Biosimilars regulations 
unlikely to unfold soon

As soon as members of Congress took their seats last month, the new Republican majority announced it would make good on its pledge to repeal the Patient Protection and Affordable Care Act. The effort largely is symbolic and unlikely to succeed, so at least one portion of the healthcare-reform law will likely remain in effect, namely the abbreviated approval pathway for follow-on biologics, also known as the Biologics Price Competition and Innovation Act.


In November, the Food and Drug Administration sponsored a public meeting to collect input from interested parties about what form regulations for follow-on biologics will take. The meeting was attended by the Pharmaceutical Research and Manufacturers of America, the Biotechnology Industry Organization and the Generic Pharmaceutical Association. In all likelihood, it will be a while before draft regulations come out; GPhA VP regulatory affairs Gordon Johnston and IMS Health VP industry relations Doug Long said guidance for draft regulations could appear this year.


“Historically, regulations have been slow to come,” Johnston told Drug Store News, noting that regulations for generic pharmaceutical drugs didn’t appear until four years after the 1984 passage of the Hatch-Waxman Act. “But certainly there’s a lot of interest in moving the process along, so I expect in 2011 we’ll see some sort of significant guidance or perhaps even draft regulations from the agency.”


Long thinks the process could take longer. “In discussions with others, there is a belief that it will be three years from the time of final guidance to see biosimilars on the market,” he told Drug Store News, saying that guidance could be issued in the latter half of 2011, but this was “very optimistic.”


Whatever the timeline, manufacturers aren’t sitting idly by. Teva Pharmaceutical Industries, the world’s largest generic drug maker and a major supplier of biosimilars in Europe, has sought to win approval for biosimilars in the United States using the existing unabbreviated pathway for biologics. So far, the Israeli company has had mixed results. It recently began marketing its generic version of Sanofi-Aventis’ anticoagulant Lovenox (enoxaparin), which the FDA approved as a pharmaceutical, though many experts said its chemical complexity places it more in the league of biologics. In September, Teva received a complete response letter from the FDA to its application for Neutroval (filgrastim), a biosimilar of Amgen’s Neupogen. Last month, Spectrum Pharmaceuticals and Viropro announced plans 
to develop a biosimilar of Genentech’s cancer drug Rituxan (rituximab), while Merck announced a deal with drug industry services firm Parexel International to develop biosimilars.


When a formal regulatory process takes shape, it is likely to look quite different from the one for generic drugs. For one, follow-on biologics will cost a lot more to develop. According to a 2006 study led by Duke University economist Henry Grabowski and published in the journal Health Affairs, simply building cell culture facilities can take three to five years and cost anywhere from $250 million to $450 million, which will keep the pool of manufacturers small. 


On top of that, manufacturers must conduct clinical trials to prove their follow-on biologics are comparable to the originals, something that BIO and PhRMA strongly support, but that will incur additional costs for any prospective manufacturer.

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