pharma& has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a variation to the Marketing Authorisation for Pegasys (peginterferon alfa-2a), enabling Loba biotech, a wholly owned manufacturing subsidiary of pharma&, to be a recognised facility for producing the active pharmaceutical ingredient (API), peginterferon alfa-2a.
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This allows pharma& to begin Pegasys product replenishment across the United Kingdom (UK) and further strengthens the long-term supply chain stability of the medicine. pharma& anticipates eligible patients in the UK should start to experience improved Pegasys availability in the coming weeks.
“We are delighted that the MHRA has granted approval for the production of Pegasys API at Loba biotech. This marks a critical step forward, building on the recent EMA approval, securing the path forward for Pegasys replenishment across the United Kingdom,” said Elmar Zagler, founder and managing director, pharma&. “Since acquiring Pegasys, pharma& has remained dedicated to maintaining continuous access to this medicine for eligible patients. The MHRA’s approval, along with our investment in Loba biotech, represents pharma&’s ongoing commitment to preserving the availability of essential medicines and foster their development 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 its acquisition of Pegasys, pharma& encountered a surge in 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 the United Kingdom and Europe remains 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.