Drug Report History
Below you will find the report version history. When a report is updated, a new version of the report is created. The report history allows you to see the changes between versions. You can select two versions of the report to compare. The fields that were changed between versions will be highlighted in yellow.
The translation of reports creates two separate versions which is why some reports may not seem to have any differences. In this case, only the language field below will be highlighted in yellow.
| Version v10-FR | Version v8-FR | |
|---|---|---|
| Language | French | French |
| 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. | .Seul fabricant de l’IPA Pegasys®, Roche Diagnostics GmbH a produit un dernier lot de peginterféron alfa-2a en 2017. La constitution du nouveau fabricant d’IPA pour le peginterféron alfa-2a, Loba biotech GmbH, Fischamend, en Autriche (société affiliée de pharmaand GmbH) est toujours en cours. Avant que Roche Diagnotics GmbH ne mette définitivement hors service la ligne de production d’IPA, elle a produit un dernier lot en 2017, dont on estime qu’il couvrira la demande mondiale pendant environ 10 ans. La demande de produits Pegasys® a fortement augmenté en raison des récents changements survenus sur le marché. En conséquence, le lot de produits final produit par Roche ne durera pas la période prévue d’environ 10 ans, et pharmaand GmbH (pharma&) a cherché à accélérer le plan de fabrication. pharma& s’est engagée à investir dans le développement continu et la certification future de nos capacités de biofabrication dans notre usine de fabrication en propriété exclusive en Autriche, Loba biotech GmbH. Il s’agit d’un investissement important qui a été nécessaire pour transférer l’ingrédient pharmaceutique actif (IPA) de Pegasys® à notre nouvelle installation, qui est un traitement biologique complexe à fabriquer, nécessitant 18 étapes de purification pour assurer la plus haute qualité et la sécurité pour le patient. |
| Health Canada comments |