Quality Generic Medicines - Introduction
Dating back more than 125 years and as part of the Novartis Group, Sandoz is a trusted leader with a reputation for quality. Our core business lies in developing, producing and distributing high-quality medicines following loss of their respective patent protection, thus helping secure access to affordable, quality healthcare for patients worldwide.
While generics may differ with respect to their shape, size or colour, they contain the same active substances as the originator product and are therapeutically equivalent to and thus substitutable for the reference brand product. Given this same active ingredient where full clinical trials are not required in generic development; it is the drug’s bioequivalence that needs to be established, demonstrating that equivalent dosing essentially has the same effects within the human body as the reference product.
Generic medicines also offer the same quality and safety profiles as reference products. Throughout their development and production processes, generics are required to adhere to the same rigorous standards of quality, safety and efficacy as originator products, standards that are closely monitored and enforced by the relevant regulatory authorities both prior to and post product approval. Production plants are thus regularly inspected to ensure that they are and remain cGMP (current Good Manufacturing Practice) compliant, while marketed products are regularly monitored to ensure continuous quality standards are met.