The information below is intended for licensed U.S. healthcare providers
pharma& understands the importance of maintaining continuity of care to help patients stay on treatments, such as PEGASYS® (peginterferon alfa-2a), that may support them in their healthcare journey.
PEGASYS® injection remains available in the U.S. for eligible patients. We anticipate the continued availability of the 180mcg/0.5ml pre-filled syringe formulation of PEGASYS® in the U.S without significant disruptions to availability. We are actively working with the Food and Drug Administration (FDA) to ensure this method of administration remains available in the near and long term. In September 2025, access to the 180mcg/1.0ml vial formulation of PEGASYS® in the U.S. is expected to become increasingly limited before transitioning to being completely unavailable; however, the 180mcg/0.5ml pre-filled syringe formulation will remain available for eligible patients going forward.
With this in mind, we encourage healthcare providers to initiate an open dialogue with eligible patients who may be impacted by non-availability of the PEGASYS® 180mcg/1ml vial formulation to discuss their treatment plan, alternative PEGASYS® methods of administration, and appropriate dosage.
For any questions, please contact medinfo.us@pharmaand.com
The Background
In 2019, the original manufacturer, F. Hoffman-La Roche AG, announced that it would stop the commercialization of PEGASYS® globally. Understanding the importance of treatments such as PEGASYS®, pharma& acquired the global rights to PEGASYS® in 2021, with the aim of providing continuity of care for eligible patients. As part of the acquisition, pharma& obtained all the remaining PEGASYS® peginterferon alfa-2a active pharmaceutical ingredient (API) from Roche, which had produced a final batch of API in 2017 and was estimated to cover treatment for eligible patients globally for approximately 10 years.
However, the demand for PEGASYS® increased greatly since then due to a number of recent market changes. As a result, the final product batch produced in 2017 will not suffice for the intended period of 10 years. As soon as we became aware of this, pharma& promptly implemented mitigation strategies designed to optimize the availability of PEGASYS® over the coming years and to accelerate our manufacturing plans for new API production at our wholly-owned facility, Loba biotech GmbH.
In October 2024, pharma& proactively notified the U.S. FDA out of an abundance of caution and in transparency, of a potential limited supply of PEGASYS® in the U.S. from Q4 2025. Following this notification, pharma& has been actively working with the FDA to limit any potential interruptions in PEGASYS® availability in the U.S.
pharma&’s Investment in the Future Availability of PEGASYS®
Recent approvals by the European Medicines Agency (EMA) and the United Kingdom and Swiss regulatory authorities to include Loba biotech GmbH, a wholly-owned subsidiary of pharma&, as a PEGASYS® API manufacturing site underscore pharma&’s ongoing commitment to supporting continuous global supply and highlights the progress we have made in securing the long-term and reliable availability of PEGASYS®. pharma& has submitted a post-approval supplement to the FDA for a similar approval to serve the U.S. market.
Without pharma&’s investment in Loba biotech, the future availability of PEGASYS® would not have been possible. We remain committed to minimizing the impact of this transition on PEGASYS® distribution for the U.S. and to maintaining a robust and reliable supply chain that aims to provide consistent distribution of PEGASYS®, supporting the continuity of care for eligible patients.
Thank You for Your Support and Patience
We thank you for your understanding and patience during this period. pharma& will continue to monitor the availability of PEGASYS® in the U.S. and remains dedicated to ensuring your patients’ access to this medicine.
Questions and Contact Information
Again, if you have any additional questions regarding the availability of PEGASYS® in the U.S., please submit a medical information request to pharma& at medinfo.us@pharmaand.com.
Safety Information
EPAR (last updated 04/09/2024)
SmPC – Product Information (last updated 05/08/2024)
For non-EU countries please refer to your local health authority
For U.S.A. USPI (last updated 02/2024)
For Canada – As previously supplied by Hoffmann-La Roche Limited, the pre-filled syringe is the only Pegasys® format available from pharmaand GmbH and Accelera Pharma Canada Inc.
Pour le Canada – La seringue préremplie Pegasys®, fournie auparavant par Hoffmann-La Roche Limited, est l’unique présentation disponible auprès de pharmaand GmbH et Accelera Pharma Canada Inc.