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Taking it to the states
WASHINGTON, D.C.óWith billions of dollars on the line as lucrative patents expire in 2016, and with the impending federal healthcare law just around the corner, pharmaceutical and biotech giants are lobbying legislators to limit generics and biosimilars.
Currently, 13 state legislatures have bills pending to limit patient access to cheaper drug knock-offs: Arizona, Arkansas, Colorado, Florida, Indiana, Maryland, Massachusetts, North Dakota, Oregon, Pennsylvania, Texas, Virginia and Washington.
Arguing that substituting biosimilars can be unsafe, and state laws should require consent from the doctor and patient for substitution, pharmaceutical and biologic companies are taking their arguments to their legislators. Of particular concern to them is a provision in the Affordable Care Act allowing biosimilars to be substituted by pharmacies without the consent of doctors and patients, just like generic drugs approved by the U.S. Food and Drug Administration (FDA). Although opponents of this view argue that this provision will make healthcare more affordable for consumers, pharma and biotech companies counter that it may cost the U.S. pharmaceutical manufacturing industry the incentive to create new treatments for diseases.
In particular, Amgen and Genentech caught the eye of the New York Times, which last month reported that both companies are proposing bills to restrict the ability of pharmacists to substitute generic drugs for their brand-name products. Under a 1984 law governing generic substitution, generic medications must be chemically identical to their brand-name counterparts in order to be substituted at the pharmacy.
While drug companies argue that biosimilars are not similar enough, the General Pharmaceutical Association says biosimilars are indeed safe. Ralph G. Neas, president and CEO of the association, contended in a statement to association members that a "preemptive strike by Amgen and Genentech is designed to choke the flow of safe and affordable life-saving biologic medicines to patients even before these products have been approved by the FDA."
"This is unfortunate, because it puts profits ahead of the patients who need these treatments, but many times cannot get them because of their prohibitively high cost," Neas stated.
The efforts highlighted in the Times story "are doubly worrying for state legislators, because not only will they slow availability of safe, effective and more affordable therapies to patients, but they also will dramatically decrease the much-needed cost savings that biosimilars will provide," Neas added. "At a time when legislators are desperately seeking ways to keep their state fiscally sound, these bills will encourage needless and wasteful spending on name-brand therapies, even after FDA-approved, lower-cost biosimilar products become available.
"While in the guise of supporting biosimilar efforts, Amgen and Genentech are making every effort to limit consumer and patient access to safe and effective biosimilars in the future," he continued. "The push for these new measures has nothing to do with safety and everything to do with Amgen and Genentech, two biotech Goliaths, trying to thwart competition. With nearly $11 million spent in 2011 alone on costly biologic medicines in their state Medicaid program, Mississippi state legislators know that creating barriers between patients and newer, low-cost versions of these therapies is not right for their state. If passed, these measures would be harmful to their constituents and wreak havoc on their state budget."
While the pharmaceutical industry and states await decisions by the FDA regarding which drugs can be prescribed interchangeably, Amgen and Genentech are engaged in a documented campaign to slow access to these safe and affordable biosimilar medicines, Neas alleged.
"That makes it extremely difficult to tell if a copy of a biological drug is identical to the original," Neas stated. "Even slight changes in the cells that make the proteins can change the drug's properties."
In response, Amgen stated that reports in the Times failed to mention that the company is developing both original biologics and biosimilars, and that its support of state pharmacy acts is based on the company's belief that enhanced safety monitoring and transparency of substituted biologics is in the interest of patient safety.
Amgen, however, said it also believes that "states' efforts to create substitution rules that strengthen communication between physician, pharmacist and patient will help accelerate the successful implementation of the U.S. biosimilars pathway. Safe substitution of biologics and biosimilars requires not just that medicines are safe, but also that the doctor is notified about the actual product dispensed when different from that prescribed, and can maintain the patient record accordingly."