n 30 OCTOBER 2015 | PHARMACEUTICAL PROCESSING
nPIPELINE UPDATE nPHARMPRO.COM
Today’s pharmaceutical market is growing exponentially in potential. Not only has there been new brand-name and generic drugs pro- duced for a myriad of medical conditions, but
also botanicals with historical value emerging with the
potential to act as alternative treatments, along with the
emergence of biosimilars in the United States. All of these
changes only serve to engender a competitive environment, thriving on quantitative and qualitative productivity
and rapidity, among manufacturers.
BIOSIMILARS HIT THE U.S.
The month of September brought with it not only cool
autumn gusts and the return of school (at least for those
located in the American Northeast), but also the first
biosimilar to reach the U.S. Swiss drugmaker Novartis
AG launched Zarxio, a biosimilar version of Amgen Inc.'s
Neupogen. This drug works to boost white blood cell production in order to prevent infections in certain cancer patients as well as other patients.
“The pricing is about fifteen percent cheaper for Zarxio
than the Neupogen,” says Dr. Peter Calcott, Founder of
Calcott Consulting. “There’s a little bit of saving for Zarxio;
though, it’s nothing like the savings you see for generic
drugs. There, the savings are quite a bit more: probably
When addressing the key differences between biosimi-
lars and generics, Calcott said, “I think it gets down to two
elements. First is the pathway for approval for biosimilars
versus generics. For generics, you get onto the market eas-
ily. There are short human trials (which is about a week
to a 10-day assessment) to ensure that it behaves similar
to the proprietary drug. For biosimilars, you not only have
to make the drug, but prove that it works clinically. The
amount of work needed to get approval is considerable.
“The other factor is ease of manufacturing,” continues
Not only is there are considerably higher financial investment
to get a biosimilar onto the market, compared to a generic drug,
but there is also a substantial amount of research involved.
BIOSIMILARS: THEN AND NOW
Biosimilars have been a part of the pharmaceutical industry in Europe since 2006. Currently, longer patent durations are preventing the creation of copies of many top
biologic drugs for a few more years in the United States.
In addition, the FDA only recently finalized the regulations
governing approval of biosimilars. Even though there is
only one biosimilar on the market in the U.S., this is a big
trend for manufacturers.
“I think what you are going to see is the ‘block bust-
ers’—where there is a real need for the drugs—is where
the next biosimilars will be,” says Calcott, when discussing
the future of biosimilars. “Look at where sales are and that
will be point you in the
panies that currently
make their own biologic
drugs, such as Novartis,
Pfizer Inc. and Merck
& Co., are said to be
of rival companies' top
When asked how
manufacturers can prepare for the emergence
of biosimilars, Calcott
says, “I think technology will help them, and
it will also help manufacturers of proprietary
drugs. We are moving
towards single-use in biological manufacturing.
The cleaning and preparing stainless steel
tanks for the next batch
requires extensive use
The Emergence of Biosimilars
and Botanical Alternatives
n By Meg Snyder, Editor, Pharmaceutical Processing