Pegasys® Is Back in Europe: EMA Approves New Manufacturing Site

May 8
2 min read

Good news for patients with Myeloproliferative Neoplasms (MPNs): Pegasys® is being replenished across Europe following a key regulatory approval.

On April 25, 2025, the European Medicines Agency (EMA) officially approved Loba biotech GmbH, a wholly owned manufacturing subsidiary of pharma& GmbH, as an authorized production site for the active pharmaceutical ingredient (API) peginterferon alfa-2a, the key component of Pegasys®.

This decision allows pharma& to resume supply of Pegasys® in EU member states, Iceland, and Norway, restoring access for eligible patients who rely on this essential treatment.

What caused the Pegasys® shortage?

In 2019, F. Hoffmann-La Roche AG (Roche), the original developer of Pegasys®, announced it would stop commercializing the medication globally. In response, pharma& acquired the global rights in 2021 to ensure continued availability. However, the increased global demand and the need to establish new manufacturing capabilities delayed production.

To secure long-term supply, pharma& invested in Loba biotech GmbH, building its own bio-manufacturing infrastructure. The recent EMA approval confirms that this facility meets the strict regulatory standards required to produce peginterferon alfa-2a.

What does this mean for patients?

Patients in Europe should begin to see improved access to Pegasys® in the coming weeks. According to pharma&, replenishment outside of Europe—such as in the United States and other regions—is a top priority, and they are actively working with regulators to make the medication available as soon as possible.

What’s next?

Patients currently prescribed Pegasys®, or those interested in learning more about treatment options for MPNs, are encouraged to speak with their healthcare providers. If you’ve been affected by the recent shortage, keep in touch with your care team to explore updated availability and next steps.

Thanks to our president, Peter Loffelhardt, for his continued commitment to informing and supporting the MPN community.

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