EMA’s bioequivalence guidance pipeline gives generics teams a 2026 watchlist

What happened

EMA will hold its sixteenth industry stakeholder platform on research and development support on 2 July 2026 in Amsterdam. The agenda includes a follow-up discussion on product-specific bioequivalence guidance, alongside broader development-support topics such as scientific advice, PRIME, qualification of novel methodologies, real-world evidence and regulatory sandboxes.

The meeting follows EMA’s update to its product-specific bioequivalence guidance page, which now lists expected 2026 guidance candidates. The list includes aripiprazole, cladribine, etonogestrel, liraglutide, semaglutide, tafamidis and tofacitinib. EMA recorded the update on 19 May 2026.

Why it matters

For generic and hybrid developers, the update is a portfolio-planning trigger. Product-specific BE guidance can affect study design, analyte selection, fasting or fed conditions, dose strength selection, comparator sourcing and biowaiver strategy.

The timing also matters because sponsors are still working through the EU implementation of ICH M13A, which became effective on 25 January 2025. M13A replaces parts of EMA’s older BE guideline for immediate-release solid oral dosage forms, but it does not remove the need to check remaining EMA guidance, Q&As and product-specific requirements.

The practical risk is simple: a sponsor may lock a BE protocol before EMA publishes product-specific expectations for a relevant product.

Who should care

• Generic and hybrid developers with products on or near EMA’s 2026 BE guidance list.
• Clinical pharmacology and biostatistics teams preparing BE protocols or SAPs.
• Regulatory affairs teams planning scientific advice or EU submission strategy.
• Portfolio teams tracking high-value generic or hybrid opportunities.
• CMC and formulation teams making early choices on strength, formulation or comparator strategy.

Actions to take now

1. Check the 2026 list against the pipeline. Flag any internal programs involving the listed products or closely related development strategies.

2. Review BE protocols against ICH M13A. Confirm that current templates reflect the M13A framework where applicable.

3. Build a single BE crosswalk. Map ICH M13A, remaining EMA guidance, EMA Q&As and product-specific guidance into one program-level checklist.

4. Do not wait for final guidance. For products on the expected-guidance list, consider whether pilot or pivotal BE work should pause, adapt or seek advice before major costs are incurred.

5. Use scientific advice for uncertain cases. Complex products, high variability, NTI concerns, comparator uncertainty or biowaiver questions should be raised before protocols are finalised.

What to monitor next

The immediate watchpoint is the 2 July 2026 EMA stakeholder-platform discussion and any slides or meeting report that follow.

Companies should also monitor EMA’s product-specific BE page for draft or final guidances tied to the 2026 candidates, and continue tracking further ICH M13 implementation steps.

Bottom line

This is not just a meeting notice. EMA has made its 2026 product-specific BE priorities more visible. Generic and hybrid developers should use that list now to stress-test BE plans, protocol templates and scientific-advice questions before development decisions harden.

Sources

• EMA: “Sixteenth industry stakeholder platform on research and development support”
• EMA: “Product-specific bioequivalence guidance”
• EMA: “ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms”
• EMA: “Considerations regarding the implementation of ICH M13A”
• EMA: “Streamlining product-specific bioequivalence guidance”