The Burrill Report


Boehringer Ingelheim says it will establish a new separate business to develop and commercialize biosimilars, copycat versions of complex biotech drugs.

"We believe that biosimilars will become a major part of the biopharmaceutical market and will enable many more patients access to important medicines," says Wolfram Carius, a member of Boehringer’s board of managing directors.

The timing of Boehringer’s announcement coincides closely with growing clarity around the future of biosimilars in the United States, where the U.S. Food and Drug Administration is expected to publish details of a pathway for the approval of such therapies within days or weeks, according to various reports.

Biosimilars could also be buoyed by President Obama’s deficit reduction plans, which seek to wring an estimated $3.5 billion in savings from federal healthcare expenditures during the next ten years by shortening the data exclusivity period for brand name biologics beginning in 2012, a change that the administration believes would speed patient access to biosimilars.

Only the most sophisticated and well-funded drugmakers are expected to jump into the biosimilars market at first, because they are the companies most likely to be able to support the development and manufacturing costs of biosimilars. In 2010, Boehringer reported net sales of about $17.2 billion (€12.6 billion).

Other large companies with biosimilars already on the market or in the works include the generics giant Teva Pharmaceutical, Merck, and Pfizer. By 2015, IMS expects spending on biosimilars could exceed $2 billion annually, or about 1 percent of total global spending on biologics.









September 30, 2011
http://www.burrillreport.com/article-boehringer_jumps_into_biosimilars.html