The biosimilar G-CSF is just as tolerable, effective and safe as the ‘originator’ G-CSF in all indications, according to a review of the literature by German haematologists.
Writing in Current Opinion in Hematology the doctors said that no evidence of immunogenicity has emerged nor have seven years of copious use in Europe raised any other concerns about long-term safety.
G-CSF is an ideal starting point for developing biosimilar products, given its relatively simple structure and straightforward manufacturing process.
In addition, G-CSF can be tested safely in healthy volunteers, changes in blood counts give a rapid and simple assessment of its pharmacodynamics, and the mechanism of action is well understood.
“On the clinical side, little excitement is tangible, probably appropriately so, since clinical data indicate nothing short of biological similarity,” they wrote.
However from a financial perspective access to six biosimilar G-CSF products Europe dropped the unit price by as much as 80%, vastly exceeding the predicted saving of 25-30%, and overall cost savings have persisted despite an annual 5% increase in use.
While these short-term savings are appealing, the effects on the broader biosimilar industry are more complex and overall cost savings cannot be guaranteed, they said.
For example, establishment costs for producing a biosimilar are very high, even though the original research has already been done, so they are likely to be limited to ‘blockbuster’ medicines.
“Costs for the multitude of niche biologicals will be maintained if not increased to compensate for lost income with products with biosimilar competition,” they said.
Developers of the original product will try to develop ‘biobetters’ with new patents and higher costs, eroding potential savings.
Australia has also benefited from the approval of G-CSF biosimilars, and the US FDA finally granted approval in 2015.