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Biotechnology and Biological Products

The UK Biotechnology and Biological market is widely recognised as one of the most advanced in the world with almost twice as many products in development compared to any other European country.

Biotechnology and Biological Products are recognised as follows:

  • Biotechnology Products are manufactured by using recombinant DNA technology (genetic manipulation of cells) or a monoclonal antibody.
  • Biological Products are defined as such because they are difficult to characterise or control as compared to standard pharmaceuticals.

The European Medicines Agency (EMA) defines a biological medicinal product as “a medicinal product whose active substance is made by or derived from a living organism.”

The two largest groups of biologicals are:

  • blood products
  • vaccines

Other products include:

  • hormones
  • larger peptides
  • tissue derived products

When biologics go off patent there is the opportunity for manufacturers to create a ‘biosimilar’.  More information can be found under the ‘biosimilars’ section.

Please refer to our biotechnology services for further information or contact us to discuss your specific regulatory compliance requirements.