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), generic injectables 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 affordable, high-quality medicines available to a greater number of patients.
The Sandoz portfolio focuses on differentiated, off-patent medicines that are more difficult to develop, manufacture and market, including:
- State-of-the-art inhalers
- High-tech patches & implants
- Complex oral solids
Sandoz is the pioneer and global leader in biosimilars - follow-on versions of biopharmaceuticals following patent expiry - with three marketed medicines accounting for approximately half of the total biosimilar market segment in the combined markets of North America, Europe, Japan and Australia.
- Human growth hormone Omnitrope
- Anemia medicine Binocrit / epoetin alfa Hexal
- Oncology medicine Zarzio / filgrastim Hexal
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 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 75 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 free 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. Skilful navigation of the regulatory pathway gives Sandoz a competitive edge as it expands its respiratory franchise. Respiratory is the third pillar of the Sandoz differentiated generics strategy, complementing biosimilars, injectables and opthalmics.
The future of healthcare relies on affordable, high quality generics and differentiated products - particularly biopharmaceuticals. Sandoz is working intensively to meet the ever growing demand for these cutting-edge medicines and to further increase patient access to affordable, high-quality healthcare.