Roche opens door to generic production of Xofluza in developing world

Swiss drugmaker's deal with UN-backed body could sharply cut cost of single-dose flu treatment across 129 low- and middle-income countries

ROCHE (RHHBY) has agreed to allow generic manufacturers to produce its influenza antiviral baloxavir marboxil, signing a voluntary licence with the Medicines Patent Pool in a move that could significantly expand access to the drug across the developing world.

The agreement with MPP, a United Nations-backed public health body, permits generic companies to develop, manufacture and supply baloxavir in 129 low- and middle-income countries. MPP has invited prospective suppliers to submit details of their manufacturing capacity, capabilities and quality-assurance track record.

Roche, which sells the drug as Xofluza through its Genentech unit, introduced a direct-to-patient pricing scheme in the US last year, offering the antiviral to cash-pay patients at $50 — roughly 70 per cent below list price. Generic competition in lower-income markets could push prices considerably further down.

MPP's model, which has been applied to HIV treatments since the body struck its first licensing deal in 2011, has helped reduce the annual cost of one HIV drug to $70 in Africa, compared with $10,000 in Europe, according to Marisol Touraine, chair of the executive board of Unitaid, MPP's principal backer.

Baloxavir has featured on MPP's priority licensing list since at least its 2024 annual report, reflecting longstanding interest in securing access to the treatment. The organisation noted in 2023 that the drug was available in only a small number of low- and middle-income countries, and at prices generally higher than those of oseltamivir — the older antiviral Roche markets as Tamiflu. Clinical data show the two medicines perform similarly in reducing the duration of influenza symptoms, though baloxavir requires only a single oral dose against a five-day, twice-daily regimen for oseltamivir.

The simplicity of baloxavir's manufacturing process was a factor in MPP's decision to target the licence. The drug is produced using standard tablet manufacturing with no unusual excipient or packaging challenges, MPP said. To support generic entry, Roche has committed to providing manufacturers with a foundational data package, reference products for bioequivalence studies and the necessary regulatory waivers.

While most of MPP's existing portfolio covers HIV, the organisation also holds licences for treatments spanning hepatitis C, tuberculosis and cancer.

The agreement carries explicit pandemic provisions. Should a global influenza outbreak occur, Roche and MPP have committed to work together to dismantle access barriers, including supply constraints, territory restrictions and royalty obligations.