With roots dating back more than 120 years and as a division of Novartis, Sandoz is a trusted leader with a reputation for exceptional quality. Our core business lies in developing, producing, and distributing high-quality medicines following the loss of their respective patent protection, thus helping secure access to affordable, quality healthcare for patients in the US.
While generics may differ with respect to their shape, size, or color, they contain the same active ingredients as the original product and are therapeutically equivalent to and substitutable for the brand product.
Since generic medicines contain the same active ingredients as the brand product, full clinical trials are not required in generic development; rather, we establish the drug’s bioequivalence and demonstrate to the FDA that equivalent dosing 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 US Food and Drug Administration (FDA) both prior to and post product approval. Production facilities are thus regularly inspected to ensure that they are cGMP (current Good Manufacturing Practice) compliant, while marketed products are regularly monitored to ensure the highest quality standards.
Our global portfolio comprises approximately 1,000 molecules, covering all a wide range of major therapeutic areas. Our products reach approximately 500 million patients every year. Our broad portfolio is spearheaded by our global leadership positions in both biosimilars, the “cutting edge” of innovative off-patent medicines, and generic antibiotics, the backbone of global healthcare systems.
Our broad offering translates into substantial and ongoing savings for patients and payors, which help to ensure the sustainability of healthcare systems in the face of significant budgetary pressures, while also freeing up funding for innovative medicines.
At Sandoz, we make far more than just traditional generic medicines. Sandoz offers a variety of drug delivery mechanisms. These include:
- Inhalables – used in the treatment of asthma and COPD, inhalables combine complex drugs with sophisticated medical devices
- Injectables – non-biologic drugs taken via injection, which follow a parenteral route of administration. They are the cornerstone of modern hospital treatment and most typically include intradermal, subcutaneous, intramuscular and intravenous methods of application.
- Oral solids – tablets or capsules; can be extended or slow release
- Oral films – particularly effective for patients who need fast acting treatment or who have difficulties swallowing oral medications
- Transdermal patches – an innovative alternative for controlled drug delivery through the skin and into the bloodstream