Biosimilar medicines are developed to be highly similar to a biological medicine which has already been approved and made available for patients.
They can be developed by manufacturers once the original patent for the product has expired. They are called "biosimilar" because the molecular structures are so complex that it is not possible to produce an absolutely identical drug to the original - referred to as the "originator". With smaller drugs, such as non-steroidal anti-inflammatory drugs, it is common for different manufacturers to produce identical "copies" of the originator drug, known as "generic" drugs.
Why make biosimilars?
Biosimilar medicines are developed in order to provide alternative products, usually at a lower cost than the original biological medicine.
Inflectra and Remsima have been approved as biosimilar versions of infliximab and Benepali and Erelzi have been approved as a biosimilar of etanercept (Enbrel).
In autumn 2018 biosimilar adalimumab will be launched.
Regulations for biosimilar medications
Once approved, a biosimilar medicine is recognised to be a highly similar version of a biological medicine and should have comparable quality, safety and effectiveness.
Biosimilars introduced into the UK market first have to be approved by the European Medicines Agency (EMA). They go through a regulatory process which requires comparability studies that demonstrate equivalence to the originator product in terms of quality, efficacy and safety.
Use of biosimilars in rheumatology
Biosimilars might be used as a first anti TNF, as a different option when an anti TNF has failed or as a cheaper option to an originator or reference product. The British Society for Rheumatology has produced a position statement on the use of biosimilars.
We know that since of launch of biosimilars, a lot of rheumatology departments have taken the decision to move people from originator drugs to the biosimilar. This is because the biosimilar is less expensive. If you have been contacted by your rheumatology department about switching we would expect:
- The initial letter or contact should include information about the new medication. Quite a few people tell us their letter has included a simple fact sheet.
- There should be an opportunity for you to discuss the switch in more detail – whether that’s in a group meeting or a one to one discussion with a member of your rheumatology team
- Training on the new device to be offered