Generic veterinary medicines
Generic veterinary medicines emanate from the same molecule as the originator. They are equally high quality, safe and efficient as the originators. Generics are thoroughly assessed, authorised and regulated by the competent authorities before entering the market. They need to comply with the stringent quality, safety and efficacy requirements for the animal, human health and the environment. To operate in Europe, the generic producers also have to follow rigorous manufacturing standards and quality controls known as good manufacturing practice (GMP).
Generic medicines are authorised and placed on the market after intellectual property and other protection periods associated to the originator product have expired. This may take up to 25 years. When entering the market, generics will be produced with up-to-date technology, enhanced analytical capacities and materials complying with the most recent regulations.
- For veterinarians and animal owners
Generics are used as effective treatment alternatives to high-priced originator products especially in lifelong treatments of companion animals. They also contribute to safe farming practices in many geographic regions where the cost of originator medicines might not be affordable.
The generics are an innovative business branch that develops optimised medicines with an added value compared to the existing ones. Generic companies often develop equivalent or even new formulations to target other indications or species. The products may also bring added value with improved features, such as easier usage and more accurate dosage. Being more affordable, generics enable access to animal health for all, regardless of income or size of the market.
- For society
Allowing effective competition between generic and original veterinary medicines is crucial for providing affordable choices to society and incentivise innovation. Generics help to solve availability problems by increasing the range of existing choices. They are available to wider, including minor markets.
Many of the generic companies are small and medium-sized companies. They are able to reach markets that are not considered by the bigger players. Generics facilitate the appropriate use of medicines when there is no originator available or the price of the originator cannot be afforded.
By increasing the range of existing choices, the generic industry enhances availability as medicines become accessible to more users and more geographical regions.
- Availability
Generics are present in every EU member state, across all therapeutic areas and for a wide range of different species – both major and minor species. They help to fill gaps in markets where originators are not present (mainly smaller markets), or for species and indications where there is no originator medicine available.
- Convenience
Many generics contain improvements in presentation, taste or physical properties, making them easier to administer and better dosed to the animal.
- Compliance
By widening the range of available medicines to more species and indications, the generic veterinary industry enables better treatment rates across Europe. The improved features also enhance and facilitate adherence to therapies increasing animal welfare.
- Efficacy
Generics are proved to be effective according to strict requirements and have a demonstrated bioequivalence with the originator products. They are equally efficient as the reference product and in addition, may include new therapeutic indications.
- Safety
Due to their late arrival, generics are authorised according to the most recent rigorous safety requirements and quality controls. Improved formulations and more suitable and better adapted features provide advantages without compromising the safety of the product to the animals, end users, public health and the environment.
- Savings
Generics stimulate a healthy competitive environment. The introduction of one or several generics will, in most cases, lead to a price decrease in that market segment.
Market study 2021
Generic and added value veterinary product market in Europe
Market study 2019
Assessment of the generic veterinary product market in Europe