May 9 saw the latest estimate of the potential size of the market for biosimilar drugs—$167 billion by 2017, according to Companiesandmarkets.com. It’s an exponential leap from the estimate made earlier this year by Frost & Sullivan that biosimilar sales will reach $23 billion in 2019, up from what it estimated as $1.2 billion in 2013 sales.
The past few years has seen a flurry of worldwide activity by drug developers in creating, winning regulatory approvals for, then launching biosimilars. The operative word here is “worldwide”—Europe remains miles ahead of the U.S. The European Medicines Agency authorizes 18 biosimilar drugs for market in the nations comprising the EU. Meanwhile in the U.S., the FDA continues to ponder draft guidances for how the agency will evaluate biosimilars.
FDA insists it is moving ahead with careful review of new regulations. FDA’s Center for Drug Evaluation and Research (CDER) earlier this year published an agenda for new and revised draft guidances that included several new topics the agency said will be addressed: clinical pharmacology data to support a demonstration of biosimilarity to a reference product; considerations in demonstrating interchangeability to a reference product; labeling for biosimilar biological products; and reference product exclusivity for biological products. CDER also included a biosimilar topic published in previous agendas, additional questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009.
One reflection of increased activity: This year’s list reports on 11 biosimilars to watch, as Avastin (bevacizumab) and Erbitux (cetuximab) have been added to reflect an uptick in announcements or disclosures about biosimilar versions of those drugs since 2013, while Genotropin (somatropin or somatotropin) has been removed for not generating as much activity.
Following is a list of 11 drugs for which, over the past year, biosimilars have been launched to market somewhere in the world, were in clinical development, or whose development was ended. Drugs are listed by original brand name (generic name), followed by a list of drug developers with a brief summary of the status of their biosimilar, and its name where known; the nature of the drug and its indication; its 2013 sales (and the original drug’s maker or makers); and the drug’s patent status in the U.S. and EU.