The Datamonitor report, Biosimilars: Regulatory Issues, Europe continues to make strides while the US lags behind, found the US is tied up in red tape as the country continues to waddle through the legal mud with the likelihood that no key law will be in place by Christmas. Already five biosimilars - biogenerics, follow-on proteins or follow-on biologics as they are known in the US - have been approved in the EU following the 2004 Directive adopted by the European Commission, which laid out the legal ground for the approval of generic versions of biologic drugs. Meanwhile, the US has proposed three different bills this year alone to formulate a statutory pathway for approval, but these have been hindered by political issues and the uneasy relationship between innovators and generic companies, the report said. "In the US, political issues and the tug-of-war between innovators and generic companies have delayed the formulation of legislation regarding regulatory approval of biosimilars, and the FDA has been reluctant to issue any guidance," Datamonitor senior pharmaceutical analyst and report author Dr Tijana Ignjatovic said. "However, increasing expenditure on biologics - both by Medicare and private insurers - has spurred lawmakers into action. In the first half of 2007, three different bills have been proposed formulating a statutory pathway for the approval of biosimilars of biologics approved under the Biologic License Application (BLA)." In February, the Access to Life-Saving Medicine Act was introduced into Congress, and then in April Congress saw the Patent Protection and Innovative Biologic Medicine Act introduced. Neither bill made any progress, with the former being pro-biosimilar and the latter being pro-innovator. In June, a compromise was reached with the introduction of the Biologics Price Competition and Innovation Act. This bill was designed to balance the interests of the public with those of the biosimilar and innovative pharmaceutical industry, Ignjatovic said. "It proposes 12 years of market exclusivity for the patent holders but also one year of exclusivity to the first biosimilar to be approved as interchangeable with the reference product," she said. "Clearly this legislation is much more detailed than the EC Directive, as it addresses issues such as market exclusivity and patent litigation. However, it proposes that liberty is given to the FDA as to the requirements for approval of biosimilars, and the FDA is expected to be led by EMEA's (European Medicine Evaluation Agency) approach." The bill was hoped to be passed as part of the Prescription Drug User Fee Act (PDUFA), which was reauthorized at the end of last month, but failed to be attached. As a result, no law was passed on biosimilars. That said, the Datamonitor report claimed the bill was controversial and would have "several important ramifications on the potential for commercial success of biosimilars" should it be passed. While the one-year exclusivity on the first biosimilar could potentially make the market quite lucrative, the bill could also lead to a highly litigious environment, and could deter smaller players from entering the market, the report said. "Furthermore, there is a lack of clarity on issues such as naming of biosimilars - a contentious issue in Europe - and the proposed difference between similar and interchangeable biosimilars," Ignjatovic said. "The FDA does not consider the science advanced enough to be able to determine whether any two biological products can be deemed interchangeable." Since, biosimilars are made in living organisms and manufacturing processes are trade secrets, generic versions of biologics cannot be kept identical to their reference products and are effectively not "true generics" and need to be treated differently from generics of small molecule drugs, the report noted. Meanwhile, the innovators and the generics industry can not agree on the 12 years of market exclusivity clause, with one thinking it was too long and the other, too short. "The innovative pharmaceutical companies have enjoyed the lack of generics competition for biologics for many years and are unlikely to relinquish it so easily . . . The generics industry wants to see legislation allowing approval of biosimilars to be passed, but not before they are satisfied that sufficient incentives are given to biosimilars manufacturers," Ignjatovic said. With the lack of consensus in Congress, the report said that the bill, which would now have to be considered as a stand-alone bill, was likely to not come into force before the end of this year and would even be possibly postponed until after the 2008 Presidential elections.
The report is available from Piribo here .