19 December 2014
As long as manufactured goods have been around, “me-too” preparations have been around. When a successful thing is introduced, competitors produce a similar one, but sufficiently different not to infringe patent laws.
When Renault introduced the first people carrier, the Espace, it was not long before most other car makers brought out people carriers. It has been the same with SUVs with each version being uglier than the last.
The same thing happens in medicine. The costs of developing a brand new drug are enormous. There are two ways a manufacturer can avoid these development costs. One of these methods is available as soon as a new drug is launched while the second has to wait until the patent on the drug runs out.
A good example of the first method of avoiding development costs while sharing some of the profits are the Angiotensin-2 Receptor Blockers (ARBs). Losartan was the first to be launched and was followed very shortly by Valsartan and Irbesartan. These were sufficiently different to avoid any costly infringement of patent cases. The drug manufacturers are very aware of what is going on in the new drug development field. Virtually always nowadays new drugs such as exenatide and saxagliptin are followed to the market place by me-too drugs.
The second method of avoiding development costs is to wait until the patent on a drug runs out and then produce a copy which is known by the technical gobbledegook name of “bio-similar drug”. These drugs used to be produced and marketed under the generic name. For example, cimetidine is the same as tagamet.
Nowadays, the profits are so great that it is worthwhile for a manufacturer to produce an identical drug to a market leader under their own proprietary name. This is about to happen in the insulin field where a copy of Lantus, called Abasria, is about to be marketed. The problem with insulin is the delivery system. Abasria is being produced by one of the existing manufacturers in the field, Lilly, who do not have a long-acting analogue insulin of their own. They will, however, be able to use their own cartridges and disposable pens. What will happen when a manufacturer not, at present, in the insulin field, produces an insulin copy is anyone’s guess. Presumably, cartridges and disposable pens have similar patents and could be copied.
It is rather poignant that Lilly, who produced the first ever insulin back in 1922 and were in the forefront of insulin development until very recently are now reduced to copying successful preparations.
Does it matter whether you use the original drug or the copy? Probably not, and the copy will undoubtedly be cheaper. But it is generally not thought to be a good idea to switch from one to the other indiscriminately. It is quite possible that the bioavailability (the way and degree to which the drugs work) of the two preparations may differ. And, of course, to switch from Lantus to Abasria would need new devices prescribing.