The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guideline on the naming of medicinal products. MHRA’s most substantive change is the addition of a new section that provides general recommendations for brand naming and prescribing.
In some cases, products are approved for use and subsequently prescribed by brand name alone. The updated MHRA guideline details factors it will consider when assessing if this is the right approach for a particular product, as well as the additional steps manufacturers may need to take when their products are approved with a brand or generic name.
The situation is most straightforward for biologics and biosimilars. MHRA will only approve these products with brand names so it can differentiate between safety reports filed about biologics and their biosimilar copies. The UK may change that rule once it has more data on biosimilar switching.
Multiple factors dictate whether a small molecule product will be approved only by brand name. In the guideline, MHRA states it will consider whether the therapeutic index of a drug raises the risk of toxicity and the severity of the clinical consequences of toxicity when making assessments about the use of brand names…