Interview with Malcolm Ross

Written by: Fleming. Team

What is the major difference in the registration of value-added generics in the US and the EU?

The processes are quite different. For a start, in the US there is no option – the filing will be with the FDA, whereas in Europe it may be possible to pick a particular agency that may be known to be more flexible in reviewing this type of product.

Why are supergenerics getting more attention from big pharma players?

According to my definition of supergenerics, it is possible for innovative companies to look at ways of improving existing products by reformulating or repositioning. It is nothing to do with "big" pharma – it has to do with the mindset of the company. Obviously, if it is a "supergeneric" from the originator, then to my mind this is life-cycle management rather than a supergeneric.

What is the difference between supergenerics and new therapeutic entities?

New therapeutic entities are essentially supergenerics, but not all supergenerics are new therapeutic entities.

What are the main approaches to generic product innovation?

Today there are two sorts of generic companies – the pure generic players (commodity generics) and the hybrids, which have both commodity and value-added generics. By and large it is the bigger players who can devote the time and energy to the innovative side of generics. It isn't so much the "innovation" that is the barrier; it is the capability of supporting the regulatory and IP plus marketing that can make or break an innovative generic product.

Where do you see the future of generic industry in 10 years?

We are seeing a major change in the generics industry at this moment. Some companies are getting out of generics (Allergan's sale of Actavis to Teva or Valeant's recent acquisitions) or maximizing their branded products over their generics. This will leave a space for the traditional generic company to fill, but many of the companies that would be expected to fill this space are facing serious compliance issues at this moment, particularly in India and China, and the situation does not seem to be improving. So my predictions for the next 10 years are:The big generic players will essentially leave the generic arena, with the exception of Teva, which will remain a hybrid – a little like Novartis being the only innovator company with a serious generics division.The Indian and Chinese companies will continue to have regulatory issues for at least the next five years.We may see a return of European generic manufacturers to fill the credibility gap left by some of the companies with regulatory problems.Finally, biosimilars will not prove to be the money makers that have been predicted to be in the past.However, I would remind you that in 1977, Ken Olsen, founder of Digital Equipment Corporation, said "There is no reason anyone would want a computer in their home." He was very wrong and most probably so am I.