If you want an iPhone 4 but
can’t afford it, it’s easy to find a similar Smartphone for less money.
The same is true when it comes to laptop computers. Magazines and blogs
are full of helpful tips for today’s discerning consumers to find just the
right laptop, the right phone, and even the right speakers that function
similarly to high-end models.
Some people would tell you
it’s the same with prescription drugs. We do know that generic drugs have
the same chemical composition as the originals. But that is far from true
when it comes to a new class of drugs known as biologics.
Biologics are complex,
large-molecule drugs. More importantly, they are manufactured using
processes involving living cells. They may have hundreds of compounds of
sugars, nucleic acids, proteins, or combinations in three-dimensional
molecules. But unlike gadgets, biologics’ imitator versions, known as
"biosimilars" can never be exactly the same as the innovator model.
Because creating biosimilar
drugs isn’t simply a matter of matching a chemical compound, the Food and Drug
Administration (FDA) needs to take special precautions in determining how to
test, approve and track biologics and their follow-on editions. In fact,
to date, no biosimilars have been approved for use in the U.S. But we may
in the near future, and it is important that patient safety be the overriding
principle as they are developed, approved, and prescribed. The European
Union is several years ahead in establishing a regulatory system for
biosimilars, and we can learn a lot from them.
Remember, these are not
simply clones of a chemical compound. Biosimilars may be similar, but
they are not the same as the original biologic, so we can’t accept shortcuts when
it comes to testing the new drugs. To that end, "similar" versions should
not be allowed to skip clinical trials, for example, because we cannot just
assume that they will be close enough to the original to have the same effect
in patients.
Doctors and patients must
know exactly what they are getting through clear labeling and unique drug
names. We need a whole new system to trace the exact biologic or
biosimilar separately so that any adverse events can be reported accurately and
traced to the specific drug or batch of drugs.
Because biologic drugs may
someday be based on a patient’s own DNA, it becomes even more important that
this class of drugs have specific regulations and oversights than those of
ordinary chemical drugs.
Biologic drugs promise
important breakthroughs in the treatment of diseases. For instance, the
biologic therapy Gleevec revolutionized
medicine by converting a fatal cancer into a manageable chronic condition.
Dubbed the "magic bullet" to cure cancer, Gleevec was featured on the cover of TIME
magazine in May 2001, the same month it was approved by the FDA.
Biologics are also used to manage other debilitating conditions including
arthritis, renal failure and HIV/AIDS. And by 2014,
it is projected that six out of the 10 top-selling drugs in the U.S. will be
biologics, some of which may face biosimilar entry.
If we commit ourselves to
making patient safety the top priority, we will develop a regulatory structure
that puts every drug-whether a biologic or a biosimilar-through comprehensive
testing to ensure they actually do what they claim to do without introducing
new and unexpected risks or side effects.
Similar may be good enough
when it comes to buying gadgets, but it’s not good enough when it comes to our
health.