How to Address Unique Challenges
with Generics and Process Scale-Up
Biosimilar manufacturers are creating generic versions of
biologics and beginning the process of filing for approval once
they come off patent.
By Eric Resnick, Vice President and Chief Technology Officer, West Pharmaceutical Services, Inc.
Each year, generics manufacturers offer affordable treatment options for patients and provide needed medication when critical drugs are in short supply. For these
manufacturers, the race to be the first to file their
drug for FDA approval after the original’s patent
expires is critical.
The importance of filing first is complicated by
the fact that these drugs, biologics and biosimilars,
are increasingly being self-administered by patients
via drug delivery systems. Unlike biologics
manufacturers that often fold the development of
a customized delivery technology into the plan,
biosimilar drug makers often rely on “
off-the-shelf” systems that are not made specifically for
To remain competitive, it is important that
generics manufacturers have a plan that will allow
them to move quickly to find a way to package
and deliver their product. This can be particularly
challenging for generics manufacturers given their
smaller operating budgets, tight time constraints,
and the need to adhere to industry requirements
and regulatory restrictions.
In this climate, forging strong partnerships
with a drug delivery system manufacturer who
is nimble, responsive, and knowledgeable about
global regulations can help the drug manufacturer
be first to file.
The Generic and Biologic Boom
The generic drug market in the United States is
quickly expanding with no signs of slowing down.
According to a 2016 study, the global generics
market is expected to experience a 10.53 percent
compounded annual growth rate (CAGR) from
2016-2020, with the value of drugs coming off
expired patents equaling $150 billion by 2020(1).
IMS Health found that more than 90 percent of
dispensed medicine will be generic by 2020( 2).
Biologics have proven to be some of the more
promising drugs in the pharmaceutical industry
pipeline. Over the past several years, there has been
a steady rise in biologic drugs used to treat chronic
conditions because of their potential to offer
patients better long-term outcomes and fewer side
effects than traditional, chemical-based therapies.
Biosimilar manufacturers are creating generic
versions of biologics and beginning the process of
filing for approval once they come off patent. As
a result, biosimilars are expected to be a driving
force in further expanding the generic drug market
in coming years.
Walking a Fine Line and Navigating
Because of their smaller operating budgets,
generics manufacturers are looking to leverage
existing delivery system components and
combination products. This can be challenging
given that in many cases, the original combination
product for an injectable biologic drug is custom-made and there may be exclusivity with a delivery
Further complicating matters is that the generic
or biosimilar product cannot depart too much from
the predicate drug delivery combination product, or
it risks facing regulatory roadblocks upon filing.
To combat this, a generic product can be
formulated to have a release mechanism that is
different from the reference product as long as
the generic product is pharmaceutically equivalent
and bioequivalent to the reference product.
Quality by Design (QbD) can be used by generic