MHRA approves Loba Biotech to manufacture Pegasys API, enabling pharma& to strengthen UK supply and ensure continued access for eligible patients.
An antiviral used to treat hepatitis B and C | Image Credit © luchschenF
pharmaand GmbH (pharma&) has received a regulatory variation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), authorizing its wholly owned subsidiary, Loba biotech GmbH, as an approved manufacturing site for the API in Pegasys (peginterferon alfa-2a), according to a May 28, 2025 news release from the company (1). This regulatory update marks a significant milestone in stabilizing the long-term supply chain of Pegasys in the United Kingdom and enables the company to begin product replenishment across the region.
Following the MHRA decision, pharma& expects that eligible patients in the UK will begin to see improved access to Pegasys in the coming weeks.
“We are delighted that the MHRA has granted approval for the production of Pegasys API at Loba biotech GmbH. This marks a critical step forward, building on the recent EMA [European Medicines Agency] approval, securing the path forward for Pegasys replenishment across the United Kingdom,” said Elmar Zagler, founder and managing director of pharma& (1).
·MHRA approval of Loba Biotech enables in-house Pegasys API production, reinforcing pharma&'s control over its biologics manufacturing process.
·UK Pegasys supply chain gains long-term stability as pharma& scales bio-manufacturing capacity at its Loba Biotech facility.
·pharma&’s investment in Pegasys API production reflects growing industry focus on supply chain resilience for essential biologic therapies.
The decision to invest in internal API manufacturing capabilities followed pharma&'s acquisition of Pegasys from F. Hoffmann-La Roche AG in 2021 (2). Roche had announced in 2019 that it would cease global commercialization of the product (1). Since then, pharma& has prioritized uninterrupted patient access to Pegasys, with a particular focus on markets affected by supply shortfalls.
Following the acquisition, pharma& observed a surge in demand for Pegasys, leading the company to invest in bio-manufacturing infrastructure at Loba biotech GmbH. The regulatory approval for this site underscores the company's commitment to securing reliable access to critical therapies.
“Since acquiring Pegasys, pharma& has remained dedicated to maintaining continuous access to this medicine for eligible patients,” Zagler added (1). “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.”
While supply restoration in the UK and Europe is advancing, pharma& also continues to work closely with regulatory bodies in other regions, including the United States, to support expanded access for eligible patients.
Pegasys is a pegylated type I interferon (IFN), primarily interferon alfa-2a, according to the release (1). Type I interferons—including IFN-α, IFN-β, IFN-ε, IFN-κ, and IFN-ω—are a class of alpha-helical cytokines central to innate and adaptive immune responses, with evolutionary origins tracing back approximately 500 million years. These proteins exert antiviral effects by binding to the interferon-α receptor (IFNAR), composed of IFNAR1 and IFNAR2 subunits.
Pegylation of interferon alfa-2a involves the covalent attachment of a branched polyethylene glycol (PEG) molecule, resulting in the formulation known as Pegasys (1). The 40-kilodalton PEG moiety enhances pharmacokinetics by acting as a protective barrier and extending systemic exposure.
In the UK, Pegasys has been authorized for the treatment of chronic hepatitis B (CHB) in adults and children aged three years and older, as well as chronic hepatitis C (CHC) in adults and children aged five years and older (1). CHC treatment in pediatric patients is approved in combination with ribavirin.
Full safety information and the Summary of Product Characteristics for Pegasys are accessible through the MHRA (3).
References
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