The evolution of biosimilar pharmaceuticals

Kundl – Austria, 24 September 2014 – Today, notwithstanding continuing research into these new weapons in the fight against disease, the first generation of biological drugs on the market has exceeded the patent deadline.

The loss of patent coverage has allowed so-called ‘biosimilar drugs’ to enter the therapeutics market. These are drugs that are similar to the original biological drugs which can be produced and commercialised at lower prices due to the decreased spend on research.

Biological drugs, developed through modern biotechnology, have aided in the treatment of inflammatory, autoimmune, neuro-degenerative and renal diseases, growth disorders and tumours for several years. These drugs consist of more complicated molecules that require more difficult and expensive studies to develop. They are effectively drugs that are produced and obtained from living organisms like bacteria and cells. In contrast to traditional drugs that are produced chemically, and are therefore easily replicated if the formula is available, biological drugs cannot be exactly replicated if a different producer bacterium, different procedure or location is changed.

Biosimilar drugs are, therefore, biological medicines that are similar to a biological agent that is already on the market and has an expired patent.

Authorisation to enter the market is given by the European Medicines Agency – EMA – and is given when a drug’s quality, efficiency and safety are verified. The development and use of biosimilar drugs represent a big opportunity to improve the efficiency of health and support systems given their potential to satisfy a growing need for efficiency, bespoke therapies and safety in healthcare. Biosimilar drugs are also an essential instrument for building a free-enterprise drugs industry that is competitive which is necessary in a sustainable healthcare system, and in the field of innovative therapies that maintains safety and quality guarantees for patients. This gives them equal and timely access to innovative drugs in a wider context of reduced public spending.

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