The Biosimilar Blog makes the Biosimlar score: Europe 14 US 4.
Europe has been out ahead of the US in creating guidelines and a regulatory pathway for biosimilars to reach its market. They have guidelines in place to cover at least 36 separate marketed biopharmaceutical products and 14 products are already approved.
The US has only 4 approved "biosimilars" - being Omnitrope, Fortical, Hylenex and Glucagen. None followed a true biosimilar regulatory pathway as there isn't one yet in the US. The legislation has just passed and the FDA is still in the lengthy process of establishing the regulatory framework for biosimilars to be approved under the new legislation. It appears this will take a while.
In the meantime, the only way generic recombinant proteins can get licensed is via the generic drug 505(b)(2) pathway. And this only will be applicable if the drug in question was approved via CDER with an NDA - which normally is used only for small molecules. Most biopharmaceuticals are approved under a BLA thorough CBER and therfore can't use 505(b)(2).
The authors worry that the US will dicker too long and be left out from being in the forefront of developing biosimilars regulations in the world stage. Other geographies will lead the way and gain the upper hand in promulgating the regulations and gain experience working on them while the US is still drafting.
The authors plea for US constituencies to stop worrying about protecting innovators by blocking biosimilar competition and worry about creating a pathway whereby biosimilars can be approved --- like the rest of the world is doing. They further note that there are many other ways to provide innovators with incentives to keep innovating (permanent R&D tax credit anyone?) but that blocking biosimilars shouldn't be one of them. Let's get in the game.
Posted by Bruce Lehr March 12th 2011.