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Eric Althoff
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Differentiated generics

Novartis was the first healthcare company to establish a major global presence in both patented and generic pharmaceuticals, and continues to enjoy an unmatched overall leadership position across both segments. It is also the global #1 in biosimilars (off-patent biologics in the combined regions of North America, Europe, Japan and Australia), generic injectables, generic dermatologics, and generic ophthalmics.

Sandoz plays a critical role in the Novartis strategy of offering a range of treatment options to patients, physicians and healthcare providers worldwide. Including generics (and biosimilars) in our portfolio helps make high-quality, affordable medicines available to a greater number of patients.

The Sandoz portfolio focuses on differentiated, off-patent medicines and products that are more difficult to develop, manufacture and market, including:

  • Biosimilars
  • State-of-the-art inhalers
  • Transdermal therapeutic systems, implants and patches
  • Injectables, including oncology injectables
  • Ophthalmics
  • Anti-infectives/antibiotics
  • Dermatologics
  • Immunosuppressants (used in the treatment of rejection in organ transplants)
  • Complex oral solids

Sandoz is the pioneer and global leader in biosimilars – follow-on versions of biopharmaceuticals following loss of patent protection – with three marketed medicines accounting for more than half of the total biosimilar market segment in the US, Canada, EU, Japan and Australia.

  • Human growth hormone Omnitrope
  • Anemia medicine Binocrit
  • Oncology medicine Zarzio

The biopharmaceutical field is an excellent example of how Sandoz collaborates with other Novartis divisions, leveraging expertise in modeling, simulation and therapeutic areas (particularly oncology), and sharing analytical platforms.

The benefits of biosimilars

The introduction of biosimilars in the EU has already led to significant savings for patients and payors. The latest study by the IGES Institute in Berlin estimates that healthcare systems in eight EU countries can save up to EUR 33 billion by 2020 through the introduction of biosimilars.

The number of therapeutic areas covered by biosimilars is expected to increase steadily over the next decade.

Biosimilar development requires substantial time and investment. A typical biosimilar takes seven to eight years to develop, at a cost of between USD 100 million and USD 250 million.

For a small-molecule generic, by comparison, development could take two to three years, at a cost of USD 2-3 million.

Effective biosimilar development has to manage opposing needs: speed-to-market on the one hand and cost-effectiveness on the other. At Sandoz, this is a two-step process: first, guaranteeing a high level of molecular similarity to the reference product, then driving commercial viability through appropriate clinical tests to ensure a broad clinical label.

Navigating the regulatory pathway to ensure speed to market

The FDA's review of one particular Sandoz generic - which took five years from the time of filing - set important precedents for generic versions of large complex molecules that reside on the border of traditional drugs and biologics. The generic is a complex, heterogeneous mixture of sugar molecules derived from heparin. Sandoz and its collaboration partner Momenta Pharmaceuticals Inc., from Cambridge, Massachusetts, invested heavily in development of state-of-the-art analytical methods to clearly demonstrate equivalence of the Sandoz generic to the branded competitor product.

By designating the Sandoz generic equivalent to the reference product, the FDA paved the way for automatic pharmacy-level generic substitution of the product across the country.

Sandoz was also the first company to win approval for a generic version of an inhaled respiratory medicine, under new guidelines adopted by the European Union for orally inhaled products. Skillful navigation of the regulatory pathway gives Sandoz a competitive edge as it expands its respiratory franchise. Respiratory is another pillar of the Sandoz differentiated products strategy, complementing biosimilars and generic injectables, dermatology and ophthalmics.

The future of healthcare relies on affordable, high-quality generics and differentiated products such as biopharmaceuticals. Sandoz is working intensively to meet the ever-growing demand for these cutting-edge medicines and to further increase patient access to high-quality, affordable, healthcare.