Between 2011 and 2013, many insulin manufacturers will see several important insulin analogues coming off patent, and therefore will be available for many other companies to produce and market, with copies of current branded insulins named ‘biosimilar insulins’. Many medications for diabetes in the past, such as metaformin, once off patent have been easily reproduced, once the company shows that they are keeping to the original formula, is pure and manufactured consistently.
But proteins like insulin are different, trying to replicate insulin can be very difficult & complex. Therefore this is why drug regulators do not refer to ‘generic insulins’ as they would with medications, but have introduced the term ‘biosimiliar insulin’. Purification of the insulin can prove to be challenging as impure proteins may be recognized by the body as foreign and stimulate the generation of antibodies. These occasionally cause allergic reactions, or neutralizing the effect of the insulin itself, therefore losing its efficacy.
Because of the amount of regulations and red tape, it is highly unlikely that these insulins will be cheaper than the originals. Neither is there no guarantee that these new wave of insulins are better or worse than their original counterparts.
Ref: Original Article appeared in ‘Diabetes Voice’ Sept 2011, Vol 56: Issue 2, p.g: 40-43