FIP issues biologics policy

PHARMACISTS’ dispensing expertise that enables them to substitute generic medicines for different brands qualifies them to substitute biosimilar medicines as well, according to a statement by the International Pharmaceutical Federation (FIP).

The Federation has published a revised Statement of Policy on “Pharmacists’ authority in pharmaceutical product selection: Therapeutic interchange and substitution”.

The policy update now covers the introduction of biologicals and their biosimilars into the market.

In addition, the FIP calls for pharmacists to be provided with bioavailability data by regulatory authorities and manufacturers.

The revision also recommends that, to ensure safety, information about excipients should be taken into account when making decisions on substitution.

“To date, no major safety issues with the use of biosimilars as alternatives to the original biological medicine have been reported,” the statement says.

A significant recommended condition for the substitution of a biologic medicine is that it should only be allowed with a product containing a different active ingredient when there is consent from the prescriber.

The statement of policy also calls for “adequate pharmacovigilence to ensure identification of a biological medicine should any product-specific safety (or immunogenicity) concerns arise, as well as for post-marketing safety studies by companies marketing generic medicines or biosimilars, with safety updates to be made publicly accessible”.

“The purpose of this policy is to guarantee quality and good pharmacy practice,” said FIP vice president Eeva Teräsalmi.