Frequently Asked Questions
We have collected the most important and frequently asked question about our business. Please note that generics are subject to different legal definitions in different countries. The definition of generics used in this context does not make reference to any particular legal definition.
Select a category
Navigate within ''
- What are biosimilars?
- Biosimilars – an abbreviation of Similar Biological Medicinal Product – are new versions of existing biopharmaceuticals (mostly proteins) whose patents have expired. They are produced using the same core genetic material and are approved on the basis that they are comparable to the reference product in terms of safety and efficacy. They are large, complex molecules produced by living organisms, which are highly sensitive to manufacturing changes. In contrast, generics are small chemical pharmaceuticals and produced by chemical synthesis, usually a very stable process. Biosimilar is an official term used by the European medical authorities; the U.S. terminology is follow-on protein products (FOPP).
The production of biosimilars presents major process challenges in terms of their manufacture, purity, formulation and storage. It is necessary to demonstrate that the biosimilar product’s interaction with the receptor is comparable to that of the reference product. As such, the biological similarity of the two is determined not only in the laboratory, but also in clinical studies, a step not needed for classic generics. - How important are biosimilars?
- In 2010, the patents of many major biopharmaceuticals will start to expire, paving the way for biosimilar competition. It is estimated that by 2010, some 50% of newly approved medicines will be biopharmaceuticals that later on will eventually face patent expiry. In other words, biosimilars are a key future market for companies like Sandoz.
- 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.
- 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.
- What are recombinant technologies?
- Biotechnology can be used to mass-produce essential human proteins, for example insulin. Prior to that, the gene producing the particular protein has to be discovered. In a second step, the gene has to be inserted (recombine it) into rapidly dividing cells, typically a bacterium of some kind. The cells can then produce the relevant protein, which is extracted and purified for therapeutic use.
Navigate within ''
Related content
Pioneering Biosimilars
Sandoz is the pioneer and undisputed global leader in the rapidly emerging market for biosimilars.