What Does the Vet Say? - March 2025

BC: We hear about generic and pioneer medicines – what are the differences?

RM: A pioneer veterinary medicine is the first drug that contains a specific active ingredient approved by the Health Products Regulatory Authority (HPRA) or the European Medicines Agency (EMA) for its particular use and is often referred to as the ‘brand product’.
A generic medicine is developed to be the same as a medicine that has already been authorised, it is called the reference medicine.
A generic medicine contains the same active substance or substances as the reference medicine, and it is used at the same dose or doses, same route of administration and for the same indications. However, a generic medicine’s inactive ingredients, name, appearance and packaging can be different.

BC: Is there a difference in quality?

RM: There is no distinction between ‘generics’ and ‘non generics’ when it comes to the standards applied for quality and approval processes. Generic medicines are manufactured according to the same strict quality standards as all other medicines.
In order to become licensed (also known as obtaining a marketing authorisation), generic medicines undergo a rigorous authorisation process to ensure the product is safe, efficacious and of a high quality.
Critically, generic medicines must be proven to be bioequivalent, which means they will be therapeutically indistinguishable and therefore interchangeable in a clinical setting.
Both pioneer and generic medicines are subject to the same ongoing requirements when on sale such as on-going stability testing. To operate in Europe, the generic producers have to follow manufacturing standards and quality controls known as good manufacturing practice (GMP).

BC: If they look the same and they work the same, why should a farmer distinguish between them?

RM: The availability of generic medicines increases competition within the market, when generally results in more cost-effective solutions becoming available to farmers.
It also means that should one manufacturer experience manufacturing or stock issues, alternative products, suitable for the same treatment, will remain available to ensure the welfare and productivity of our livestock.
While generic medicines have the same active ingredient, they may differ in other beneficial ways such as pack sizes, ease of application or use of safer excipients. Essentially, farmers benefit from the same high-quality standards but may benefit from favourable pricing. It’s natural to be loyal to the brands we have always used, but it can be worth asking your veterinarian or advisor if there is a newer, generic version, which might have a lower price or other benefits.

BC: Are generics readily available everywhere?

RM: Yes, generic veterinary medicines are available from all licensed retailers of veterinary medicines. Ask your prescriber for further advice.

BC:What challenges exist for generic medicine market development?

RM: Regulation (EU) 2019/6 is a set of rules that govern the use of veterinary medicines in the European Union. The regulation was introduced with the aim of increasing the availability of veterinary medicinal products and supporting innovation as well as reducing the rate of development of antibiotic resistance.
In theory, it should have reduced the administrative burden on companies and stimulated innovation. While it has improved harmonisation, it has also introduced notable financial and administrative burdens, particularly for small and medium-sized enterprises (SMEs).