European Medicines Agency approves new API manufacturing site for pharma&’s Pegasys

The European Medicines Agency (EMA) has approved a variation to the marketing authorization for Pegasys (peginterferon alfa-2a), adding Loba biotech GmbH in Austria as a designated site for active pharmaceutical ingredient (API) manufacturing.

Loba biotech is a wholly owned subsidiary of privately owned company pharmaand GmbH (pharma&). The decision enables pharma& to begin replenishing supplies of Pegasys across Europe, addressing prior shortages and aiming to restore access for eligible patients.

The approval follows pharma&’s 2021 acquisition of global rights to Pegasys from F. Hoffmann-La Roche, which had announced plans to discontinue commercializing the product worldwide in 2019.

Since acquiring the product, pharma& has faced increasing demand, prompting the company to invest in internal manufacturing capabilities to stabilize the drug’s supply. The addition of Loba biotech as an authorized API site is part of that broader effort to secure long-term production capacity.

Pegasys, a pegylated type I interferon, is authorized in the European Union and other markets for the treatment of several conditions, including polycythaemia vera, essential thrombocythemia, chronic hepatitis B, and chronic hepatitis C.

In August 2024, the European Commission approved Pegasys as monotherapy in adults for polycythaemia vera and essential thrombocythemia. It is also approved for hepatitis B in adults and children aged 3 and older, and for hepatitis C in adults and kids aged 5 and older in combination with other treatments.

While the focus is currently on restoring access within Europe, pharma& has stated that it is working with regulatory authorities in the U.S. and other regions to expand Pegasys availability globally.