Generics Development

The competition to be the first generic on the market after patent expiry is fierce. Achieving that coveted number one slot is preceded by many years of development work and negotiation with regulatory authorities, and also involves an intricate journey through the complicated patent network. 

We, Sandoz/1A Pharma have built a comprehensive global production and development network with competence centers in all major markets in order to expand our activities beyond standard generics and to promote innovation. Spending on development has increased consistently over the years and, with more than 800 development projects in the pipeline, we have one of the richest pipelines in the industry. 

Generics Quality

With roots dating back more than 120 years and as part of the Novartis Group, Sandoz/1A Pharma 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 Afghanistan.

While generics may differ with respect to their shape, size, or color, 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, full clinical trials are not required in generic development; rather, we establish the drug’s bioequivalence and demonstrate to the FDA and other Health Authorities 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) and European Regulatory Agencies, 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.