To Market, To Market – First U.S. Biosimilar On Its Way

On Wednesday, January 7, 2015, I attended the Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee meeting that discussed and recommended approval of the first biosimilar drug, called filgrastim, under the Biologics Price Competition and Innovation Act (BPCI).  It was an exciting and historic event. Citizens Against Government Waste (CAGW) has written about the importance of biosimilars for some time.  BPCI was one of the few good things that came out of the Affordable Care Act (ACA), better known as ObamaCare, which was signed into law in March 2010.  BPCI created an abbreviated pathway for bringing the “generic” versions of biologic drugs, more properly called biosimilars, to the marketplace.  Biologics are made from living organisms, as opposed to chemically-based drugs.  In addition to a biosimilar providing a safe and effective alternative to the brand-name product once its patent has expired, a November 2014 Rand Corporation study found that introducing competing biosimilars could cut spending on biologics by $44 billion over the next decade. Filgrastim is the generic name for the brand-name drug Neupogen®, which is manufactured by Amgen.  Filgrastim boosts the production of neutrophils, a type of white blood cell that fights infections.  The drug is utilized to reverse neutropenia, an abnormal condition in which there are not enough neutrophils, often a side effect from cancer treatments. Neupogen® went off of patent protection in 2013, thus opening the door for competition in the U.S.  In July 2014, Sandoz, submitted the first biosimilar application under BPCI to the FDA for filgrastim.  Sandoz is the generic division of Novartis, a global pharmaceutical company.  Sandoz, based in Germany, has marketed its filgrastim biosimilar, called Zarzio, in the European Union (EU) since 2009; in Australia since 2013; and in Japan since early 2014.  It is currently sold in more than 40 countries. The U.S. lags far behind Europe in the marketing and use of biosimilars.  The EU has been approving biosimilars for the marketplace since 2006. The advisory committee said the data presented by Sandoz showed their filgrastim biosimilar has no clinical differences with the Amgen product Neupogen®.  But in spite of this good news, more decisions and controversies remain. One major decision still pending is if the International Non-Proprietary Name (INN), or generic name, should be shared by both the brand-name biologic drug and its corresponding biosimilar.  (In this case filgrastim would be the INN.)  The World Health Organization (WHO) created the INN system over 60 years ago.  WHO states, “the existence of an international nomenclature for pharmaceutical substances, in the form of INN, is important for clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide.” CAGW has been involved with INN issue since last year.  In July, 2014, we wrote a letter to the FDA on the naming controversy, urging them to adopt the European model of brand-name biologics and biosimilars sharing the same INNs.  But there have been calls for the FDA to utilize a unique naming system; different INN names for each brand-name biologic and each corresponding biosimilar.  CAGW believes this suggestion is nothing more than an effort to stifle access to competitive products. Just recently, the American Medical Association (AMA) has indicated it will recommend to the FDA that brand-name biologics and their corresponding biosimilars share the same INN.  According to Inside Health Policy, the AMA has raised “concerns surrounding unique naming for biological products, saying that nonidentical INNs may suggest to prescribers that the active ingredient in products is different; create the impression that interchangeable biosimilars have important, clinically relevant distinguishable effects; and reduce uptake and substitution of interchangeable biosimilar products.” The other major issue to be decided by the FDA is interchangeability.  The FDA has not issued specific guidance on interchangeability – when a biosimilar can be substituted for the brand-name biologic.  The FDA considers interchangeability to be a higher standard to meet although according to the Generic Pharmaceutical Manufacturing Association “no other global regulatory agency makes a distinction between biosimilarity and interchangeability.” Amgen and Sandoz still have other issues to work out called the “patent dance.”  In this case, both sides have differing views on what BPCI requires with regard to exchanging patent information such as manufacturing processes. Hopefully the FDA will give official approval for the biosimilar by March and patients will have access to it by the end of the year.   You can read more about CAGW’s work in the biosimilar area here: https://www.cagw.org/media/press-releases/cagw-releases-poll-results-regarding-use-biosimilar-drugs-0 https://www.cagw.org/in-the-news/2014-11-11-000000 https://www.cagw.org/media/wastewatcher/name-game http://ccagw.org/media/press-releases/ccagw-fda-no-more-name-games http://swineline.org/?p=9118