The Medicines Control Council has approved the country’s first biosimilar, a copy of Amgen’s drug filgrastim made by Teva Pharmaceuticals.

The drug stimulates bone marrow to make new white blood cells and is used in some patients undergoing chemotherapy. The development has been welcomed by cancer advocates, who say it will pave the way for other biosimilars that are in the pipeline, boosting competition and driving down prices.

They are particularly keen to see biosimilars approved for Roche’s breast cancer drug trastuzumab, branded Herceptin, and its blood cancer drug rituximab, branded MabThera. Biosimilars are copies of biologic medicines that contain a living organism or a derivative of one.

"This is a proud moment for the Medicines Control Council and demonstrates the capacity of its experts and secretariat to assess the complex data that have to be considered when making a decision on the comparability of a biosimilar medicine," said council chairwoman Helen Rees.

Teva’s biosimilar filgrastim was expected to be cheaper than Amgen’s version, which is branded Neupogem, said Salomé Meyer of the Cancer Alliance. A single 300mg injection of Neupogem cost R1,493 in the private sector and R464 in the state sector, she said.

Patients in the private sector would have a savings on their total oncology expense, while the public sector would be able to add the cost saving to their total budget available to treat patients, she said.

Teva’s products are marketed in SA by Cipla-Medpro, wholly owned by Indian generic drug manufacturer Cipla. Cipla-Medpro CEO Paul Miller was not available for comment.


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