Vienna, Austria, August 19, 2026 – pharmaand GmbH (pharma&) today announced that the U.S. Food and Drug Administration (FDA) has approved a Prior Approval Supplement (PAS) for Pegasys® (peginterferon alfa-2a), for the registration of Loba biotech GmbH, a wholly owned manufacturing subsidiary of pharma&, to produce the active pharmaceutical ingredient (API) peginterferon alfa-2a. This approval reinforces the long-term stability of the U.S. supply, ensuring continuity of care for eligible patients.
“We are delighted that the FDA has granted PAS approval so peginterferon alfa-2a can be produced at Loba biotech GmbH – this follows approvals from other regulatory agencies across the globe,” said Elmar Zagler, Co-Founder and Managing Director, pharma&. “Since acquiring peginterferon alfa-2a in 2021, pharma& has committed to maintaining access to the medicine for eligible patients, and this approval marks a significant step in supporting continuous supply in the U.S. and underscores our ongoing commitment to patients.”