Industry and consumer groups are urging action against what they say is lobbying by biotechnology companies of US state legislators aimed at restricting access to biosimilar versions of branded biologic drugs.
The protests follow a report in the New York Times that Amgen and Genentech are proposing bills that would restrict the ability of pharmacists to substitute generic versions of brand-name biologics which, it says, now cost patients or their insurers "tens or even hundreds of thousands of dollars a year." The Virginia House of Delegates approved such a bill last month, by a 91-6 vote, and similar legislation has been introduced in at least eight states since the new legislative sessions began in January, with others pending, it says.
The Pharmaceutical Care Management Association ((PCMA), which represents pharmacy benefit managers (PBMs), has condemned the companies' actions, saying they are designed to pre-empt moves now underway at the Food and Drug Administration (FDA) to create a pathway for approval of biosmilars by "creating a flurry of state laws that will conflict with the FDA's forthcoming national standards."
"Creating a patchwork of duelling state and federal rules would make it harder for pharmacists to know when they can dispense a biosimilar. That would raise costs for patients and their employers, who typically cover two-thirds of prescription drug benefit costs," says the Association.
And industry group the Generic Pharmaceutical Association (GPhA) describes the efforts as "a pre-emptive strike by Amgen and Genentech designed to choke the flow of safe and affordable life-saving biologic medicines to patients" - even before they have received FDA approval.
"This is unfortunate because it puts profits ahead of the patients who need these treatments but many times cannot get them because of their prohibitive high cost," says the GPhA. "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," it adds.
Amgen has said that state efforts to create substitution rules for interchangeable biologics will help accelerate successful implementation of the biosimilars pathway, and that it is helping to educate stake policymakers on the issues that need to be considered, to ensure that physicians, patients and pharmacists share important information about biologic substitution.
"Amgen endorses state policies that would put patients first and, in doing so, increase confidence in the biosimilar pathway. It is important to have consistent policies in place at the federal and state level," said Scott Foraker, vice president and general manager of biosimilars at the company.
Nevertheless, seniors' group the Association of Mature Americans (AMAC) is calling on its members, their families and friends to urge their local and federal lawmakers to act to protect access to generics.
"Biosimilar pharmaceuticals may be a special class of drugs but they represent a potential opening shot in a new war against generics," AMA president Dan Weber warns.
"The big drug companies are targeting generic versions of such important brands as Humira [adalimumab] and Enbrel [etanercept], which treat rheumatoid arthritis, and Herceptin [trastuzumab], Avastin [bevacizumab] and Rituxan [rituximab], which target cancer. If they succeed, it could put treatment out of the reach of many seniors, particularly those on fixed incomes," he says.
And in an interview on the Fox Business News channel, AMAC spokesman Andrew Mangione called for leadership on the issue from both the Administration and the FDA.
"We're in uncharted territory," said Mr Mangione. "The federal government has to work in concert with drug organisations to make sure they come up with a fair and equitable solution, but they should not do it on the backs of senior citizens."
- The Pharmaceutical Research and Manufacturers of America (PhRMA) has commented that, as states consider legislation specific to biosmilars substitution, “we believe it essential that patient safety be the utmost priority." And, in implementing the biosimilars pathway, FDA "must ensure that patients have access to safe and effective bisiomilars, which will require clinical data to demonstrate biosimilarity," it adds.
However, "given the limits of current scientific knowledge and for reasons of patient safety, we cannot envision a biosimilar product or class of products for which comparative clinical studies would be unnecessary for approval," says PhRMA.