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Biosimilars: Europe 14, US 4

In the fall of 2010, the EMA released draft guidelines for development of biosimilar monoclonal antibody products. While just a draft, this guideline is an important step forward in the development of biosimilar Mabs, many of which will come off patent this decade. This guide follows the already published general guidelines for development of biosimilars and specific guidelines for five recombinant biosimilar products (human growth hormone, granulocyte-colony stimulating factor, erythropoietin, alpha interferon and human insulin). These guides, along with the pending Mabs product guideline, cover at least 36 separate marketed biopharmaceutical products. There are already at least 14 approved biosimilars on the market in Europe.

By very stark contrast, we are only aware of four “biosimilars” currently approved in the United States: Omnitrope, Fortical, Hylenex, and Glucagen. These recombinant protein products were approved using the generic drug 505(b)(2) pathway, since the original innovator products were approved by CDER under the NDA regulations. The 505(b)(2) approval pathway is typically applied to generic “small molecule” drugs and is only available for those drugs approved under the NDA pathway. Since most biopharmaceutical products are approved under the BLA (or older PLA) regulations, the 505(b)(2) pathway is not applicable. The recently-passed health care legislation established a legal basis for approving biosimilar products more broadly in the US, but the rules for exclusivity periods and intellectual property are tilted so heavily towards the “innovator” companies, it is hard to see how any sane business would want to develop biosimilars under these terms. FDA has yet to establish the necessary regulatory framework for biosimilars to be approved under this new legislation and, given the preliminary nature of the open forum held last fall, there appears to be no apparent urgency for FDA to move the process forward. It, therefore, seems likely that it will be some time before we see even draft guidances from FDA on this topic.

At this rate, by the time an economically viable pathway is established in the US for biosimilar products, there will be dozens of biosimilars covering a broad range of biopharmaceuticals already approved in Europe and elsewhere in the world. This means European companies, regulators, patients, and prescribers will have far more experience with developing, approving, marketing, and monitoring biosimilar products, endeavors that will require significant innovation in a number of areas leaving the US to play catch-up in all of these areas where others will have written the ground rules.

One of the factors behind the failure of the US to be at the forefront of innovation in the biosimilars arena is the influence of innovator companies and industry lobbying organizations on our political landscape. These groups have successfully put forth the argument that biosimilars will stifle innovative research and reduce investment in into developing new medicines. We believe that the notion that biosimilar development will have a negative impact on innovation is tenuous at best and wrong-headed at worst. There are many ways to encourage and stimulate innovation in biopharmaceutical research; preventing biosimilar development should not be one of them.


Blog article by: Tom Ransohoff and Howard Levine