Roche pivots to future-proof MS drug against biosimilar pressure

Roche is supporting the transition of multiple sclerosis (MS) patients from intravenous (IV) to subcutaneous (SC) Ocrevus (ocrelizumab) as the pharmaceutical company seeks to reduce pressure on infusion services and strengthen the position of its SC formulation ahead of anticipated biosimilar competition.

The strategic shift comes as Ocrevus IV is expected to become the first formulation of the medicine exposed to biosimilar competition, with the subcutaneous formulation providing Roche with additional patent protection.

Earlier this month, Teva Pharmaceutical and Polpharma Biologics entered a global licensing agreement for IV and SC biosimilar versions of Ocrevus across Australia, New Zealand and other international markets. Teva will manage regulatory submissions and commercialisation activities under the agreement.

While both forms of Ocrevus are designed to be administered twice yearly, the SC injection can be delivered in approximately 10 minutes compared with several hours required for an IV infusion. The trade-off is a higher incidence of local injection-site reactions with the SC formulation, reported in around 48% of patients, including mild-to-moderate redness, pain, swelling, itching and bruising.

For Roche, shifting eligible patients from IV to SC Ocrevus represents a significant strategic opportunity, delivering measurable time savings and a substantial care-time dividend within high-pressure infusion units. However, implementation remains complicated by current funding structures, with no Medicare Benefits Schedule (MBS) item number available for clinics administering the SC formulation outside an infusion centre.

The pressure on infusion capacity remains a significant concern for clinicians. While MBS funding covers IV infusion services delivered in public hospitals with no out-of-pocket costs to patients, several neurologists told Health Industry Hub that extended wait times continue to present a major challenge. By contrast, privately insured patients benefit from more timely access to infusion services in private hospitals but face out-of-pocket costs of up to $800–$1000 per infusion.

Neurologists told Health Industry Hub that Roche supports clinics through arrangements that enable eligible public patients prescribed Ocrevus IV infusion to access treatment via private infusion centres or home infusion services, by covering the associated out-of-pocket costs for induction and maintenance therapy.

The arrangement has prompted clinicians to call on other companies supplying MS therapies requiring IV administration to introduce similar support models. However, Roche has advised some clinicians that this arrangement is likely to end in January 2027, including at Ramsay hospitals.

Against this backdrop, the previously announced Pharmaceutical Benefits Advisory Committee (PBAC) review of MS drugs including Kesimpta (ofatumumab), Ocrevus and Briumvi (ublituximab), is expected to be completed by December.

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