Until now, the highest hurdle to higher biosimilar sales has been slow acceptance by EMA and FDA, Michael Waterhouse, analyst, specialty pharmaceuticals with Morningstar, told GEN.
“If I had to rank the importance, I think it’s more just getting the regulatory bodies comfortable with the safety of the products in the first place, getting through whatever clinical trials they need to. Then beyond that, you get into building physician confidence in using these products,” Waterhouse said.
Many doctors have been reluctant to prescribe biosimilars, siding with some biopharmas dead-set against losing sales. AbbVie and InterMune sued EMA in March seeking to block release of their clinical trial data as commercially confidential. But biosimilar development has also been slowed by higher producing and handling costs, and the time and expense of additional clinical studies, preventing the scale of price savings seen with generics. Biosimilars cost only 20–30% less than their reference drugs, Erwin A. Blackstone, Ph.D., and Joseph P. Fuhr, Ph.D., said in a 2012 Biotechnology Healthcare study.
Then there’s the ongoing dispute over biosimilar naming. Both sides restated familiar arguments last month at a World Health Organization (WHO) discussion forum: Brand biopharmas and their supporters seek distinct nonproprietary names—containing a common, shared root with distinct and differentiating suffixes—for biosimilars and other biologics. But generic and biosimilar drugmarkers and their supporters say there’s no reason to vary from the WHO’s International Nonproprietary Names (INN) convention, contending the combination of a unique brand name, manufacturer name, NDC code, and lot number ensures full traceability. They also note that biosimilars using the same INN as their reference products have been marketed in Europe since 2006, without problems.
“The outcome of this debate will be critical to the future of the biosimilar industry in the U.S. in particular, but it is important to realize that what is at issue here is not the best way of managing a new situation, but a concerted attempt by certain influential parties to change a system that has already been successfully tried and tested in many highly regulated markets worldwide,” Chris Lewis, a Sandoz spokesman, told GEN.
Sandoz, the generics unit of Novartis, dominates the global biosimilar market with a share of more than 50%. During the first nine months of 2013, Lewis said, Sandoz generated sales of $301 million, up 22% in constant currencies from a year earlier, from its three biosimilars—somatropin, filgrastim, and epoetin alpha.
Sandoz is one of three top biosimilar developers in Europe, Waterhouse said; the others are Teva and Hospira. The small number of top players means smaller sales for every other company.
“Even when you compare it to the typical generic product, a biosimilar is still a much more attractive opportunity for them, just because if you’re only looking at three competitors, it’s much different than when you have Lipitor going generic, and after the exclusivity period, you have 10 or 12 people coming into the market. And that’s just not something we see occurring in the biosimilar area,” Waterhouse said. “Most of these molecules will probably have maybe one, two, or three at most biosimilar competitors. In general, that would tend to uphold pricing much, much better than most generic drugs.”
Developers will need those higher prices, since the cost of developing a biosimilar ranges from €100 million ($134 million) and €250 million ($334 million), according to the European Generic Medicines Association, versus just millions for generics (estimates vary based on complexity, from $1 million to $4 million [IMS, 2011] to $50 million [Datamonitor and Canada’s Better Pharmacare Coalition]). U.S. biosimilar development costs could rise higher, Waterhouse said, depending on how much FDA will ultimately require in clinical trials to show comparability, as well as where drug developers manufacture their products.