What are biosimilars?
Biosimilar drugs and reference
drugs are made from living organisms but they may be made in different ways and
of slightly different substances. To be called a biosimilar drug, a biological
drug must be shown to be as safe as, work as well as, and work in the same way
as its reference drug.
Expansion in rates of diabetes and
immune system sicknesses drives the development of the worldwide biosimilars
market. Additionally, good government arrangements and new item dispatches in
the biosimilars business have enhanced the development yet more. Also, a few
development possibilities in the created as well as creating economies have
been gainful for the vital participants in the business.
According to the report,
the global biosimilars market was estimated at $15.9 billion in 2021, and is
anticipated to hit $143.6 billion by 2031.
After 20 years and $200 billion in revenue, Humira — an injectable treatment for rheumatoid arthritis and several other autoimmune conditions — has lost its monopoly. Early Tuesday morning, California-based biotech firm Amgen released Amjevita, the first close copy of the best selling drug of all time. At least seven more Humira copycats, known as biosimilars, are expected to debut later this year.
"It's about
time!" said Sameer Awsare with a laugh and a smile. Awsare,
associate executive director for the Permanente Medical Group, advises national
insurer Kaiser Permanente on its prescription drug policies. Other groups
representing insurers, patients or employers are also eager for these
biosimilars to usher in more competition — in hopes that will enable them to
slash their spending on the popular treatment.
But among industry
watchers, the prevailing sentiment is uncertainty over whether competition
alone will bring the price down.
"I am pretty
anxious," said Marta Wosińska, an economist and fellow at the
Brookings Institution.
Humira losing its
monopoly creates the biggest test the fledgling U.S. biosimilars market has
ever faced. It's a market critical to containing drug costs in the U.S., which
relies primarily on competition rather than regulation to rein in spending.
A golden opportunity for a
beleaguered biosimilars market
Biosimilars are
highly similar versions of a rapidly growing class
of drugs called biologics, a broad range of treatments or
preventatives that include immunotherapies, insulins and certain vaccines made
from living cells.
While biologics are driving many of medicine's most exciting new advances — shrinking tumors, controlling diabetes, even delaying dementia — they are also consuming more of our money. Biologics account for nearly half of U.S. drug spending despite comprising less than 3% of prescriptions.
How biosimilars are
different from generics
Unlike generics, biosimilars face a unique set of regulatory, manufacturing and business challenges. Conventional drugs can be replicated like a recipe in a cookbook using chemical processes. In contrast, because biologic drugs are grown in living cells, they are harder to mimic, making biosimilars more difficult and expensive to manufacture. Experts debate whether those unique challenges have doomed this market or if biosimilars simply need more time to establish themselves.
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