It took a 3-year struggle, but Novartis finally gets a green light on their copycat to Amgen's big blockbuster
Over three years after the first rejection and less than three months after the last one, Novartis has finally earned FDA approval for its biosimilar to Amgen’s $4 billion cancer drug Neulasta. And they’re calling it Ziextenzo.
Unlike the 2016 and 2019 rejections — both of which the Swiss giant tucked in as a line item on a quarterly report — Novartis announced the approval in a statement Tuesday morning.
“The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option,” Carol Lynch, president of Novartis’s Sandoz generics division, said in a statement.
The approval is a significant victory in Novartis’ long-running battle to churn out copycats to some of its rivals’ biggest drugs. In 2016, the company unveiled an ambitious plan to launch 11 biosimilars by 2020. They singled out as top targets Amgen and Pfizer’s Enbrel, AbbVie’s Humira, Amgen’s Neulasta, J&J and Merck’s Remicade, and Roche’s Rituxan.
Three years later and with 2020 two months away, the Neulasta biosimilar is the second of those 5 targets that appears set to hit the US market. (Three have been FDA approved but Erelzi, their rival to Enbrel, has been held up in a legal battle with Amgen). And they were beaten to Neulasta by comparatively far smaller firms. Last year, Coherus and Mylan each put out an FDA-approved copycat to Amgen’s blockbuster.
The holdup on this and other drugs, though, has at times had less to do with development than with the shifting legal and regulatory landscape, especially in the US. Novartis has eight biosimilars approved in Europe, but only four in the US.
There’s no word yet on pricing from Novartis but Mylan and Coherus each launched their biosimilars at a 33% discount on Amgen’s Neulasta. The drugs are used to stave off infection by boosting white blood cell counts decimated by chemotherapy.