HPE Biosimilars: Where are we and what is next? - Page 3


Giampiero Girolomoni MD Paolo Gisondi MD Department of Medicine , Section of Dermatology and Venereology , University of Verona , Italy
Biologics are now essential treatments across many chronic diseases , including immunemediated inflammatory diseases such as rheumatoid arthritis ( RA ), ankylosing spondylitis , psoriatic arthritis ( PsA ), psoriasis , Crohn ’ s disease and ulcerative colitis . Early treatment with tumour necrosis factor ( TNF ) blockers alters disease course with prolonged disease remission and long-term benefit , including prevention of radiographic progression and irreversible joint damage in RA or PsA , or reduction of surgery and hospitalisation in inflammatory bowel disease . In addition , the long-term experience with these drugs and the data from very large national registries worldwide are very reassuring as far as the long-term safety .
In particular , concerns about severe infection and cancer with the use of biologics have been progressively mitigated with the availability of real-world long-term data . However , biologics are expensive drugs and patient access may be restricted . Indeed , several studies across different specialties have shown that the main limitation to biologic use is the cost , followed by safety concerns . Loss of patent protection of a number of biologics , coupled with advances in technological innovations and biomanufacturing , has led to a reduction in the time and cost to develop new biologic drug products . The development of high-quality biosimilars definitely offers a cheaper , yet equally effective , alternative to original biologics . Biosimilars represent an important and direct opportunity for reducing the cost of biological 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 , originator biologic . European and US regulatory pathways for approving biosimilars are very stringent and allow only high-quality manufactured biosimilars to enter the market . Anti-TNF biosimilars offer direct cost savings , which may support healthcare sustainability and further increase patient access to biologic therapy . In many instances , cost savings may be very relevant , with cost reductions of more than 80 % compared with the biologic originator . Lower drug cost is already translating into an earlier , optimal and equal access to these very effective and consolidated treatments . In the case of several immune-mediated inflammatory diseases , biosimilars are cheap enough to be used as first-line treatments .
In the face of ever-increasing healthcare costs and cost-cutting initiatives , switching patients from reference adalimumab , etanercept or infliximab to a lower cost biosimilar , and starting biologic-naïve patients on the best-value biologic can lower prices for patients and payers without compromising quality of care . An important concern about the use of biologics and biosimilars is an uninterrupted supply in order to avoid shortages and ensure continuous drug efficacy . In the event of a drug shortage , whereby the company cannot supply the market with recently produced drugs , drug batches with different expiry dates and potentially different quality profiles and activities will be on the market , pointing to the importance of pharmacovigilance at batch level , and the importance of batch traceability .
Educating health care professionals ( pharmacists , physicians and nurses ) and patients about the scientific principles underlying biosimilar development and approval and real-world clinical experience with these drugs may lead to greater and more effective use of biologics in clinical practice . 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