One of the challenges posed to regulators will be the naming requirements for biosimilars. In order for physicians to select the most appropriate biosimilar medicinal product and also for pharmacovigilance purposes, the question has been asked as to what proprietary and/or non-proprietary name should be permitted for use on biosimilar products.
When is a medicine not a medicine?
The vast majority of human medicines are easily identifiable as such and are therefore subject to the European Commission marketing authorisation procedures. There are however, some products which are not so easily categorised such as cosmetic products and food supplements. These products are referred to as borderline products.
Borderline substances are mainly foodstuffs, such as enteral feeds and foods that are specially formulated for people with medical conditions, but also include some toiletries, such as sun blocks for use by people with conditions such as photodermatosis. Whenever a product contains a pharmacologically active substance or makes medicinal claims then it falls into the definition of a medicinal product and as such will be subjected to medicines control. An example of this would be toothpaste; whilst ordinary toothpaste would be considered cosmetic, if the toothpaste were to claim to cure sensitive teeth and contains an active substance that causes that effect then it will become subject to medicines control.
Movement towards a single EU-wide authorisation
It was announced at the TOPRA 7th Annual Veterinary Medicines Symposium in Dublin in 2012 that significant changes would be made to the current Veterinary Medicines legislation (Veterinary Medicines Directive).
Four main problems were identified by industry:
- High administrative burdens
- Lack of availability of veterinary medicines
- Risk of antimicrobial resistance
- Deficient operation of single market
Historically, there have been relatively few clinical studies on how medicines affected children in Europe and what the prescribing dose should be. This was in part due to children making up a smaller percentage of the patient population as well as it being seen as unethical to conduct clinical trials on children.
With no clear guidance for the pharmaceutical industry, this resulted in fewer medicines being available for children who required treatment; therefore children were often prescribed medicinal products off-label i.e. being given medicines for unapproved indications or age groups. Recognised by the industry as unsuitable and unsafe, new regulations and guidelines were brought out to help address this issue.
To obtain global marketing approval for any pharmaceutical product (whether intended for animal/human use) one of the key documents required is a Certificate of Pharmaceutical Product (CPP), which has been recommended by the World Health Organisation (WHO).