A US Senate panel has voted unanimously in favour of giving the country’s healthcare regulator the power to approve follow-on biologic drugs, but generic companies have already objected to a clause which states that a copycat version of a biotechnology drug cannot be given the go-ahead until the original has been on the market for 12 years.
The US Senate Health, Education, Labor and Pensions Committee has passed The Biologics Price Competition and Innovation Act which will allow the US Food and Drug Administration to approve biogenerics of the types of treatments made by biotechnology firms such as Amgen and Genentech. The bill was sponsored by Democrat Senators Edward Kennedy, Hillary Clinton and Charles Schumer, plus Republicans Orrin Hatch and Mike Enzi.
The committee says that the legislation uses a procedure “designed to help resolve patents in an expedited way, and strong but responsible incentives to encourage innovation and the development of new therapies”. Its key elements include a requirement for a generics company to demonstrate that there are no clinically meaningful differences in safety, purity and potency between its product and the original, through “analytical data, animal testing and one or more clinical studies,” unless the FDA deems it unnecessary.
The Act also provides “incentives for the development of both new life-saving biological products and interchangeable biosimilar products,” notably 12 years of data exclusivity for the brand company and one year of exclusivity for the biosimilar. The legislation also includes “a multi-step process to identify and resolve patents that the biogeneric may infringe”.
Sen Kennedy said the bill reflects “a balanced approach that enables patients to have safe, effective and affordable biological drugs, while preserving the incentives that have brought these life-saving advances to the American public”. Sen Hatch added that "we've achieved a good balance. We give incentives to continue biological development. We allow generic companies to do what they do best – bring low-cost versions to the market. And we ensure that patients and providers not only have access to low-cost biologics but that they're also safe."
Sen Clinton claimed that the Act “has real life, real world consequences” because “as soon as we enact this bill, there are medications for hepatitis C, multiple sclerosis, cancer and diabetes that will be available for generic versions that will be more affordable for many more people”. Sen Schumer concluded by arguing that “giving the FDA authority to approve follow-on biologics is the first step to introducing competition into the market".
12 years is ‘arbitrary and excessive’
The response from generics companies, however, was not exactly wholehearted. The USA’s Generic Pharmaceutical Association president Kathleen Jaeger said that the organisation applauds “the extraordinary efforts of the Committee to craft a long-overdue pathway for safe and effective biogenerics”, but 12 years of marketing exclusivity for branded products is an “arbitrary and excessive period of time” that is not only “unprecedented and unwarranted, but more importantly, would unjustifiably delay access to affordable competition and choice for consumers and businesses alike”.
She also said that "another flawed provision” would permit brand companies to make minor changes to their product and receive an additional 12 years of exclusivity, “in effect maintaining their monopolies in perpetuity”. This ‘evergreening’ process “would essentially prevent safe and affordable life saving biogenerics from ever reaching patients,” she concluded.
Ms Jaeger’s reservations were repeated by the world’s biggest generics drugmaker Teva. Although it described the Act as “a significant step forward,” the firm added that it looks forward to "continuing to work with the bill's sponsors and other policymakers to rectify concerns" about the 12-year issue and “fulfil the promise of true competition and access to affordable healthcare that this bill should offer”.
As for the branded drug manufacturers, they too seem to have some qualms. The USA’s Biotechnology Industry Organization praised the Act but claimed that it also includes “several provisions that cause concern for biotechnology pioneers, particularly regarding insufficient protection for patient safety and the patient-doctor relationship”.
BIO chief executive Jim Greenwood noted that most firms “are in very nascent stages of development and need financial support in the form of large amounts of public and private capital investment. Data exclusivity helps provide needed predictability for the investments required for the more than a decade typically necessary to produce a single innovative biologic treatment”.
Biotech firms want 14 years’ exclusivity
However, he added, “we continue to believe that a strong case has been made that 14 years of data exclusivity is the needed period required to strike the right balance between providing incentives for innovation and follow-on product entry”, which would put biotechnology on a par with the patent term protection provided for small molecule pharmaceuticals under the Hatch-Waxman Act.
The debate clearly has a long way to run and it looks likely to be a heated one as the bill now moves to the floor of the Senate.