The US FDA may not have published its guidelines yet (though we're told they're coming soon) as to how biosimilars will be approved, but big companies continue to step into the fray to get ready. Boehringer Ingelheim is the latest to announce that it is creating a biosimilars division to get in on the expected action.
BI Director Wolfram Carius said "We feel confident that we are able to leverage our capabilities in product development, supply and clinical expertise at Boehringer Ingelheim to offer high quality biosimilars understanding patients' needs."
In addition to traditional big biosimilars' players like Teva, Sandoz and Hospira - now we have companies like Merck with its Merck BioVentures group, Pfizer and BI joining the party. Even though biosimilars are supposed to save the health care system on costs, the FDA is expected to require a fair amount of animal and human data to show comparability to the licensed reference product. Thus chasing biosimilars will likely be a game for the rich companies in the US -- at least at the beginning. See Fierce Biotech too.
Posted by Bruce Lehr Sep 27th 2011.