Blood Cell Booster
After a previous attempt failed three years ago, the US Food & Drug Administration (FDA) has approved Novartis’ Ziextenzo, a biosimilar version of Amgen’s Neulasta, for use in enhancing the infection-fighting white blood cells of cancer patients during chemotherapy. Novartis hopes to launch the drug this year, according to John Miller of Reuters.
Novartis, which is based in Switzerland, has been battling to sell copies of rivals’ blockbusters in the world’s top drug market. Neulasta has achieved $4 billion in sales. Ziextenzo was rejected by the FDA in 2016. That demonstrated the challenges that manufacturers of less expensive copies of significant biological medicines face in the United States, compared to the positive reception they have received in Europe. Because the FDA rejected Ziextenzo in 2016, Coherus BioSciences and Mylan beat Novartis to the US market with their own copies of Neulasta.
Carol Lynch, president of Novartis’s Sandoz generics division that makes biosimilars, said, “The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option.” She explained that biosimilars are near-copies of brand-name drugs. Because they are biological medicines, they cannot be exactly replicated. Studies have demonstrated that biosimilars they have the same efficacy for patients as the original drugs.
Novartis, which resubmitted the application in April, did not comment on why the original one was rejected. Its name is an example of drugmakers using the letters “Z” and “X” in drug names to grab attention.
Coherus’s and Mylan’s Neulasta copies, with initial prices at discounts of about 33 percent, have impacted Amgen’s business. Neulasta witnessed a 32-percent decline in sales in the third quarter of 2019, a trend Novartis is hoping to accelerate now that it has joined the group of companies competing with Amgen.
Novartis has eight biosimilars on the market in Europe, including Ziextenso Thus far, it only has four US approvals, pointing out the big differences in the two markets. In Europe, biosimilars have made substantial gains as governments and insurers use them in order to save money.
In the US, the cheaper copies are not getting approved quickly, even though there is a demand to cut high drug prices> Drug projects in the US encounter delays as a result of patent lawsuits and regulatory issues, as well as tactics by manufacturers of the original drugs attempting to maintain their market share.
Ziextenzo, used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), a common side effect of cancer treatment that can leave patients vulnerable to infections, is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever). The drug is not intended for use in patients with the blood cancer chronic myeloid leukemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukemia). A biosimilar medicine, Ziextenzo is highly similar to another biological medicine (Neulasta) that is already authorized in the EU.
