Despite how far we have come, there is still ample room to grow.
By Meg La Torre-Snyder, Editor
Biosimilars have come a long way since their initial entry in the U.S. on March 6, 2015.
However, with a number of
unanswered questions (such
as pricing, availability, and
interchangeability) and a
lack of understanding in the
marketplace, biosimilars still
have so much opportunity to
grow in prominence in the U.S.
What is a Biosimilar?
According to the FDA,
biosimilars are a type of
biological product that are “highly
similar to an already FDA-
approved biological product.” An
interchangeable biological product, on the other
hand, “in addition to meeting the biosimilarity
standard, is expected to produce the same clinical
result as the reference product in any given patient.”
“Biosimilars are specialty drugs that are made
out of biologics—or out of living organisms,” said
Pankaj Mohan, CEO of Oncobiologics. “The way I
look at it is these are very expensive, critical drugs,
and its availability and affordability depends on
how the biosimilar industry shapes up.”
Biosimilars are a way to reduce the cost of
biologic drugs so that they are more affordable and
widely available, Mohan said.
Only now entering the U.S. market, biosimilars
have been introduced in Europe for some time.
Although there is a significant market for
biosimilars in Europe, the U.S. is considered to be
the largest market for biosimilars.
“There is a significant amount of political and
social pressure that’s been driving the lower cost of
healthcare in the U.S.,” Mohan explained.
Many consumers have voiced complaints
regarding the cost of biosimilars—specifically that
they do not have the same discount as generics.
“Biosimilars is a totally different category than
small molecule generics,” said Mohan. “It’s a big
technical hurdle to develop biosimilars and very
complex to manufacture, and it takes a significant
amount of investment to get regulatory approval.
One has to do complete PK and at the same time
has to do the most expensive part which is doing
the phase 3 trials (which is not required for small
“The cost of developing a biosimilar is high. . . .
It’s highly specialized, and with the investment that
it needs, it falls in a totally different category than
small molecule generics.”
In addition, there is only a small group of
players who are working within the biosimilars
space—from small, niche companies, such as
Oncobiologics, to the biotech and pharmaceutical
giants, such as Amgen and Pfizer.
Compared to the discount that small molecule
generics can expect—which can be as much as 90
percent—typical discounts for biosimilars range
between 20 and 40 percent.
Furthermore, only a small percent ( 5-8 percent)
of the U.S. population takes specialty drugs, such
A manufacturing engineer works with a 2000 L single-use bioreactor in the upstream
production suite of Oncobiologics’ 20,000 sq. ft. manufacturing facility.