The Actavis product portfolio varies greatly between countries. This is due to a number of reasons, including diverse market conditions and differing regulations regarding the approval of pharmaceutical products in the various countries.

In order to get a generic drug approved in the US, companies must submit what is called an Abbreviated New Drug Application or ANDA. In Europe there are four ways to secure approval or market authorisation of pharmaceuticals.

The sale of any Actavis product in a particular country requires approval by the individual country’s national medicines authorities’ agency, a process which can vary depending on the type of drug involved. Products can, for example, be considered:

• Originator/Innovator drugs or Generic drugs
• Prescription bound (Rx) or Over-the-counter (OTC – no prescription required)
• A combination of types – (eg: Rx and Generic)

In many of Actavis’ markets the company’s product portfolio consists mainly of products considered to be prescription bound generic drugs. That means Actavis can usually take an abbreviated route to approval because generic drug applications are not required to include in-depth animal and human clinical data to establish safety and effectiveness in the same way that an originator drug application would have to.

Actavis must, however, demonstrate that its generic products are “bioequivalent” (performs in the same manner) in comparison to originator products. Bioequivalence factors scrutinised by the relevant authorities concern active ingredient(s), quality, safety, dosage forms and strengths, performance characteristics and intended use.