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Frequently Asked Questions

We have collected below the most important and frequently asked question about our business. For further questions, please feel free to contact us and we will endeavor to address your question or comment to the best of our abilities and as quickly as possible.

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• Biosimilars
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1. What are biosimilars?

Biosimilars, or follow-on biologics, are new versions of existing biopharmaceuticals (called reference biopharmaceuticals). They are produced using the same core genetic material and are approved on the basis that they are highly similar to the reference biopharmaceutical product in terms of quality, safety and efficacy.

2. How important are biosimilars?

The real benefit of biosimilars is the introduction of genuine competition into an area that has until now been unhealthily short of it. Competition can help reduce prices; it also helps to free up public funds to broaden overall access to healthcare. In addition, it provides a further incentive for the producers of patent-protected medicines to come up with fresh ideas and genuinely original new products. You could say that competition drives the ‘virtuous circle’ of innovation.

In the next few years, the patents of many major biopharmaceuticals will start to expire, paving the way for biosimilar competition. It is expected that by 2012, nearly half the products approved by FDA will be biopharmaceuticals. In other words, biosimilars are a key future market for companies like Sandoz. (Source: GPhA)

3. Do the terms biosimilars, follow-on proteins, follow-on biologics, biogenerics all mean the same thing?

Biosimilars is the accepted regulatory term in the US and EU for biopharmaceutical products approved via a specific abbreviated regulatory pathway.  In the US, this approval pathway was established in March 2010 with the Patient Protection and Affordable Care Act (PPAC). Follow-on protein products (FOPPs) and follow-on biologics are similar terms. Biologics, or biological medicines, is another term for biopharmaceuticals. Biogenerics is not a generally accepted regulatory term.

4. What are biopharmaceuticals?

Biopharmaceuticals (or biologics) are medicinal substances produced in genetically modified organisms by means of biotechnology. In contrast to “classic” chemically synthesized substances, biotechnologically produced substances are large, complex proteins with molecular weights between 5 000 and 145 000 daltons, in some cases as high as 500 000 daltons. By comparison, aspirin has a molecular weight of 180 daltons. Today, biopharmaceuticals such as recombinant insulin, interferon or erythropoietin are indispensable in practice. Indeed, in many fields there are no real therapeutic alternatives.

5. What is biotechnology?

Biotechnology is the use of the cell’s biochemistry to produce therapeutically useful proteins in significant industrial quantities (scales). Cells from or derived from living organisms are used to produce large and complex protein molecules, often by using recombinant technologies.

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