Final answer:
A pharmacist may substitute a biological product for a prescribed biological product if certain criteria are met, such as bioequivalence and therapeutic equivalence. This substitution is regulated by specific laws, like the Biologics Price Competition and Innovation Act in the United States.
Step-by-step explanation:
A pharmacist may substitute a biological product for a prescribed biological product if certain criteria are met. The criteria for substitution may vary depending on the country and specific regulations, but generally include factors such as bioequivalence, therapeutic equivalence, and product substitution laws.
For example, in the United States, the Biologics Price Competition and Innovation Act (BPCIA) allows for the substitution of a biosimilar for a reference biological product if the FDA has approved the biosimilar as interchangeable with the reference product. Interchangeable biosimilars have been shown to have no clinically meaningful differences from the reference product in terms of safety, efficacy, and immunogenicity.
It is important to note that while pharmacists are trained to provide information and advice on medication use, they should always consult the prescribing physician or healthcare provider before making any substitutions.