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Marylanders deserve low-cost biotech, high safety standards

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Published on: Tuesday, April 02, 2013

By Virginia Ladd

Judging from his latest budget proposal, Gov. Martin O’Malley intends to make health care a priority in the coming year. His plan for fiscal 2014 would increase healthcare spending by more than $397 million in hopes of expanding access to quality medical care across the Old Line State.

This is undoubtedly good news. But as state leaders work to broaden access to care, they must be sure not to intrude on the doctor-patient relationship or endanger patient safety. Nowhere is that principle more important than in the burgeoning field of sophisticated pharmaceuticals known as “biologics.”

Biologics are complex medicines made from living material. They’ve proven a boon in the fight against some of the most debilitating diseases, including arthritis, lupus and several autoimmune disorders.

Biologics are also expensive. One biologic treatment for multiple sclerosis, for instance, costs as much as $20,000 a year.

If state lawmakers are to expand access to care as they hope to, they’ll have to find ways to make innovative treatments affordable.

Generic drugs have helped bring down the cost of conventional, small-molecule drugs. Most patients and doctors don’t think twice about substituting less expensive generic atorvastatin calcium for Lipitor, for instance.

Unfortunately, the same strategy will not work for biologics.

Biologics contain thousands of atoms — many times more than a traditional small-molecule drug. And because they’re manufactured using living organisms and natural processes, it’s impossible to create an exact copy of a biologic.

So there’s no such thing as a “generic biologic.” But scientists can create “biosimilars” — rough copies of biologics. These drugs have the potential to offer the same therapeutic effects as biologics at far lower prices.

Lawmakers have yet to determine the process by which these lower-cost alternatives can be substituted for biologics. Senate Bill 781 represents a common-sense, balanced approach for doing so.

Biosimilars are a relatively new development in medical technology. And since they’re not molecule-for-molecule copies of brand-name biologics, it’s difficult to know for sure how they’ll interact with each patient’s immune system.

Lawmakers must therefore implement a set of simple rules to ensure that biosimilars are substituted with care.

For starters, physicians must be aware of any substitutions of biosimilars for biologics by pharmacists. Pharmacists should only be free to replace a brand-name biologic with a biosimilar if the Food and Drug Administration has ruled that the two are interchangeable. This provision is critical to protect the relationship between the prescriber and the patient, especially when managing multiple medications that target complex chronic diseases.

Patients should also be told of the substitution when the biosimilar is substituted. The prescriber, meanwhile, should be notified within five days. This common-sense approach ensures that doctors and patients can work together with the pharmacist to ensure the highest level of individualized patient care.

Finally, records of biosimilar substitutions should be maintained for at least two years. This will help medical professionals garner a deeper understanding of the effects of these substances — and inform medical research into their long-term effects.

By putting these safeguards in place, lawmakers can make sure that there is a clear pathway for biosimilar substitution here in Maryland. At the moment, no such pathway exists.

State lawmakers will soon have the chance to expand access to these medicines to the thousands of patients who need them. Senate Bill 781 is their opportunity to do that in a balanced manner that both increases access and ensures patient safety.

Virginia Ladd is president of the American Autoimmune Related Diseases Association.

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