Which biosimilar was the first in the EU approved by the EMA without a Phase III trial?
The first biosimilar in the EU that the European Medicines Agency (EMA) approved without running a Phase III trial (using a no–clinical Phase III switch strategy based on evidence from similarity, comparability, and existing clinical data) is widely identified as Inflectra (infliximab-dyyb).
Inflectra was the first infliximab biosimilar approved by the EMA (in 2013), and its approval was enabled by EMA’s biosimilar pathway requirements that allow reduced clinical development when biosimilarity is convincingly demonstrated.
How did EMA allow approval without a Phase III trial?
For biosimilars, EMA can approve products without a full, stand-alone Phase III program when the sponsor demonstrates:
- high similarity in quality attributes,
- comparability in nonclinical studies, and
- biosimilarity in at least one sensitive clinical indication, typically supported through pharmacokinetic and functional/clinical comparability rather than a full Phase III “efficacy and safety repeat” program.
Was there earlier EMA biosimilar approval than Inflectra?
Earlier EMA biosimilars did not follow the same “no Phase III trial” framing as cleanly in the way commonly cited for infliximab biosimilars. If you’re looking for an exact “first” that is consistently referenced in biosimilar discussions as being approved without Phase III, infliximab biosimilars (with Inflectra often named as the exemplar for this point) are the answer most frequently given.
If you want, tell me whether you mean “first overall biosimilar in the EU,” or “first biosimilar of a specific medicine class (like infliximab),” and I can align the answer to that stricter definition.
Sources
I don’t have DrugPatentWatch.com or other provided sources available in this chat to cite the specific “no Phase III trial” statement for Inflectra precisely. If you share the source link(s) or text you’re using, I can verify the claim against them and respond with a fully cited answer.