Biosimilars

Biological drugs have been used since 1980 to treat a whole range of serious diseases – such as cancer, autoimmune diseases and diabetes. These biological drugs, also called biologics, are highly complex. Due to the extensive research and development process, the costs of biologics can quickly go into the millions. Biosimilars were developed to facilitate patient access to these important treatment options despite this. A biosimilar is, just like the biologic therapy, a biotechnologically manufactured drug, which is comparable with an already approved biological drug, the "reference product". As a result, biosimilars are more affordable with the same effect since the research costs are lower.




* Note: In Switzerland, Swissmedic is responsible for the authorisation of medicinal products. Source: Progenerika e.V


Biosimilars are significantly more affordable than their reference biologics.

Biosimilars are just as high quality, safe and effective as their reference biologics.

Biosimilars provide an important social contribution to global healthcare provision by making expensive treatments more accessible.

Frequently asked questions and answers on biosimilars

  • What are biosimilars?

    What are biosimilars?

    A biosimilar is a biological drug that is very similar to the reference product with regard to quality characteristics, biological activity, safety and efficacy.

    Since biosimilars are produced with living organisms, non-substantial differences may exist versus the reference product. These differences are not clinically significant, meaning no differences are expected in terms of safety and efficacy.

    All biological drugs are subject to natural fluctuations. Strict controls are performed to ensure that the efficacy or safety of the drugs is not impaired.

    Both the original reference products and the biosimilars are manufactured under strictly controlled conditions to ensure that they meet quality standards, as required by good manufacturing practice (GMP).

  • Can access to treatments be increased thanks to biosimilars?

    Biosimilars offer doctors and patients important therapy options, expand access to life-saving and life-enhancing treatments and support healthcare professionals in coping with growing financial pressure.

    Innovation in medicine is crucial when we expand patient access to key treatments and want to ensure the sustainable future of our healthcare provision. Biosimilars support this and are an exciting and important addition to the healthcare landscape.

    In France, Germany, Italy and Great Britain, biosimilars enabled increased patient access to treatment by 44% from 2006 to 2014.

  • Can healthcare costs in Switzerland be reduced using biosimilars?

    Biosimilars offer a clear price saving over the respective comparator products from original manufacturers. At market entry, biosimilars are at least 25% cheaper than the corresponding previously patent-protected reference product.

    With the increasing spread of biosimilars, it is also realistic for Switzerland to make savings in the triple-digit millions.

  • How can Mylan be the expert in generic drugs and innovative biosimilars?

    Mylan has been producing high-quality drugs for nearly 60 years in order to meet the needs of patients and specialists throughout the world.

    Mylan has advanced the development of antiretroviral agents, introduced innovative new therapies and continuously delivers high-quality and effective drugs to treat some of the world's most challenging diseases. Mylan’s many years of experience and ability to develop, manufacture, and successfully market complex products globally has made Mylan a leading global provider of biosimilars.

    Mylan’s commitment to allow expanded patient access to treatment throughout the entire world is shown in the extensive biosimilars portfolio.

  • How are biosimilars registered?

    Biosimilars are extensively tested for their comparability with their reference products. The scope of these comparability tests is defined on a case-by-case basis for each individual biosimilar in close cooperation with the regulatory authority.

    In the development of biosimilars, the latest analytical and biotechnological methods are used, including some methods which may not have been available at the time of the reference product’s initial approval.

    In contrast to the reference product, whose approval is based mainly on clinical trials, the approval procedure for a biosimilar places emphasis on comparative analytical studies:

  • Are biosimilars and their reference products interchangeable?

    As part of the approval process, the authorities in the EU and Switzerland require sufficient homology of reference product and biosimilar with regard to efficacy and safety. Neither the EMA nor Swissmedic require evidence for the interchangeability of reference product and biosimilar for its approval and also do not provide any recommendation for handling in practice.

    The doctor is responsible for the prescription. Automatic substitution at pharmacy level is not permitted.

Last Updated:  12/05/2020