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Biosimilars - what you need to know

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Simon O’Neill, Director of Health Intelligence, at Diabetes UK, explains why people with diabetes need to be aware of biosimilar insulins, biological copies of insulins which are no longer in patent.

“Biosimilar insulins are about to make their way onto the UK market. That means people with diabetes and their healthcare professionals need to be better informed about them so that they can make the right choices.

New drugs are normally protected by patent and also have to get marketing authorisation from the European Medicines Agency (EMA). Eight years after the original marketing authorisation of the original drug has elapsed, other manufacturers are allowed to make generic versions and submit them for approval by the EMA, and, if approved, these can be marketed in the EU.

Generic versions of drugs are commonly used within the NHS as they tend to be much cheaper than the original patented drug. Generic drugs are virtually exact chemical copies of the original drug and therefore don’t need to go through lengthy trials before being licensed.Although most of the patents on existing insulins have expired or are due to expire in the next few years, there are currently no “generic” versions available on the UK market. This is because, with biological drugs, such as insulin, it is impossible to make an exact copy which can be guaranteed to react in exactly the same way as the originally approved drug. A biological copy, called a biosimilar rather than a generic version, can’t be said to be identical to the original. This is because tiny changes in the structure of the product and in the manufacturing process can change the way the drug works. Biosimilars therefore require further testing and further EMA approval.However that is all set to change.  Abrasia - Lilly's version of  Sanofi’s Lantus - has got EMA approval so once Sanofi’s patent runs out early in 2015 then Lilly can go to market.

Many biosimilar insulins already exist and are licensed in other countries where they do not need FDA or EMA approval.Our advice is that people who are already established on an insulin and achieving good control should continue with that treatment and not be made to change to a biosimilar.

However, if people with diabetes choose to switch to a biosimilar insulin they should be encouraged to monitor their blood glucose more closely to ensure that good control is achieved.

Choosing what insulin is right for you needs to be a decision made jointly between the person with diabetes and their healthcare professional.

The first biosimilar on the market will be Abrasia, sometime in 2015, but many are likely to follow. As with all insulins, biosimilar insulins should be prescribed by their trade name rather than the generic insulin name to ensure the correct insulin is dispensed. This is essential for biosimilar insulins to avoid substitution of an unfamiliar insulin without discussion and warning at each prescription.Visit our position statement onbiosimilarsto find out more.

 

 

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