“The game’s not in biosimilars, it’s in biobetters”, said Stephen Porter, chief scientific officer at Dragon Bio-Consulting. John Hubbard, senior vice president, worldwide development operations, at Pfizer, agreed, describing biobetters, not biosimilars, as “the market opportunity”.
A biobetter improves on the original biologic by, for example, reducing the side-effect profile. Improvements can be achieved by identifying how changes to protein folding impact on the effects of a drug.
Bringing these products to market will require clinical trials and this represents an opportunity for contract research organisations (CRO). Mark Goldberg, chief operating officer at Parexel, said his CRO made a concerted effort to enter the sector and has inked a deal with Merck & Co.
A spike in clinical trial activity creates difficulties though. “The biggest struggle is the number of companies going after the same compounds. It’s going to get crowded with people doing the same trials at the same time”, said John Potthoff, chief operating officer at INC Research.
Bottleneck concerns are magnified by the importance of being first to market. Whichever product is approved first is likely to capture a sizable share of the market, unless a biobetter with notable improvements is launched.
Success in biosimilars or biobetters will require some skills associated with generics companies, and others more common at innovators. Partnerships are one strategy companies have used to overcome this problem.
Companies from China and, in particular, the more advanced India are positioned to capture a piece of the market. Samsung is also setting up biosimilar operations but this move, and others made by Asian technology companies LG and Fujifilm, was met with some scepticism.
Porter is concerned about the “naivety” of South Korean companies, LG and Samsung, seeking to enter the biologics sector. Some analysts expressed similar concerns when the Fujifilm and Samsung deals were made public.
In 10 to 20 years time biobetters will be taken as part of a cocktail of products for fighting disease, said Porter. Small molecules, biologics, nutrition and medical foods, which Nestle is investing in, will all play a role.
Pharma is now much more open to opportunities beyond small molecules and biologics, said Hubbard. To diversify sources of revenue pharma companies may increase their presence in sectors outside traditional areas of focus.
Asian companies may also attempt to add traditional medicines to the cocktail. Potthoff said INC is seeing some evidence Asian traditional medicine companies want to break into Western markets.