By Michael Fitzhugh
Merck (NYSE:MRK) BioVentures is enlisting Parexel International (NASDAQ:PRXL) to help test and develop its most promising biosimilars as it prepares to negotiate both late-stage trials and regulatory policies in the United States and Europe that are creating a path to approval for such medicines.
Unlike generic drugs which are chemically synthesized small molecules, the complexity of the large molecules that constitute biotech therapeutics and the fact that they are derived from living cells means it is possible to make similar, but not identical, products. While short of exactly copying biotech drugs, biosimilars promise to match their functions for less money.
Recognizing an emerging wave of biosimilar competitors as the U.S. Food and Drug Administration moves to establish a pathway for approval of biosimilars for products that have lost patent protection, big pharmaceutical companies have rushed to get in on the action. In some cases companies are forming partnerships with biosimilar developers. In other cases, such as Merck, they are developing biosimilars on their own.
Merck established its BioVentures unit in 2008. In 2010, it reported that it anticipated having five biosimilar programs in late-stage development by 2012.
Like many pharmaceutical companies, Merck has embraced outsourcing as a means to slash internal costs as revenue from the sales of its portfolio of proprietary medicines declines. The extra horsepower it derives from Parexel will help guide the company through the biosimilars approval process as both the industry and governments put new biosimilar regulatory pathways to the test in 2012 and 2013.
Merck BioVentures president Michael Kamarck says Boston-based Parexel was chosen for its proven biosimilar clinical development experience.
Parexel will provide both regulatory strategy and clinical development support for “certain broad classes of biosimilars” through a new internal unit dedicated solely to Merck BioVentures. No financial details about the arrangement were released.