LIFE SCIENCES | The Council of State on the Therapeutic equivalence between originator biological medicinal products and biosimilars

The case originates from a public tender launched by the Piedmont Region for the supply of medicinal products intended for the treatment of neovascular age-related macular degeneration (AMD), in which the same lot included: two originator biological medicinal products with different active substances (Ranibizumab and Aflibercept), considered therapeutically equivalent by AIFA in 2014; and the biosimilar of the Ranibizumab originator (thus having the same active substance), made available after the expiry of the originator’s patent.

The holder of the Aflibercept originator challenged the award of the tender to the biosimilar of the Ranibizumab originator, claiming the unlawful commingling within the same lot of a biosimilar (subsequently awarded the tender) and an originator with a different active substance.

The Regional Administrative Court of Piedmont (TAR-Piemonte) (by judgment No. 979/2024) and the Council of State (by the recent judgment of June 11, 2025 No. 5025) confirmed that, pursuant to Article 15, paragraph 11-quater of Law Decree No. 95/2012, it is prohibited to include within the same lot biosimilars with different active substances. Therefore, if it is true that biosimilars with different active substances cannot be put in competition, it is equally true that a biosimilar and an originator with different active substances cannot be put in competition in the absence of the bioequivalence assessment issued by AIFA. In essence, the transitive property does not apply: to assert that the biosimilar is also equivalent to the originator Aflibercept, a new and the specific note of therapeutical equivalence by AIFA is therefore required for the biosimilar, which has never been carried out in this specific case.

Article 15, paragraph 11-ter of Law Decree No. 95/2012 allows for the equivalence between medicinal products with different active substances only following an opinion issued by AIFA, as occurred for the two originators with active substances Ranibizumab and Aflibercept considered therapeutically equivalent, and therefore lawfully included in the same lot. In the absence of a specific AIFA opinion on the equivalence of the biosimilar with respect to the different active substance, the mixed lot is therefore unlawful.

Newsletter n. 109 – July 2025