pharma& has announced that the European Medicines Agency (EMA) has granted a variation to the Marketing Authorisation for Pegasys (peginterferon alfa-2a), allowing Loba biotech, a wholly owned manufacturing subsidiary of pharma&, to be included as an approved site for the production of the active pharmaceutical ingredient (API), peginterferon alfa-2a.
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The approval enables pharma& to begin Pegasys product replenishment across Europe and bolsters enduring supply chain resilience. pharma& anticipates eligible European patients should start to experience improved Pegasys availability in the coming weeks.
“We are thrilled to announce the EMA’s approval for Pegasys API production at Loba biotech. This is a key milestone on the path to Pegasys replenishment across Europe today and in other regions in the near future,” said Elmar Zagler, founder and managing director, pharma&. “Since acquiring Pegasys, pharma& has been committed to ensuring this important medicine's continuous availability to eligible patients. Our investment in Loba biotech and the EMA's approval is a pivotal step in delivering on pharma&’s mission to preserve the availability and foster the further development of essential medicines worldwide to leave no patient behind.”
In 2019, F. Hoffmann La Roche AG (Roche) announced that it would cease commercialising Pegasys globally. pharma& acquired the global rights to Pegasys in 2021 from Roche, intending to ensure continuity of care for eligible patients. Following pharma&’s acquisition of Pegasys, pharma& encountered increased product demand. As a result of the growing need among eligible patients, pharma& committed to investing in bio-manufacturing capabilities at pharma&’s wholly owned manufacturing plant subsidiary, Loba biotech. This significant investment was essential for the new plant to produce the API in Pegasys.
Replenishing Pegasys outside of Europe is a top priority, and pharma&, alongside its partners, is actively collaborating with regulatory authorities to enhance availability for eligible patients in the U.S. and other regions as swiftly as possible.