More than five years after it first sought regulatory approval, Teva Pharmaceutical Industries has become the first company to launch a biosimilar drug in South Africa, reports Business Day. 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 South Africa 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, the report says.
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 delay in registering Teva’s biosimilar was due to the backlog of products awaiting scrutiny. Sahpra had received three other dossiers for biosimilar filgrastim products, she said.
The report says Filgrastim Teva will be 30% cheaper than Amgen’s Neupogen, opening the way for more cancer patients to access the treatment, Miller said. A pack of five 300 microgram injections of Filgrastim Teva will cost R3,794.76 (including VAT), compared to Neupogen, which costs R5,421.09, he said. “As volumes increase, we would look to reduce the price further,” Miller said.
Filgrastim is used to counter one of the major side-effects of chemotherapy drugs, which can disrupt the production of a type of white blood cells in the bone marrow known as neutrophils. A reduction in neutrophils causes neutropenia and hampers the patient’s ability to fight off infection. Filgrastim stimulates bone marrow to produce new white blood cells and reduces the duration of neutropenia.
Miller said that patients with neutropenia frequently experienced painful infections of the mouth, skin and genital tract, making it hard to endure chemotherapy. If more patients had access to affordable treatment, they would find it easier to stick with their chemotherapy regime, he said.
The report says the Cancer Alliance’s Salomé Meyer welcomed the launch of Filgrastim Teva, but said it remained too costly. “It is an old medicine and warrants a much bigger reduction in price. A 50% reduction would have put patients in a better position to access it. We need an era where cancer medicines are affordable to our patients,” she said.
Filgrastim was approved by the US Food and Drug Administration in 1991 and the FDA announced that it has now approved its second biosimilar for the drug, Pfizer’s Nivestym. It gave Sandoz’s version of filgrastim, Zarxion, the green light in 2015.
The Cancer Alliance had asked Sahpra to expedite the approval of cancer medicines, Meyer said. The alliance hoped the next one would be a biosimilar for Roche’s breast cancer drug trastuzumab, known as Herceptin, she said. The launch of biosimilar versions of trastuzumab should drive competition and lower the price of treatment, she said. Many private sector patients could not afford trastuzumab, as a significant number of medical schemes did not pay for it, Meyer said.
Miller said in the report that Cipla Medpro had submitted a dossier for a trastuzumab biosimilar, but had yet to receive an answer from Sahpra. Cipla Medpro was finalising three more dossiers for biosimilars, while Teva was seeking approval for a portfolio of biosimilars for cancer, rheumatoid arthritis, multiple sclerosis, diabetes and anaemia, he said.Business Day report