Biobetters a big opportunity for biopharm and CROs

By Nick Taylor

- Last updated on GMT

Related tags: Chief operating officer, Clinical trial, Contract research organization

Biobetters, more than biosimilars, are the big opportunity for biopharm and CROs hoping to profit from biologics patent expirations, say experts.

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.

Biobetter players

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.

Healthy cocktails

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.

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S Korean Companies and Biosimilars

Posted by Pete Lassoff,

Agree, Porter has no idea what he's talking about. S Korean firms are at the forefront of biosimilars and biobetters and those who doubt their commitment and think that they're not serious or naive are simply delusional.

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What is there to be naive about?

Posted by Asa Cox (,

Interested to know what South Korean needs to learn/experience in order to be considered a serious player?

The government is throwing money at the sector and the domestic market is healthy.

Is it a lack of internationalisation?

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