Procurement of biosimilar medicines in public tenders: Regulatory framework and recent caselaw

In addition, public tenders for biosimilars are also subject to special rules concerning, in particular, the methods for drawing up the tender and the composition of the lots, as well as the awarding of supplies to private operators. Public purchasing bodies that launch tenders must comply with these specific rules or face the risk of litigation and annulment of the awards.

Biological and biosimilar products

Biological medicines are defined as those whose active ingredient is a substance produced or extracted from a biological system or derived from a biological source by biotechnological processes, as opposed to traditional medicines whose active ingredient is chemically derived.

Biosimilars, in turn, are medicines that are “similar” to a reference biological/biotechnological product that is already authorised and off-patent, and that have the same biological active ingredient. However, biosimilars and originators may have minor differences due to natural variability and manufacturing techniques that prevent the recognition of a substantial equivalence between them, even if they have the same active substance and therapeutic indications^[1].

Regulatory approval and dispensing

Biosimilar products are approved by the European Medicines Agency (EMA) after a “comparability exercise” has demonstrated that their natural variability and differences from the reference medicine do not affect their safety and efficacy profiles.

At national level, approved biosimilars are recognised by the Italian Medicines Agency (AIFA) as “interchangeable” with the corresponding originator products, both for patients starting treatment for the first time and for those already on therapy, as specified in an AIFA Position Paper on the subject. This means that biosimilars with equivalent clinical efficacy can replace their originator for treatment purposes.

However, due to the lack of substantial equivalence between biosimilars and originators, the law does not allow automatic substitution between the reference biological medicine and its biosimilar, nor between different biosimilars. Substitution by the pharmacist must always occur only after consultation with the prescribing doctor^[2]. The choice of treatment remains a clinical decision entrusted to the doctor and agreed upon with the patient, who cannot alter the prescription received.

Composition of the tender lot: a recent decision of the Administrative Court of Piedmont

The characteristics of biosimilar medicines, as described above, influence the structuring of public tenders. As a general rule, Italian law provides that biosimilar drugs with different active ingredients cannot compete against each other in tender procedures (i.e., in the same lot), even if they have the same therapeutic indications (Article 15, paragraph 11-quater, of Legislative Decree no. 95/2012).

Administrative jurisprudence has recently clarified this rule, particularly in a case where AIFA had issued a declaration of therapeutic equivalence between the respective originators of two biosimilars with different active ingredients and the same therapeutic indication^[3]. Even in this scenario, according to the Court, the two biosimilar medicines cannot compete against each other in the same lot, nor can the declaration of equivalence between the two biological originator medicines extend to their respective biosimilars and legitimize the inclusion of the products in the same tender lot. Indeed, this would have triggered a breach of the legal prohibition under Article 15 above.

Conversely, it is permissible to place in competition in the same lot (a) an approved biosimilar with its biological originator reference product; and (b) two biological originator products with different active ingredients that have been declared equivalent by AIFA.

Rules concerning the awarding and supply of biosimilars with the same active ingredients

In case of awarding through a single tender lot, if more than three biosimilar medicines are admitted to the tender, Italian law provides that central purchasing bodies concerned enter into a framework agreement with all the economic operators holding the products (Article 15, paragraph 11-quater, of Legislative Decree no. 95/2012).

Then, with regard to the implementation of the agreement, the same article stipulates that, as a general rule, “patients must be treated with one of the first three medicines in the ranking of the framework agreement, classified according to the criterion of the lowest price or the most economically advantageous offer“, thus ensuring lower costs and greater possibilities of obtaining medicines with the same resources (since the operators higher in the ranking have offered more advantageous economic conditions).

In any case, the rule always specifies that the doctor is always free to prescribe a biosimilar drug admitted to the tender procedure and classified beyond the third place in the ranking if considered more suitable to ensure therapeutic continuity for patients. The prescription can occur at the expense of the NHS.

Conversely, according to the same Article 15 as interpretated by the administrative caselaw^[4], the prescription of a biosimilar for which an offer has been presented but that has not been admitted to the procedure – e.g., in cases of offers exceeding the base price – is permissible if requested by the doctor, but the related costs must be borne by the patient or the medical institution, rather than the NHS. This approach addresses the need for expenditure containment and resource rationalization while safeguarding the principle of the doctor’s freedom to prescribe the treatment deemed most suitable for the patient.

[1] As further specified by the Regional Administrative Court of Piedmont, Section II, in its ruling no. 465 of 14 July 2020: “Biological/biotechnological medicines differ in many respects from those produced by chemical synthesis in traditional pharmacology: the biological product has larger molecules, structural complexity, a different stability of the final product; there are generally aspects of heterogeneity related to the host cell used, which the patient’s organism can recognise as foreign, triggering the consequent immune response; thus, between different biological medicines containing the same active substance, there are differences in materials and processes that determine the uniqueness of each biological product, and sometimes even differences between different batches of the same product. In any case, the intrinsic variability of the molecules of these medicinal products, the complexity of the production techniques and their so-called immunogenic potential mean that, for the purposes of marketing authorisation, the regulatory authorities require detailed information on the production process, on the immunogenic potential and on the safety issues that may arise, in order to characterise and control the quality and safety of the medicinal products”.

[2] Automatic substitution (of equivalents) by pharmacists refers to the practice whereby the pharmacist has the right, or is required by national or local regulations, to dispense an equivalent and interchangeable medicine instead of the prescribed one, without consulting the prescribing doctor.

[3] See Regional Administrative Court of Piedmont, Section II, Judgment no. 979 of 30 September 2024, issued in the context of a tender for the supply of biosimilar medicines to regional healthcare facilities.

[4] Regional Administrative Court of Piedmont, Section II, Judgment no. 465 of 14 July 2020.