The European Medicines Agency (EMA) has granted a variation to the Marketing Authorization for Pegasys® (peginterferon alfa-2a), allowing Loba biotech GmbH to produce the active pharmaceutical ingredient (API). This approval enables pharma& to begin replenishing Pegasys supplies across Europe, with improved availability expected for eligible patients in the coming weeks.
Loba biotech, located in Austria, is a wholly owned manufacturing subsidiary of pharmaand GmbH (pharma&). The authorization marks a significant milestone in addressing supply challenges that have affected patient access to this essential medication.
"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 of pharma&. "Since acquiring Pegasys, pharma& has been committed to ensuring this important medicine's continuous availability to eligible patients."
Background on Pegasys Supply Challenges
In 2019, F. Hoffmann La Roche AG (Roche) announced it would cease commercializing Pegasys globally. Recognizing the medication's importance, pharma& acquired the global rights to Pegasys in 2021, intending to ensure continuity of care for patients who rely on the treatment.
Following the acquisition, pharma& encountered increased product demand, prompting the company to invest in expanding bio-manufacturing capabilities at Loba biotech. This investment was crucial for establishing the new production capacity needed to manufacture peginterferon alfa-2a, the active ingredient in Pegasys.
Therapeutic Applications of Pegasys
Pegasys is a pegylated form of interferon alfa-2a, a type I interferon that plays a role in both innate and adaptive immunity. The medication works by interfering with viral replication within host cells through binding to a specific cell surface receptor complex.
In August 2024, the European Commission expanded Pegasys's indications to include monotherapy for adults with polycythemia vera (PV) and essential thrombocythemia (ET). The medication was previously approved for chronic hepatitis B in adults and children aged 3 years and older, and for chronic hepatitis C in adults and children aged 5 years and older when used in combination with other medications.
The pegylation process, which attaches a large, branched polyethylene glycol (PEG) chain to the interferon alfa-2a molecule, provides a protective barrier that enhances the drug's pharmacokinetic profile.
Global Supply Strategy
While the EMA approval addresses European supply needs, pharma& emphasizes that replenishing Pegasys outside of Europe remains a top priority. The company is actively collaborating with regulatory authorities and partners to enhance availability for eligible patients in the United States and other regions.
"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," Zagler added.
About pharma&
pharmaand GmbH is a privately owned global company dedicated to preserving the availability and advancing the development of essential medicines worldwide. Over the past five years, the company has acquired and integrated more than ten medicines across various therapeutic areas, with an increasing focus on hematology and oncology treatments.
The company's business model integrates subsidiaries, joint ventures, and partnerships to support the full continuum of pharmaceutical development, manufacturing, and distribution, ensuring medicines reach eligible patients globally.
