Molly and MIDBA streamline mAb development programs

Summary

The EMA’s 2026 qualification of MIDBA enables a more efficient transition from pre-filled syringes to autoinjectors for monoclonal antibodies. Reusing existing pharmacokinetic data reduces the need for dedicated bridging studies, accelerating timelines and lowering costs. Molly meets all key device criteria and is well represented in the underlying dataset. However, MIDBA remains limited by regional scope, reference data requirements, and applicability to specific biologics.

Key takeaways

• MIDBA introduces a meaningful opportunity to reduce bridging studies and accelerate device-enabled therapies across biologics portfolios.
• Molly meets all key technical device parameters within the MIDBA framework and benefits from SHL Medical’s strong representation in the underlying dataset.
• MIDBA is limited by geographic scope, reference dataset requirements, and drug modality.
• MIDBA should be regarded as a strategic tool within limits, rather than a universal justification for eliminating the need for device-bridging studies.

Document details

• Format: Technical memo
• Author/Spokesperson:SHL Medical
• Page count: 2 pages
• Estimated read time: ~4–5 minutes