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Clexane® (Enoxaparin) Biosimilars: practice guidance on ensuring brand consistency

Friday, September 8, 2017

National Procurement have been in touch with CPS to provide our members with some background and safety information on an upcoming drug launch which may alleviate some of the supply pressures experienced with Clexane® in recent months:

The originator brand of enoxaparin is Clexane® (Sanofi). Two biosimilars of Clexane® will launch in autumn 2017; both products are entering the UK market quicker than anticipated to provide support during the on-going Clexane® supply constraints.

A biosimilar medicine is a biological medicine that is similar to another biological medicine which has already been granted a marketing authorisation. Although biosimilars and their reference biologic share a generic name, they are not presumed to be identical in the same way as generic non-biological medicines. To support pharmacovigilance and to ensure any switching between brands is authorised by the prescriber, the MHRA advise that biological medicine (including biosimilars) should be prescribed by brand name.

Currently a high proportion of prescriptions for enoxaparin in primary care are issued by generic name and do not specify a brand. Work is underway across Scotland to transition across to branded prescribing. In the interim, if a generic prescription for enoxaparin is received by pharmacies, pharmacists should confirm which brand the patient has been receiving, dispense this brand and endorse the prescription accordingly to ensure correct payment.

It is possible that there will be further disruption in the supply of Clexane (40mg strength) in late November. Sanofi have agreed to protect supply to community pharmacies in line with historical demand. In the event that it is not possible to source Clexane from wholesalers,  the prescriber should be contacted. Due to differences in device design between the reference product and biosimilars, patients who self-inject that are switching from one device to the other will need to receive advice on the change.

More information about biosimilar medicines can be found in the Biosimilar Medicines: National Prescribing Framework which has been developed by Healthcare Improvement Scotland, in collaboration with NHS Boards and Area Drug and Therapeutics Committees.