asked Her Majesty's Government:

Which biosimilar medicines have been approved for use in the United Kingdom; and [HL1137]

Whether they have considered banning the automatic substitution of branded pharmaceutical preparations by comparable biosimilar medicines; and [HL1138]

Whether they plan to introduce requirements for patient information leaflets to be prepared to specify the possible risks associated with biosimilar medicines, as appropriate. [HL1139]

The Medicines and Healthcare products Regulatory Agency has granted marketing authorisations for the following biosimilar medicines:

Omnitrope (somatropin);

Valtropin (somatropin);

Epoetin alfa hexal, Abseamed, Binocrit (all containing epoetin alfa); and

Silapo, Retacrit (both containing epoetin zeta).

We are not aware of any legal basis for such automatic substitution. Section 58 (2)(a) of the Medicines Act 1968 provides for prescription-only medicines to be sold or supplied only in accordance with a prescription given by an appropriate practitioner. If a branded medicinal product is prescribed, then it must be dispensed. A pharmacist who substitutes another product for a branded drug without first agreeing this with the prescriber would be in breach of medicines legislation.

Patient information leaflets include all the relevant information on usage, side effects etc and reflect the information contained in the Summary of Product Characteristics (SPC). The Government have no plans to call for the introduction of a requirement for patient information leaflets to specify the possible risks associated with the use of biosimilar medicines. If a particular risk is identified in relation to a particular product, the SPC for that product will detail that risk and the patient information leaflet will reflect the SPC.