Drug Shortage Report for PEGASYS
| Report ID | 241511 |
| Drug Identification Number | 02248077 |
| Brand name | PEGASYS |
| Common or Proper name | peginterferon alfa-2A injection |
| Company Name | PHARMAAND GMBH |
| Market Status | MARKETED |
| Active Ingredient(s) | PEGINTERFERON ALFA-2A |
| Strength(s) | 180MCG |
| Dosage form(s) | SOLUTION |
| Route of administration | SUBCUTANEOUS SUBCUTANEOUS |
| Packaging size | pre-filled syringes 180 mcg/0.5 mL |
| ATC code | L03AB |
| ATC description | IMMUNOSTIMULANTS |
| Reason for shortage | Disruption of the manufacture of the drug. |
| Anticipated start date | 2024-10-29 |
| Actual start date | 2024-10-29 |
| Estimated end date | 2026-06-30 |
| Actual end date | |
| Shortage status | Actual shortage |
| Updated date | 2025-11-04 |
| Company comments | The sole manufacturer of Pegasys® API, Roche Diagnostics GmbH produced a final batch of peginterferon alfa-2a in 2017. Establishment of new API manufacturer for peginterferon alfa-2a, Loba biotech GmbH, Fischamend, Austria (affiliate of pharmaand GmbH) remains in progress. Before Roche Diagnotics GmbH permanently decommissioned the API production line, they produced a final batch in 2017 which was estimated to cover global demand for approximately 10 years. Pegasys® product demand has increased significantly due to recent changes in the market. As a result, the final product batch produced by Roche will not last for the intended period of approximately 10 years, and pharmaand GmbH (pharma&) has looked to expedite the manufacturing plan. pharma& committed to investing in the ongoing development and future certification of our bio-manufacturing capabilities at our wholly-owned manufacturing plant in Austria, Loba biotech GmbH.This is a significant investment and was required to transfer the active pharmaceutical ingredient (API) in Pegasys® to our new facility, which is a complex biologic treatment to manufacture, requiring 18 purification stages to ensure the highest quality and safety for the patient. Exceptional Importation of Irish labelled stock has been approved by Health Canada until such time as the new manufacturing facility has been approved. |
| Health Canada comments | |
| Tier 3 Status | Yes |
| Contact Address | TABORSTRASSE 1 1020 VIENNA, -- AUSTRIA |
| Company contact information |
Version History
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| Version Number | Date Updated | Language | |
|---|---|---|---|
| v6 | 2025-11-04 | English | Compare |
| v5 | 2025-10-10 | French | Compare |
| v4 | 2025-10-10 | English | Compare |
| v3 | 2025-10-10 | English | Compare |
| v2 | 2025-10-10 | English | Compare |
| v1 | 2024-10-29 | English | Compare |
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