Trends in 2009: Facing the Challenges of Introducing Biosimilars or Follow-on Biologics in the North American Market
February 17, 2009
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The so-called biotechnology drugs or biologics (large, complex protein molecules derived from living cells, usually by use of recombinant DNA technology) are among the fastest-growing class of pharmaceuticals. Within the next two years, some market forecasts predict that biopharmaceuticals will amount to more than 50% of newly approved medicines. In addition to a growing market share, a substantial number of major biotechnology-based drugs will come off patent and enable the development of new biologics. The race by pharmaceutical companies to get into biologics, or further support their existing biologics capacities in order to start developing biosimilars or follow-on biologics (FOBs), is illustrated by the rapid pace of recent deals in this sector. The latest of these deals is the acquisition of Insmed by Merck, which was announced last Thursday; however I believe this deal was more about expanding state-of-the-art manufacturing facilities rather than acquiring extremely valuable FOBs.
One of the major challenges in developing FOBs is indeed the ability to address the complex manufacturing processes that are involved in developing a generic biological drug that is comparable to the original branded product. Such challenges include an appropriate production process, an efficient and versatile glycosylation platform, and sophisticated analytic tools for comparability assessment.
Even if most of the challenges highlighted above can be met, the promise of introducing FOBs in the North American market remains largely dependent on the establishment by Congress of a legal pathway and clear regulatory guidelines for the approval of biosimilars. The European Medicines Agency (EMEA) has had a legal framework in place for approval of biosimilars since 2004, and since then over ten biosimilars for various biologic drug classes have received marketing approval in Europe to date, with an FOB for Neupogen being the latest product which received final approval just last Friday. In the US, however, Congress has urged the Food and Drug Administration (FDA) to develop a regulatory approval pathway for FOBs, but the agency has been reluctant to act without receiving legislative authority. With the Obama administration now in place, it is hoped that a biosimilars approval bill be enacted later in 2009, with the first FOB approval in 2011. Nevertheless, before this can happen, there are other significant and unresolved legal issues implicated in the discussion of whether and how to approve FOBs. For example, there are serious questions about how FDA, in approving biosimilars, could avoid unauthorized reliance on the innovator’s protected trade secret and confidential commercial data and information. Such unauthorized reliance would violate not only section 505(b)(2) of the Food, Drug and Cosmetic Act (FDCA), but also the Trade Secrets Act and the United States Constitution.
As far as Canada’s legal and regulatory framework with respect to approvals of FOBs, Health Canada released a draft guidance document in March, 2008, which outlines submission requirements for what they refer to as Subsequent Entry Biologics (SEBs). Although this is a very proactive and positive step from the Canadian regulatory authorities to jump-start the process of facilitating approval of FOBs in Canada, it is generally believed that health Canada may end-up laying out guidelines that are more akin to what FDA does rather than emulating the legal framework of EMEA.