In no other field are biologics as important as in oncology and biosimilars are expected to be equally dominant players. Six of the 10 top-selling biologics in the United States are used in oncology, according to a 2011 review of biosimilars by Bradford Hirsch, MD, and Gary Lyman, MD, MPH (J Natl Compr Canc Netw 2011;9:934-942, PMID: 21900222).
And they are very expensive: The number one money-earner in 2009 was bevacizumab (Avastin, Genentech), with sales of $5.8 billion. It was followed closely by rituximab at $5.7 billion. At $5 billion and $4.9 billion respectively, the markets for epoetin alfa and trastuzumab (Herceptin, Genentech) were not far behind.
In Europe, draft biosimilar development guidelines were released in 2004. The first product—epoetin alfa Hexal (Hexal)—was approved in August 2007 and now more than a dozen biosimilars are on the market. Erythropoiesis-stimulating agent biosimilars such as epoetin alfa account for 35% of the market (NCCN Biosimilars White Paper. J Natl Compr Canc Netw 2011;9:S1-S22, PMID: 21976013) and are marketed at a 25% to 30% discount from the “originator” or “reference” product, according to Drs. Hirsch and Lyman. This also has led to price reductions of the reference products themselves.
The European Generic Medicines Agency estimated in a “Vision 2015” document that the European Union (EU) saved 1.4 billion euros (US$1.8 billion) from biosimilar use in 2009. Another analysis projects the total savings to exceed 8 billion euros (US$10.6 billion) by 2020. Most experts believe that overall, biosimilars will cost 20% to 30% less than reference products. Some project that in the United States, this will result in $25 billion in savings per decade. Others peg the windfall as high as $108 billion in the first 10 years and $378 billion over 20 years (Targ Oncol 2012 Jan. 17. [Epub ahead of print]).
Biosimilar versions of simple, unmodified biologics may well be approved and accepted relatively quickly in the United States because companies have gained experience with biosimilar approval in Europe. Thus, it is possible that they will be marketed for less than their European equivalents.
However, the price reductions with biosimilars will never be in the same ballpark as generics. Generics can be accompanied by price tags that are as much as 90% lower than their brand-name counterparts. Biosimilars are made in living systems and are much more complex, and the steps regulators require for product testing and approval are concomitantly more onerous in both the United States and Europe. The estimated cost to bring a biosimilar to market is $10 million to $40 million and the time frame is six to nine years, compared with $1 million to $2 million and three years for generics.