Novartis has announced receipt of U.S. approval for its long-delayed version of Amgen’s Neulasta drug, helping the Swiss drugmaker in its uphill battle to sell copies of its rivals’ blockbusters in the world’s top drug market. Novartis’s biosimilar, called Ziextenzo, was knocked back in 2016 when the U.S. FDA rejected Novartis’s submission. That underscored challenges makers of cheaper copies of blockbuster biological medicines face in the United States, compared to the positive reception they have got in Europe. The FDA’s 2016 rejection allowed Coherus BioSciences and Mylan to beat Novartis to the U.S. market with their own Neulasta copies. Novartis now hopes to launch Ziextenzo this year. Learn More