HPE HPE Fresenius Kabi handbook - Page 3

Foreword Giampiero Girolomoni MD Paolo Gisondi MD Department of Medicine, Section of Dermatology and Venereology, University of Verona, Italy The introduction of biological agents (monoclonal antibodies and fusion proteins) in the early 1990s dramatically changed the clinical management and the course of immune-mediated inflammatory diseases, such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis, Crohn’s disease (CD) and ulcerative colitis (UC). In particular, tumour necrosis factor (TNF) alpha-blockers, such as infliximab, etanercept and adalimumab, represent a tremendous advancement. Prolonged maintenance therapy with anti-TNF agents has been shown to avoid severe complications in inflammatory bowel disease as well as reduce the need for surgery and hospitalisation. In the case of PsA, RA and AS, treatment with TNF blockers achieves rapid disease control and prevents long-term radiographic progression and irreversible joint damage. Patients with psoriasis were astonished to see very fast clearance of skin lesions when starting anti-TNF antibodies. The rapid and sustained improvement in patients’ quality of life offered by these treatments has never been so intense before. More recently, it has been shown that early treatments of CD, UC and RA can alter disease course with early remission and long-term benefits. Finally, the long-term experience with these drugs and the data from very large national registries worldwide is very reassuring as far as the long-term safety concerns. The main restriction to the use of biologics is related to their cost. Biologics are very complex and large molecules produced by living cell cultures, thus requiring large technological investments. The use of biologics for patients with chronic disease might be very expensive over time, especially for national healthcare systems. Several studies across different specialties have indeed shown that the main limitation to biologics use is the cost, followed by safety concerns. Biosimilars represent an important and direct opportunity for reducing the cost of biologic therapy. Biosimilars are biologic products developed using a step-wise approach to result in a biologic that demonstrates no clinically meaningful differences in terms of quality attributes, efficacy, safety, and immunogenicity compared with an existing licensed, reference biologic. Anti-TNF biosimilars offer direct cost savings, which might support healthcare sustainability and would further increase patient access to biologic therapy. Lower drug cost might indeed translate into an earlier, optimal and equal access to these very effective and consolidated treatments. US Food and Drug Administration and European Medicines Agency regulatory pathways for approving biosimilar are very stringent and allow only high quality manufactured biosimilars to enter the market. A major issue with biosimilars is extrapolation, that is, the use of the drug in a disease in which the biosimilar has not been directly tested but the reference is indicated. However, data from registries and studies are accumulating and provide reassurance to healthcare professionals and the public that the risk of immunogenicity-related safety concerns or diminished efficacy is unchanged after switching from a reference biologic to a biosimilar medicine. Interchangeability and traceability are also very relevant to provide a reliable identification system, related to all production and distribution phases, both the reference and the biosimilar used in clinical practice, so that possible adverse events can be certainly identified for each product. The importance of an uninterrupted supply of biological drugs, including biosimilars, is also very important to avoid drug shortages and ensure optimum drug efficacy. In conclusion, biosimilars offer a very important opportunity to effectively treat patients in need. Health care professionals (physicians and pharmacists) should share their experiences and concerns for an optimal usage in patients. Issues related to immunogenicity, interchangeability, automatic substitution and extrapolation of indications should continue to be studied and debated for the benefit of patients. hospitalpharmacyeurope.com | 2019 | 3