Mabion Signs Rare Disease Deal with Oddifact to Reactivate MabionCD20 Biosimilar Candidate

A shelved biosimilar candidate is returning to active development under a rare disease framework, a pivot that carries direct implications for how Mabion's manufacturing and regulatory teams will need to reposition the program. Mabion has signed a collaboration agreement with Oddifact to advance MabionCD20, a monoclonal antibody originally developed as a biosimilar to MabThera and Rituxan (rituximab), into a rare disease indication.

The strategic shift moves MabionCD20 out of the crowded rituximab biosimilar field and into orphan indication territory, where the regulatory pathway diverges substantially. Rather than demonstrating biosimilarity under 21 CFR Part 601 or equivalent EMA guidelines, the program will now need to satisfy efficacy and safety requirements specific to the target rare disease, alongside any orphan drug designation criteria. For regulatory affairs leads, that means rebuilding the dossier architecture around a new indication rather than a reference product comparability exercise.

From a manufacturing standpoint, the transition is not straightforward. Biosimilar development typically drives process optimisation toward cost-of-goods efficiency at commercial scale. Rare disease programs, by contrast, often require smaller batch sizes, tighter patient-specific supply controls, and heightened sterility assurance protocols given the vulnerability of the target population. Any existing process validation packages built around biosimilar-scale assumptions will require reassessment against the new clinical and commercial demand profile.

The collaboration structure with Oddifact, a company focused on rare and orphan disease development, suggests Mabion is contributing the manufacturing platform and existing molecule data package while Oddifact brings the indication-specific clinical and regulatory expertise. The division of responsibilities has direct consequences for quality agreements, technology transfer scope, and how ICH Q10 pharmaceutical quality system obligations are allocated between the two organisations.

The extent to which existing analytical and process characterisation data generated under the biosimilar program can be bridged into the rare disease submission will be a key determinant of development timelines and cost.

Source: Media4Growth via Indian Pharma Post, 15 June 2026.