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Regulatory interchangeability designation in the US

Extrapolation is the scientific and regulatory process of granting a clinical indication to a medicine without conducting a separate clinical efficacy and safety study.

A biosimilar should have the same label as the reference medicine.

Under the guidance of a physician, a patient can be switched.

A biosimilar and the reference medicine have the same active ingredient.

Physicians can safely guide the switch from a reference medicine to a biosimilar.

Manufacturers of innovator and biosimilar medicines should have equal opportunities to secure treatment volumes based on the overall value of the medicine for patients and the health care systems.

Novartis is deploying a mix of access models covering infectious and noncommunicable diseases. Our approaches are tailored to the different local needs.

In recent years, noncommunicable diseases (NCDs) such as cardiovascular diseases, diabetes, respiratory diseases and cancers have become an emerging pandemic globally with disproportionately higher rates in developing countries.