Drug Shortage Report for PEGASYS
| Report ID | 241524 |
| 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 | 2025-12-31 |
| Actual end date | |
| Shortage status | Actual shortage |
| Updated date | 2024-10-30 |
| 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. |
| Health Canada comments | |
| Tier 3 Status | No |
| Contact Address | TABORSTRASSE 1 1020 VIENNA, -- AUSTRIA |
| Company contact information |
Version History
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| Version Number | Date Updated | Language | |
|---|---|---|---|
| v10 | 2024-10-30 | French | Compare |
| v9 | 2024-10-30 | English | Compare |
| v8 | 2024-10-30 | French | Compare |
| v7 | 2024-10-30 | English | Compare |
| v6 | 2024-10-30 | French | Compare |
| v5 | 2024-10-30 | English | Compare |
| v4 | 2024-10-29 | French | Compare |
| v3 | 2024-10-29 | English | Compare |
| v2 | 2024-10-29 | French | Compare |
| v1 | 2024-10-29 | English | Compare |
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