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Version v10-FR Version v5-EN
Language French English
Date Updated 2024-10-30 2024-10-30
Drug Identification Number 02248077 02248077
Brand name PEGASYS PEGASYS
Common or Proper name peginterferon alfa-2A injection peginterferon alfa-2A injection
Company Name PHARMAAND GMBH PHARMAAND GMBH
Ingredients PEGINTERFERON ALFA-2A PEGINTERFERON ALFA-2A
Strength(s) 180MCG 180MCG
Dosage form(s) SOLUTION SOLUTION
Route of administration SUBCUTANEOUS SUBCUTANEOUS SUBCUTANEOUS SUBCUTANEOUS
Packaging size pre-filled syringes 180 mcg/0.5 mL pre-filled syringes 180 mcg/0.5 mL
ATC code L03AB L03AB
ATC description IMMUNOSTIMULANTS IMMUNOSTIMULANTS
Reason for shortage Disruption of the manufacture of the drug. Disruption of the manufacture of the drug.
Anticipated start date 2024-10-29 2024-10-29
Actual start date 2024-10-29 2024-10-29
Estimated end date 2025-12-31 2025-12-31
Actual end date
Shortage status Actual shortage Actual shortage
Tier 3 Status No No
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. Traduction française à venir: 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.
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