Policies & Legislation
The US government could save more money by increasing the use of cheaper generic drugs rather than hiking rebates paid by manufacturers, an industry executive said on 17 September 2009.
Roche has agreed not to oppose Amgen's request for a limited exclusion order that would block the import of Roche's anaemia drug Mircera into the US Amgen filed a motion recently with the US International Trade Commission (ITC) asking for a summary determination that Roche had violated a section of the Smoot-Hawley Tariff Act by importing the pegylated erythropoietin product Mircera (methoxy polyethylene glycol-epoetin beta), which Amgen claims infringes its patents.
The EU has assured India that it will take steps to resolve the issue related to the recent cases of life-saving generic or off-patent medicines exported from India to other countries being seized at European ports, but would prefer not to do so through a legal battle at the World Trade Organization (WTO).
With an EU regulatory framework in place to address the safety of biosimilars – also known as follow-on biologics (FOBs) – the opportunity represented by these products has been proven, and it is growing, as reported by Cynthia Challener in ICIS Chemical Business.
On 18 June 2009, WHO published a Prequalification Update, informing that a guideline on submission of documentation for prequalification of multisource (generic) has been completed and that Finished Pharmaceutical Products (FPPs) will be approved by Stringent Regulatory Authorities (SRAs). It states that WHO recognises the scientific evaluation of multisource (generic) products by regulatory authorities, which apply similarly stringent standards for quality, safety and efficacy as those recommended by WHO.
Mr Randall Stafford of the Stanford Prevention Research Center and Mr Caleb Alexander of the University of Chicago, USA have published several challenges that must be met if comparative-effectiveness research (CER) is to be useful in significantly improving the quality and affordability of US health care. In the 17 June 2009 issue of the Journal of the American Medical Association they write, “Researchers, policy makers, insurers, and other stakeholders have voiced enthusiasm about the value of CER that rigorously evaluates two or more drugs or devices. The most recent boost for these efforts has been the US congressional financial stimulus package that contains provisions for US$1.1 billion (Euros 787.4 million) to be devoted to this effort. The appeal of CER is undeniable. If there is one issue that stakeholders agree about, it is that increasing healthcare costs are ultimately unsustainable and society needs more value for its money. However, it is not clear whether CER, as it is commonly framed, has a comparative advantage when it comes to improving the US healthcare system. If CER is to succeed, future initiatives will need to generate data prior to the widespread adoption of a drug or device.”
In the US, the outstanding issue surrounding the biosimilars debate remains the exclusivity period before competitors can come on the US market – and the US is no closer to a resolution following the 10 June 2009 report by the Federal Trade Commission (FTC), Emerging Health Care Issues: Follow-on Biologic Drug Competition.
In Europe first EU generic entrants should be given a period of market exclusivity, Teva Europe President and CEO, Dr Gerard Van Odijk, claimed at the World Generic Medicines Congress Europe 2009 held in London, UK, in February. He said that once a product’s patent expired “everyone jumps on the bandwagon. What we need is an alternative way to continue the appetite to take risks in Europe.”
Biosimilars present a new set of challenges for regulatory authorities compared with conventional small-molecule generics, for which the demonstration of pharmacokinetic similarity to the reference product is sufficient.