What do we mean by ‘generic medicine’ and ‘biosimilar medicine’?
When a new medicine becomes available for the first time it is given a brand name (also called trade name or proprietary name). This name and the product are protected by a patent. This is a legal arrangement which prevents other manufacturers from making or selling the same medicine for a number of years. Once the patent has come to an end, other manufacturers can make a similar product, called a generic.
Examples of generic and brand names:
|Brand name||Generic name|
A generic version contains the same active ingredient. The generic version may be a different colour or taste different but will work in the same way as the original product.
Generic medicines are tested so that they meet the same quality and safety requirements as the original product.
Generic medicines are usually less costly than branded medicines as they have fewer research and development costs. This applies to both the NHS and the public buying medicines.
Confusingly, the word ‘generic’ can also be used to mean the non-proprietary name of a medicine.
We can only use the name ‘generic medicine’ when looking a simple medicines, such as the ones in the table above. Large, highly complex medicines are known as ‘biological medicines’ or ‘biologics’. Due to the way they are manufactured, the medicines which follow the end of a patent for a biological medicine are called ‘biosimilar medicines’. These are developed to be similar to an existing biological medicine (called the ‘reference medicine’). Due to the complex nature of the way these medicines are made, variations, even between batches of the same product, are known to occur. Using studies, the manufacturer of a biosimilar medicines needs to show that they are similar to the reference medicine. Often these biological medicines and biosimilars are used in hospitals to treat conditions such as rheumatoid arthritis.
EMA and the European Commission have developed information materials on biosimilar medicines to improve understanding of these medicines in the EU.
An information guide for patients published by the European Commission explains in a clear, unbiased way what biosimilar medicines are, how they are developed and approved in the EU and what patients can expect in terms of availability and safety
Resources – generic medicines:
Resources – biosimilar medicines:
- biosimilar rituximab london and SE MI
- biosimilars in the EU
- LMEN review biosimilar infliximab
- Medicines QA300_4_Biosimilars
- NICE evidence summary_diabetes and insulin-glargine-biosimilar-abasaglar-pdf-1502681105222341
- NICE key therapeutic topic biosimilar medicines
- NICE biosimilars position statement
- Product safety assessment report Infliximab
- UKMi Benepali biosimilar-Jan-2016
- NHS England – what is Biosimilar medicine guide May 2019