The Opportunity for Biosimilars

Biotherapeutic products have been successful in treating many life-threatening chronic diseases. However, the cost of innovative biotherapeutics has often been prohibitive, thereby limiting their use, particularly in developing countries.

The expiration of the patents and/or data protection for the first major group of originator’s biotherapeutic products such as insulin, human growth hormone and erythropoietin has ushered in an era of products that are designed to be ‘similar’ to an originator product. This is expected to contribute to increased access to these products at an affordable price. Worldwide, the development of similar biotherapeutic products (SBPs) or biosimilars has contributed to reduce the cost of medicines compared to the original biologicals by up to 50%.

ICGEB’s objective is to increase access to biosimilars through fostering internal domestic production capacity in the field of biopharmaceuticals in ICGEB Member States. Our activities aim to contribute to achieving the targets set by the UN Sustainable Development Goals, and in particular SDG3 (Good health and well-being), SDG9 (Industry, innovation and infrastructure) and SDG10 (Reduce inequalities). 

How does it work?

The ICGEB, through a dedicated laboratory, the Biotechnology Development Unit, facilitates the availability of high-quality biotherapeutics at the most affordable price by transferring the know-how for the production and quality control of a dozen of products to industrial partners located in ICGEB Member States. The ICGEB provides a central facility for training in upstream, downstream and quality control operations and transfer of know-how to multiple recipients, and serves as a quality-control laboratory to validate such products for its partners.

The procedure foresees the finalisation of a Technology Transfer Agreement with the industrial partners of the ICGEB that allows for a period of training in ICGEB laboratories and the supply of protocols for the production, purification and quality control of a specific biotherapeutic product. The ICGEB scientists may further provide technical assistance in loco to the industrial partner while reproducing the process on its own premises.

Map showing ICGEB transfers in the field of biotherapeutic products

Available biosimilar technologies

  • Recombinant Human Erythropoietin alpha
  • Recombinant Human Erythropoietin beta
  • Pegylation of Recombinant Human Erythropoietin beta
  • Recombinant Human Interferon alpha 2a
  • Pegylation of Recombinant Human Interferon alpha 2a
  • Recombinant Human Interferon alpha 2b
  • Recombinant Human Granulocyte Colony Stimulating Factor
  • Pegylation of Recombinant Human Granulocyte Colony Stimulating Factor
  • Recombinant Human Insulin
  • Insulin Detemir
  • Recombinant Human Interferon beta 1b
  • Recombinant Human Growth Hormone

For further information
If your Company/ Institute is interested in technology transfer opportunities and training in biotechnology development, technical assistance for product development and Quality Control services (non GMP), please contact: 

Natasa Skoko, Biotechnology Development
Tel: +39-040-3757368, Email: skoko@icgeb.org

Martina Viviani, Technology Transfer
Tel: +39-040-3757365, Email: viviani@icgeb.org