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