Automatic substitution for biosimilar drugs, scientific societies: "No, it's dangerous"

Rome, 21 September 2020 – “We deeply contest the recent sentence 465/20 of the Piedmont Regional Administrative Court on the supply of biological drugs. It is a decision that will allow the Regions to set the conditions for automatic substitution from an originator drug to its biosimilar, or from one biosimilar to another. This is a dangerous legal precedent which could have consequences and which harms two rights: therapeutic continuity for the patient and prescriptive freedom for the clinician". This is what is claimed in a joint document by seven Scientific Societies (SIR - Italian Society of Rheumatology; SIN - Italian Society of Nephrology; SID - Italian Society of Diabetology; FADOI - Federation of Associations of Hospital Internists; ADOI Association of Dermatologists, Venereologists and Hospitallers; SIGE - Italian Society of Gastroenterology and SIMI - Italian Society of Internal Medicine).

According to the representatives of SIR, SIN, SID, FADOI, ADOI, SIGE and SIMI, the decision effectively establishes the switch, bypassing the clinician. “The judges refer to dated sentences, neglecting all the most recent jurisprudence even of the Council of State. Two rights harmed: prescriptive freedom and therapeutic continuity"

“As representatives of clinicians, we reiterate that we are not against the switch or the multiple switch – underline the seven Scientific Societies -. The advent of biosimilars has, in fact, represented a therapeutic opportunity as well as a system to contain the costs of therapies capable of modifying the course of various chronic inflammatory pathologies. However, the switch for non-medical reasons cannot and must not become an unavoidable practice. It is absolutely necessary to carefully evaluate each individual case and the specific clinical history of each patient before proceeding with this clinical practice. It is a decision that therefore belongs only to the treating specialist and cannot be imposed. Our fear is that the sentence of the Piedmontese court lays the foundations for automatic substitutability. The administrative judges have, in fact, introduced a regulation that only formally respects the principles established by national regulations: such as law 232/2016 on therapeutic continuity. To arrive at these results, the judges refer to outdated sentences, neglecting all the jurisprudence produced on this specific topic in recent years, even by the Council of State. The sentence also leads to the application to biological medicines (originators with respect to biosimilars and between biosimilars themselves) of the discipline on substitutability today exclusively reserved for drugs with chemical composition (brands with respect to equivalents or, in other words, generics). Basically, many patients may be forced to change their treatment plan unless they are willing to purchase the originator drug at their own expense".

“The choice of the Turin court was, in our opinion, dictated solely and exclusively by economic and non-clinical reasons – continue the representatives of SIR; SIN; SID; FADOI; ADOI; SIGE and SIMI -. It has recently been demonstrated by a systematic review of the scientific literature that in patients with chronic inflammatory diseases, treated with originator drugs, the transition to the biosimilar does not lead to a lower efficacy but does record a greater propensity to suspend the treatment. The scientific studies supporting the switch have also led to very heterogeneous results and with low quality scientific evidence. In other words, we do not yet have certain and unequivocal data that can give guarantees to the patient that the switch does not represent a problem. Precisely for this reason we believe that it is wrong to impose it with a sentence ".