More than five years after it first sought regulatory approval, Teva Pharmaceutical Industries has become the first company to launch a biosimilar drug in SA. The drug, its version of Amgen’s filgrastim, is used to boost white blood cell production in cancer patients undergoing chemotherapy. It is marketed and distributed in SA by Cipla-Medpro, a wholly owned subsidiary of the Indian generic manufacturer Cipla. While the development demonstrates the capacity of the South African Health Products Regulatory Authority (Sahpra) to assess the safety and efficacy of biosimilars, it also highlights the extensive delays drug manufacturers face in getting their products approved. Biosimilars are copies of biologic medicines, which contain a living organism or a derivative of one. These types of medicines appear to be taking even longer to register than generics. A typical generic approval takes 18 to 24 months, Cipla Medpro CEO Paul Miller said. Sahpra’s acting CEO, Portia Nkambule, said the...
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