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Losing Sight of What's Really at Stake in the Biosimilar Debate

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June 7, 2013 | 2,609 views | Post a comment

By Abby Bernstein

In 1988, I became extremely ill. I had many tests, saw many doctors and was given various medicines. Some caused allergic reactions. Through it all, I remained sick - and actually became worse.

Eventually, I was diagnosed with autoimmune hepatitis, which is a very rare disorder. Much of the information I read said I had about 10 years to live.

Making matters worse, I was soon diagnosed with another autoimmune disease, rheumatoid arthritis (RA). My treatment options for RA were severely limited because of my autoimmune hepatitis, as most of the RA drugs would filter through the liver and could initiate another attack.

The good news is that my doctor found a new "biologic" drug that effectively treated my RA without producing allergic reactions. With my autoimmune hepatitis thankfully in remission, I am now living a full and productive life thanks to this breakthrough. I know first-hand that the right medicine makes all the difference, especially for patients like me with multiple conditions.

Like all biologics, the medicine I take is very complex. On average, biologics contain molecules that are a thousand times larger than most regular medicines. That's because they are made from living organisms rather than chemical compounds. Because of this complexity, there's no real way to make a true generic version of a biologic.

However, a less expensive copy that's similar enough to treat the same disease can be manufactured. These drugs are called "biosimilars." I'm grateful for biosimilars, as I welcome anything that can lower the costs of my medicine.

But I believe a few common-sense safety measures need to be put in place to protect patient health when substitutions are made.

First, pharmacists should only be allowed to substitute a biosimilar if it has been approved by the Food and Drug Administration as interchangeable with the original biologic medicine. This means it has undergone rigorous testing, and it has been shown to be close enough to the original product that the benefits outweigh the risks.

Second, doctors must have the right to tell pharmacists that a prescribed biologic shouldn't be substituted with a biosimilar, because the biologics might be necessary for a patient with allergies or multiple conditions like me. This is the same process that's in place for generic drugs. It doesn't make sense to be any less cautious with a drug that's much more complex.

Third, and most important to me, pharmacies should be required to notify patients and their doctors when a biosimilar substitution is made. This simple step, along with the FDA's determination that the drug is interchangeable, would give me 100 percent confidence in what I'm about to put into my body.

If my doctor and I don't know I received a different drug, how can we both know to be mindful of any new reactions or changes?

Finally, doctors and pharmacists should keep records of these substitutions for a reasonable period of time. Biosimilars are a new class of drugs, and we don't fully understand them yet. In the event of an adverse reaction, these records can be used to quickly identify the manufacturer and address the issue immediately.

These are eminently reasonable precautions, and I don't believe they're too much to ask - especially when they may keep patients like me out of the hospital, or even save my life.

Over the past few months, some state legislatures have passed laws to allow for biosimilars to be substituted for biologics so long as these necessary safeguards are in place. (A version of this legislation in the Maryland General Assembly this year passed in the Senate but ran out of time in the House.)

Unfortunately, opponents of these measures have equated protecting patient safety with protecting drug company profits. I am very disheartened by this narrative. And I take issue with those policymakers, big pharmacy chains, benefit managers and insurers who have turned this into a debate about brand-name drugs versus generics. There is much more to this issue, and opponents of these measures are ignoring patient health.

Across the country, there are millions of patients like me - patients with complex autoimmune disorders or other conditions who need biologics. Many of us also have drug allergies or other conditions that put real limitations on the medicines we can take and the ways in which our body can tolerate medicines.

That's why we need laws that protect patient health. As more states consider biosimilar substitution, I urge policymakers to put patients first by including these necessary protections.

Abby Bernstein lives in Rockville, Maryland.
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