FAQ

General / market: * Generics are subject to different legal definitions in different countries. The definition of generics as used in this context does not make reference to any particular legal definition.

  • What is biotechnology?
    Biotechnology is man’s use of the cell’s chemistry to produce therapeutically useful proteins in significant industrial quantities. Cells from or derived from living organisms are used to produce large and complex protein molecules, often using so-called recombinant technologies.07-12-2007
  • What are recombinant technologies?
    Biotechnology can be used to mass-produce essential human proteins, for example insulin. What you have to do is discover the gene responsible for producing the particular protein, then insert that gene (recombine it) in 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.07-12-2007
  • What is the difference between biosimilars and generics?
    To put it simply: biosimilars are large, complex molecules produced by living organisms, which are highly sensitive to manufacturing changes; generics are small molecules, produced by chemical synthesis, which are usually very stable.07-12-2007
  • What are all these other terms – biologics, follow-on-proteins, biogenerics?
    Biosimilars is the accepted regulatory term in the EU; follow-on-protein products (FOPPs) is the equivalent term in the US. Biologics, or biological medicines, is another term for biopharmaceuticals. Biogenerics is not an accepted regulatory term.07-12-2007
  • Are biosimilars the same as the reference product?
    Biosimilars are not chemically identical to the reference product in the same way as generics – they are produced by living organisms, not by chemical synthesis. However, they are products that have been demonstrated to the satisfaction of the regulator to be comparable to the reference product in terms of quality, safety and efficacy.07-12-2007
  • Is the regulation procedure similar?
    Biosimilars are approved in the EU through an abbreviated registration process based on strict guidelines. Prior to this, they undergo an extensive development process, including pre-clinical and clinical trials to confirm both safety and efficacy. These trials are not required for traditional generics. 07-12-2007
  • What are the differences in the development process for biosimilars and generics?
    There are major differences, with unique requirements for biosimilars at all three stages (technical, non-clinical and clinical development). These include design specification, special analytics, extensive pre-clinical work and more clinical trial requirements.
    07-12-2007
  • Do biosimilars take longer to develop?
    The difference is currently considerable. Biosimilars can take more than twice as long to develop as generics.07-12-2007
  • What is the legislative position?
    A legislative pathway already exists in the EU – thanks largely to the efforts of Sandoz, which received the first ever approval for a biosimilar medicine in 2006 (Omnitrope®, an approved version of somatropin, or human growth hormone). Omnitrope® has also been approved in the US, but under an existing procedure. A specific US legislative pathway for biosimilars, similar to the European one, is still being defined.07-12-2007
  • Sandoz has pioneered the field of biosimilars. How many biosimilars do you already have on the market?
    Since approval of Omnitrope®, Sandoz has received EU approval for a second product – Binocrit®, the first complex biosimilar on the market. This is a version of epoetin alfa, a medicine which is already marketed under various brand names to regulate the formation of red blood cells. More than 250 000 patients in Europe are estimated to be treated with epoetin alfa and similar medicines.
    07-12-2007