Generic Biotechnological Drug Issues

October 3, 2008 by vikas

The respected scientific journalist W. Wayt Gibbs, writing in Scientific American (2003), has suggested that many of the issues associated with concerns about the high costs of individual bioengineered protein drugs will go away when the patents lapse and generic drug manufacturers become involved.

Gibbs correctly identified some of the issues when generic “copies” of established drugs became available to the public. However, he may be in error in suggesting that the cost of “biotech” or “biologics” would decrease very much for the simple reason that these drugs are not prepared in the same way as small molecular weight drugs. The new generation of drugs now available are typically large molecular weight proteins constructed within biological systems such as yeast or E. coli cells and the proteins need to be folded in certain critical ways to be biologically
active. In addition, their properties are affected by the additional attachments of sugars and other moieties that control their solubility, stability, and availability. These syntheses are quite different from the relatively simple small chemical entities and will certainly be more difficult to replicate. There is also the problem of available facilities for making these drugs, such as the fermentation plants required to grow the biological cells. There is currently a shortage worldwide of fermentation capacity and this will also inhibit generic competition.

There are other issues associated with the generic industry that require resolution. The pharmaceutical industry at present consists of two main components: originators and generic copyists. Originators discover a drug entity, patent it, develop methods of analysis and delivery, and carry out clinical and toxicological tests before developing a marketplace. On the other hand, once the patents have expired competitors are able to do an end-run around much of this testing and research, enabling them to put the drug on the market more cheaply. This is in principle; in fact it is noticeable that many of the generic prices are only slightly less than those of the originator.

It is the patent system which encourages this competition but there have been instances where the technology has been pirated before the patent(s) expire. Since originators may have to spend up to a billion dollars before a new chemical entity enters the marketplace, it is not surprising that the entry price is high since, commercially, this nvestment has to be recovered. Depending on the length of the remaining patent life this investment has to be recovered before competition appears on the market place, after which, in principle, market forces take over to drive the price down.

This whole issue has become a political discussion point, and in countries like Canada there is legislation to ensure that the final price is more acceptable to the consumer. This may happen in the United States but at present there is no clear answer to the problem, especially if insurance or government agencies will not carry the cost.

Returning to biologics, it seems that the technology is so specialized that any intervention by generic drug manufacturers when the patent(s) expire is unlikely to significantly reduce the cost to the consumer, and it may well be much less than that anticipated by some journalists.

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