Generics

A generic medicine is a medicine which is known by its 'generic' name rather than by its 'brand' name.  It contains the same active ingredient and has the same therapeutic effect on patients as the original medicine which is no longer patent protected (patents typically last for 20 years). 

They can contain different non-active ingredients (e.g. colourings) and may be a different size and shape to the original product but none of these differences will have an impact on the therapeutic effect.  To obtain market approval, the generic must be "bioequivalent" to the original product (the ‘reference’ medicine) and comply with the same standards of quality, safety and efficacy.  Therefore, a generic will contain the same active substance(s) as the reference medicine, and will be used at the same dose(s) to treat the same disease(s) as the reference medicine.

A generic medicine can be identified either by its Internationally approved Non-proprietary scientific Name (INN) or by its own brand name.

Generic medicines are popular with organisations such as the National Health Service (NHS) because they are significantly cheaper than their brand-name equivalents (costing 20-90% less) and the generic manufacturers avoid the risks and costs associated with the research and development involved in innovative medicines.  There are many pharmaceutical companies which focus on the manufacturing and licensing of generic medicines.

It is important that generic medicines continue to be provided as they can save healthcare systems billions throughout the world.  In June 2015 the IMS Institute for Healthcare Informatics published their report “The Role of Generic Medicines in Sustaining Healthcare Systems: A European Perspective”.  One of the report’s findings is that European payers saved an estimated €100Bn in 2014.  Without generics, healthcare systems would become financially unsustainable.

Please refer to our regulatory services for further information.

Please contact us with your specific regulatory compliance requirements.  We look forward to working with you.