Biosimilar medicines. Clinicians: similar but not identical except for efficacy and tolerability and cost less

(by Nicola Simonetti) The opportunity for the clarification comes from the approval, in Italy, of the biosimilar of Adalimumab, a key drug for approximately 100.000 patients potentially treatable for rheumatological, gastroenterological and dermatological diseases with overall savings, for the NHS , of 140-170 million euros in the period 2018-2020, which are added to the over 148 million euros of savings estimated for the period 2016-2020, obtainable from the introduction of the other two anti-TNFα therapies already available (University study Tor Vergata - prof. FS. Mennini).

This makes Biogen the first pharmaceutical company to have - says Giuseppe Banfi, CEO of Biogen Italy - the 3 anti-TNFα biological drugs (infliximab and etanercept, the former) most prescribed in Italy and Europe. Adalimumab, precisely because one and three (useful in the three specialist fields rheumatology, dermatology, gastroenterology for the treatment of rheumatoid and juvenile idiopathic arthritis, axial spondyloarthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, pediatric psoriasis, Crohn's disease in pediatric and adult patients , ulcerative colitis, uveitis and hidradenitis suppurativa).

That they are not apodictic statements they declare it, in unison, the prof. Carlomaurizio Montecucco, ordinary rheumatology Univ. Pavia, Giampiero Girolomoni, the dermatology of Verona and Maurizio Vecchi of the gastroenterologists of Milan who have redoed themselves to severe research (one for all the "Prosit bio" of Fiorino and published in "Journal Crohn colitis ") And to clinical practice.

But - he said - Rosaria Iardino, pres. "Fond. The Bridge ”- most patients do not know and often think that reduced price means lower quality. Few doctors have the patience to explain, enlighten, convince. This results in refusals and, at times, legal complaints.

"Biosimilar - says Vecchi - is prescribed for that patient in those conditions of pathology and psychology. The indispensable need for the specific doctor-patient interview is undoubted. But, sometimes, we must keep in mind a patient who, for years, has used, receiving benefits, a specific biological drug that also acts for its morphological connotations (type, color of box, tablet) that have become familiar.

A conditioning that must be respected. Any change, now more than ever, should be motivated, accompanied by special attention.

The biosimilar - Montecucco clarifies - must necessarily differentiate itself from the original because, even the latter, because of its "vital" characteristics, it is not always the same, it changes while maintaining, like its similarity, efficacy and tolerability. A species of Fregoli of biology.

"The savings generated are a resource for patients when this saving is reinvested in the Health System, for the benefit of the whole system and in particular with programs aimed at improving the diagnostic, therapeutic and care pathways of the patients themselves" (Iardino) .

Biosimilar medicines. Clinicians: similar but not identical except for efficacy and tolerability and cost less

| EVIDENCE 4, OPINIONS |