BIOSIMILAR MEDICINE

“Biological medicines have revolutionised patient treatment by offering new and effective medicines for acute and chronic conditions including neutropenia, cancer, a wide range of inflammatory and autoimmune diseases, and enzyme or hormone deficiencies. As the patent expires for individual originator medicines, biosimilar medicines can be introduced to provide additional options for patients and the NHS.

Biosimilar medicines have been used in the NHS for many years as treatments for growth hormone replacement, neutropenia and anaemia related to chronic renal failure or cancer.

A biosimilar medicine is a biological medicine which is highly similar to another biological medicine already licensed for use. It is a biological medicine which has been shown not to have any clinically meaningful differences from the originator biological medicine in terms of quality, safety and efficacy.

Biosimilar medicines are not considered generic equivalents to their originator biological medicine because the two products are similar but not identical. However, they will have met regulatory requirements in terms of comparative quality, safety and efficacy.”

 

Thanks to NHS England for the above text. 

 

The full text can be found by following the link : NHS Biosimilar-guide 2015 

further background can be found by following the link : NHS Biosimilar Medicines

 

Other useful references

Lymphoma Association - biosimilars-lymphoma

BOPA Biosimilar 2005

BOPA Biosimilar-Implimentation Guidelines 2005