The Senate Health Committee recently cleared a bill that would
allow generic drug manufacturers to enter the multi-billion dollar
biological-drug market. The measure, which next heads to the full
Senate for a vote, would clear the way for these drugs by requiring
the Food and Drug Administration to create an approval process for
follow-on biologics.
Supporters of the legislation assert that its passage would save
consumers billions of dollars and provide safe, affordable access
to biologic drugs. These claims are severely overstated, however,
and worrying safety issues are inherent in the bill’s
provisions.
Most drugs are formed from simple chemical compounds with
structures that are easily duplicated. Generic copies are therefore
exactly the same as their brand-name counterparts and are cheap to
produce. But there’s no such thing as a “generic” biologic, because
they’re much larger — and much more complicated — than simple
chemical compounds.
Biologic production involves the use of life forms such as yeast
and bacteria. Because of the diverse composition and metabolism of
the producers, each final biologic product is a unique,
heterogeneous mix of materials.
Consequently, safety review is very expensive — and inexact
without extensive clinical testing. Whereas common generics like
penicillin only require 50-60 safety and quality manufacturing
tests, biologics require at least four times that number. In fact,
the technology is not yet available to map out the exact nature of
one large biologic versus another.
Therefore, the cost-savings for follow-on biologics are limited.
In the European Union and Australia, which both have regulatory
systems for follow-on biologics, savings amount to roughly 10
percent off brand-name prices.
More important, the EU and Australia have had to devote a great
deal of attention to safety. Unlike chemical generics, all
biologics must address the reaction of the body’s immune system to
the drug. Failure to take this factor into account can result in
devastating side effects.
Seven years ago in Europe, for example, a fully-tested biologic
which aids in the production of red blood cells was found to have
induced patients to experience “pure red cell aplasia,” whereby
their bodies could not make red cells. Many died.
Even after more than seven years of intense investigation, it is
still unclear how the reaction happened. In response, the European
Union created a rigorous regulatory system to review follow-on
biologics.
Yet the follow-on biologics proposal that has cleared the Health
Committee ignores these lessons. As written, it would allow the
approval of follow-ons without the assessments required in the
European Union, which include one year of testing, risk-management
plans, and comparative clinical trials.
Further, the proposal legally allows molecular differences in
follow-on products, even though such differences are the very ones
scientifically shown to be associated with dangerous reactions.
A better way to guarantee safety — while still improving access
— would be to test biologics as the Europeans have done. To help
the underserved, Congress could also mandate that both branded and
follow-on biologic firms participate in a low-cost or no-cost drug
program for the needy.
With the measure makes its way to a full Senate vote, let’s hope
the nation’s lawmakers put patient safety first in the debate over
follow-on biologics.
