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WHAT IS Biosimilars:

Unlike generic chemical medicines where the active ingredients are identical, biosimilars – by definition – are not likely to be identical to the originator biologic. They are highly similar, but not the same.

Biosimilars made by different manufacturers differ from the original product and from each other. 
Biosimilars are not expected to be direct copies of originator biologics and are therefore not the same as generic drugs. Due to the complex structure of biologic medicines and the processes involved in production, biosimilars must be shown on the basis of analytical, non-clinical and clinical data to be similar to an original biologic in terms of structural characteristics, and safety and efficacy. Minor differences with the active ingredient are expected and permitted so long as any such differences are demonstrated not to be clinically meaningful. The patents of a growing number of biologic medicines have already expired or are due to expire, which has led to an increased interest in the development of biosimilars.

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Defining Biosimilars:

The World Health Organization: A biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product.

The European Medicines Agency: A biological medicine that is developed to be similar to an existing biological medicine (the ‘reference medicine’). When approved, a biosimilar’s variability and any differences between it and its reference medicine will have been shown not to affect safety or effectiveness.

The U.S. Food and Drug Administration: A biological product that is highly similar to a U.S. licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity and potency of the product.

Taj Oncology Biosimilars:

  • Biosimilars are potential therapeutic alternatives for biologic medicines, and offer the potential for increased access and reduced cost.
  • Amgen is a pioneer in the field of biologic medicines. Science-based medicine and patient safety are fundamental to our values.
  • Amgen is uniquely equipped to leverage its leading position in biotechnology to produce biosimilars. We currently have six biosimilar molecules in development. We expect to launch the portfolio starting in 2017. 
  • Amgen’s core business and growth strategy remains focused on discovering, developing and delivering innovative medicines for patients with grievous illness. 

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