys (Peginterferon Alfa-2a) shortage has been one of the most disruptive drug shortages in specialty medicine in recent years. It has affected patients with chronic hepatitis B, hepatitis C, and myeloproliferative neoplasms (MPNs) like polycythemia vera and essential thrombocythemia. Here is a full update on where things stand in 2026 and what you should know to protect your treatment.

Current Status: Is Pegasys Still in Shortage?

Yes. As of early 2026, Pegasys remains in an active FDA-confirmed drug shortage. Both the 180 mcg/mL vials and 180 mcg/0.5 mL prefilled syringes are affected. Supply through specialty distributor Summit SD is limited and allocated, meaning pharmacies can only order a restricted amount at a time. Patients who have been on Pegasys for years have reported missed doses, treatment delays, and significant anxiety about their disease management.

Timeline: How the Shortage Developed

Understanding how the shortage developed helps explain why it has been so difficult to resolve:

• 2021: Roche sold worldwide rights to Pegasys (outside China and Japan) to zr pharma& GmbH, a European specialty pharma company.
• 2023–2024: Manufacturing site transitions began; demand from off-label MPN use began to surge.
• August 2024: European Commission approved Pegasys for MPN indications in Europe, further increasing global demand.
• October 2024: pharma& notified the US FDA of potential supply constraints as demand outpaced production capacity.
• Late 2024: ASHP officially listed peginterferon alfa-2a as being in shortage. Supply through Summit SD became severely limited.
• April 2025: EMA approved pharma&'s new API manufacturing site at Loba biotech GmbH for European supply.
• Early 2026: US FDA approval of the new manufacturing site remains pending. Shortage is ongoing.

Which Formulations Are Affected?

The shortage affects both main formulations:

• Pegasys 180 mcg/mL single-use vials
• Pegasys 180 mcg/0.5 mL prefilled syringes (Pegasys Prefilled Syringe)
• Pegasys ProClick 180 mcg/0.5 mL autoinjectors

What Is Being Done to Resolve the Shortage?

pharma& GmbH is investing in new manufacturing capacity at Loba biotech GmbH. The EMA approved this new site in April 2025 for European supply, but the US FDA has not yet approved it for US supply. Once FDA approval is granted, the new facility should be able to meaningfully increase US supply. There is no publicly confirmed timeline for this approval, though it is the most important pending development.

How Is the Shortage Affecting Different Patient Groups?

The impact varies significantly by condition:

• Polycythemia vera / MPN patients: Most severely affected. These patients often have no other FDA-approved interferon option (though BESREMi is available for PV). Treatment interruptions can cause disease progression and blood count deterioration.
• Hepatitis C patients: For most patients, highly effective oral DAA alternatives exist. The shortage is pushing many remaining interferon-based HCV patients toward DAA therapy, which most guidelines already recommend as first-line.
• Hepatitis B patients: Can typically transition to oral antivirals (entecavir, tenofovir) for viral suppression, though this usually requires indefinite treatment vs. the finite course Pegasys offers.

What Patients Can Do Right Now

Here are the most effective steps patients can take during the shortage:

1. Search for available pharmacies using medfinder — call pharmacies in your area and receive results by text.
2. Contact pharma& patient line: 855-443-7028 for help finding supply or patient assistance.
3. Ask your doctor about alternatives: BESREMi for PV, DAAs for hepatitis C, oral antivirals for hepatitis B.
4. Start refill searches early: Begin 2–3 weeks before your next dose is due.
5. Try independent specialty pharmacies: These sometimes have access to different distributor channels than chain pharmacies.

Bottom Line for Patients

The Pegasys shortage is serious, ongoing, and unlikely to resolve immediately. The most important things you can do are start your refill process early, use available tools to search for stock, talk to your doctor about alternatives, and advocate for yourself with pharmacies and your care team. For a full breakdown of your alternatives, see our guide on alternatives to Pegasys when you can't fill your prescription.