What are Biosimilar Drugs?

Dragonfly is focused on the development of high quality biosimilar drugs for monoclonal antibodies. Biosimilar drugs are protein-based biologic drugs which are follow-on or generic versions of the originator drugs, similar to generics for small molecule pharmaceuticals. Biosimilars, like generic drugs before them, will emerge as an accepted and important class of medicines, benefiting patients both by lowering costs and improving access to important therapies. Dragonfly is committed to becoming a leader in this emerging area.

Monoclonal antibodies are among the most successful drugs pioneered by the biotechnology industry. Currently several monoclonal antibodies rank among the top ten selling drugs with worldwide sales exceeding five billion dollars per year in some cases. However, there have been no biosimilars for monoclonal antibodies approved in the highly regulated markets.

New Approval Pathways Open Opportunities For Biosimilars

Manufacturers of therapeutic mAb drugs have enjoyed exclusivity and virtual monopolies due to patent protection but also due to the lack of regulatory mechanisms to approve generic versions of the originators. This situation has changed dramatically in the past several years. Europe has led the way in permitting the approval of biosimilars. The European Medicines Agency (EMA) has provided regulatory guidelines for biosimilars, and currently over 10 biosimilar products have received marketing approval in Europe. These have all been first generation biosimilars for growth factors used at low doses such as growth hormone and Epo. Japan has followed with its own biosimilars approval pathway. In the US, legislation granting the FDA authority over biosimilars was passed as part of the 2010 healthcare reform legislation.

The global biosimilars industry is forecasted to be a multibillion dollar market in the next ten years, fueled by increasing sales of biologics, upcoming patent expiries, and the new regulatory landscape. $30+ billion in sales of mAb products alone will be going off patent beginning in 2014.