Drug Shortage Report for PEGASYS

Last updated on 2024-10-30 History
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
v1 2024-10-29 English Compare
v2 2024-10-29 French Compare
v3 2024-10-29 English Compare
v4 2024-10-29 French Compare
v5 2024-10-30 English Compare
v6 2024-10-30 French Compare
v7 2024-10-30 English Compare
v8 2024-10-30 French Compare
v9 2024-10-30 English Compare
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