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| Biosimilars |
The healthcare industry has seen tremendous improvements over the past few
decades thanks to advancements in technology and research. However, one area
that still posed challenges was the high cost of biologics which are drugs
produced from living organisms. Developing and manufacturing biologics requires
complex technology and extensive clinical research which drives up costs making
these life-saving drugs out of reach for many patients.
Emergence of biosimilars
To address this issue, regulators and researchers have been working on
developing biosimilar drugs which are similar to already approved biologics but
are more affordable. Biosimilars are biologic medical products that are
developed to be similar to an already FDA-approved biologic, which is known as
the reference product (RP). The RP has already been licensed by the FDA. Major
advances in the scientific understanding and manufacturing of biologics have
made it possible to develop highly similar versions of approved products.
The term 'biosimilar' was coined to describe a biologic that is highly similar
to an existing medicine. While biosimilars are similar to their reference
medicine, there may be minor differences in clinically inactive components or
in the manufacturing process which make the price lower than the original
biologic. Multiple global regulatory bodies including the FDA, EMA and WHO have
established robust frameworks to ensure biosimilars meet stringent quality,
safety and efficacy standards before market approval.
Global emergence of Biosimilars
marks a revolutionary shift in healthcare as it opens up treatment access for
millions of patients worldwide. Since their emergence in EU and other developed
markets over a decade ago, biosimilars are gradually gaining acceptance. Their
market share is steadily increasing across many therapy areas including
oncology, immunology and endocrinology.
Biosimilars approved by FDA
In the US, FDA approved the first biosimilar drug Zarxio (filgrastim-sndz) in
2015 under the Biologics Price Competition and Innovation Act (BPCI Act) of
2009. Since then, FDA has approved over 20 biosimilar products across important
therapeutic classes like oncology, immunology and endocrinology. Some of the notable
biosimilars approved by FDA include biosimilar versions of infliximab
(Inflectra, Renflexis), adalimumab (Hadlima, Cyltezo), bevacizumab (Mvasi,
Zirabev), trastuzumab (Ogivri) and others.
FDA approval means biosimilars can be automatically substituted for the RP at
the pharmacy counter in most US states following the same substitution rules as
generic prescription drugs. Post approval, FDA continues to monitor biosimilars
to ensure their safety, purity and potency remains equivalent to the reference
product through the product lifecycle. This provides additional assurance of
quality, safety and efficacy to physicians and patients.
Challenges in demonstrating biosimilarity
While the concept of biosimilars is not very different from generics, demonstrating
biosimilarity poses unique scientific and regulatory challenges compared to
small molecule generics. This is because biologics are complex molecules
derived from living cells and subtle changes during manufacturing can impact
clinical performance.
To gain regulatory approvals, biosimilar manufacturers need to conduct
extensive structural and functional characterization, animal toxicity studies
and clinical pharmacokinetic/pharmacodynamic studies to demonstrate no
clinically meaningful differences from the originator product. Due to
complexities involved in evaluating the intricate structures of biologics,
clinical endpoint similarity trials are difficult and in most cases not
required.
Regulators rely on a totality of evidence from analytical, nonclinical and
clinical data to scientifically justify a determination of biosimilarity.
Cutting-edge analytical techniques are used to fully characterize biosimilars
and compare them to the reference product. Despite regulatory complexities,
rigorous demonstration of biosimilarity provides clinicians and patients
confidence about biosimilars' quality, efficacy and safety profile.
Cost savings and increased access
Intense competition from multiple biosimilar approvals has begun to positively
impact the US healthcare system through significant cost savings. According to
a recent IQVIA report, biosimilars are estimated to save over $110 billion over
a ten year period with expanded adoption. For patients, biosimilars offer new
treatment choices and potential cost savings of up to 30-50% compared to the
originator biologics.
At the same time, biosimilars improve patient access by expanding the number of
treated patients through lower costs. FDA approval of more biosimilars will
benefit both public and private drug programs including Medicaid, Medicare as
well as employer-sponsored health plans. Experts project biosimilars may
increase US patient access to biologics by over 50% by 2025. With increasing
treatment options and lower costs, biosimilars have the potential to benefit
millions of US patients living with chronic illnesses like cancer and
autoimmune disorders.
The road ahead
Going forward, successful commercialization of approved biosimilars now hinges
on effective interchangeability and substitution policies as well as physician
acceptance and patient willingness to use lower-priced biosimilars. More
evidence from post marketing studies and real-world use will help increase
confidence and adoption rates among stakeholders.
FDA's recent approval of the first interchangeable biosimilar insulin glargine
(Semglee) is expected to pave way for additional interchangeable approvals for
biosimilars. Collectively, these policies and regulatory advances promise to
accelerate biosimilars' potential to reshape US healthcare by profoundly
reducing treatment costs and increasing access for patients in the coming
years. As both a scientific and commercial success story, biosimilars represent
one of the most promising opportunities to revolutionize healthcare sustainably.
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