Qualitative differences among teriparatide-based pharmaceuticals

Background. Osteoporosis is a systemic skeletal disease affecting about 5 million people in Italy of which near 80% are post-menopausal women with an increased risk of both vertebral and non-vertebral fractures. Among drug therapies included in AIFA Note 79 for postmenopausal primary osteoporosis or glucocorticoidinduced secondary osteoporosis, teriparatide is the only drug with anabolic action on the skeletal system according to AIFA Note 79. Differences were highlighted at regulatory level since, drugs based on the same active ingredient were registered with different procedures. Following the patent expiry of teriparatide originator, two biosimilar products and a pharmaceutical product manufactured by chemical synthesis will be released to the market. The objective of this paper is to provide an analysis of the different teriparatide-based products and to identify differential quantifiable parameters that the Contracting Authorities and / or Regional Purchasing Centers could apply if decide to start an evaluation of tenders for pharmaceutical procurement on teriparatide-based pharmaceuticals according to the quality/price ratio. Methods. A preliminary questionnaire concerning different teriparatide-based products on diverse topics divided into themes and sub-themes including: scientific evidence, regulatory polices, management and organizational supply was administered to a Group of experts consisting of: clinicians, a clinical engineer, a pharmacologist, a pharmacist and a Nurse PhD. The questions that required an affirmative or negative answer were analyzed, divided into sub-themes, and were subject to in-depth analysis and discussion during the meeting between the members of the Group of experts (25 June 2019). Results. From the responses to the preliminary questionnaire and the comparison between the group of experts, it emerged that differences among biotechnological teriparatide and its synthetic equivalent drug concerning excipient composition, pharmacokinetic and pharmacodynamic characteristics, and production process did not significantly affect the drug efficacy. Differences were highlighted at regulatory level since, in an unprecedent scenario, drugs based on the same active ingredient were registered with different procedures. Characteristics of the subcutaneous administration device and the presence of patient support programs (PSP) delivered together with the product were considering as impacting from the point of view of implementation of adherence to therapy. The Group of experts has identified and classified parameters extrinsic to the active ingredient and / or intrinsic to the device, classifying them as subjective or objective; the latter have been attributed a possible weight that the Contracting Stations, could apply if decide to start an evaluation of tenders for pharmaceutical procurement on teriparatide-based pharmaceuticals according to the quality/price ratio. Conclusion. To date, Contracting Authorities are more inclined to award tenders among products based on the same active ingredient according to the most economically advantageous offer, as they have standardized characteristics. This analysis wants to highlight new parameters that creating a qualitative difference among teriparatide-based products may shed light to a possible tender evaluation on the basis of the quality/price ratio rather than on the most convenient price. © 2021 Il Pensiero Scientifico Editore s.r.l.. All rights reserved.