WASHINGTON, D.C.—With billions of dollars on the line aslucrative patents expire in 2016, and with the impending federal healthcare lawjust around the corner, pharmaceutical and biotech giants are lobbyinglegislators to limit generics and biosimilars.
Currently, 13 state legislatures have bills pending to limitpatient 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, andstate laws should require consent from the doctor and patient for substitution,pharmaceutical and biologic companies are taking their arguments to theirlegislators. Of particular concern to them is a provision in the AffordableCare Act allowing biosimilars to be substituted by pharmacies without theconsent of doctors and patients, just like generic drugs approved by the U.S.Food and Drug Administration (FDA). Although opponents of this view argue thatthis provision will make healthcare more affordable for consumers, pharma and biotechcompanies counter that it may cost the U.S. pharmaceutical manufacturingindustry the incentive to create new treatments for diseases.
In particular, Amgen and Genentech caught the eye of the NewYork Times, which last month reported thatboth companies are proposing bills to restrict the ability of pharmacists tosubstitute generic drugs for their brand-name products. Under a 1984 lawgoverning generic substitution, generic medications must be chemicallyidentical to their brand-name counterparts in order to be substituted at thepharmacy.
While drug companies argue that biosimilars are not similarenough, the General Pharmaceutical Association says biosimilars are indeedsafe. Ralph G. Neas, president and CEO of the association, contended in a statementto association members that a "preemptive strike by Amgen and Genentech isdesigned to choke the flow of safe and affordable life-saving biologicmedicines to patients even before these products have been approved by theFDA."
"This is unfortunate, because it puts profits ahead of thepatients who need these treatments, but many times cannot get them because oftheir 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 moreaffordable therapies to patients, but they also will dramatically decrease themuch-needed cost savings that biosimilars will provide," Neas added. "At a timewhen legislators are desperately seeking ways to keep their state fiscallysound, these bills will encourage needless and wasteful spending on name-brandtherapies, even after FDA-approved, lower-cost biosimilar products becomeavailable.
"While in the guise of supporting biosimilar efforts, Amgenand Genentech are making every effort to limit consumer and patient access tosafe and effective biosimilars in the future," he continued. "The push forthese new measures has nothing to do with safety and everything to do withAmgen and Genentech, two biotech Goliaths, trying to thwart competition. Withnearly $11 million spent in 2011 alone on costly biologic medicines in theirstate Medicaid program, Mississippi state legislators know that creatingbarriers between patients and newer, low-cost versions of these therapies isnot right for their state. If passed, these measures would be harmful to theirconstituents and wreak havoc on their state budget."
While the pharmaceutical industry and states await decisionsby the FDA regarding which drugs can be prescribed interchangeably, Amgen andGenentech are engaged in a documented campaign to slow access to these safe andaffordable biosimilar medicines, Neas alleged.
"That makes it extremely difficult to tell if a copy of abiological drug is identical to the original," Neas stated. "Even slightchanges 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 developingboth original biologics and biosimilars, and that its support of state pharmacyacts is based on the company's belief that enhanced safety monitoring andtransparency of substituted biologics is in the interest of patient safety.
Amgen, however, said it also believes that "states' effortsto create substitution rules that strengthen communication between physician,pharmacist and patient will help accelerate the successful implementation ofthe U.S. biosimilars pathway. Safe substitution of biologics and biosimilarsrequires not just that medicines are safe, but also that the doctor is notifiedabout the actual product dispensed when different from that prescribed, and canmaintain the patient record accordingly."