This is the second biosimilar to pass through regulatory scrutiny. The FDA previously approved the Novartis Zarxio, a copy of Amgen’s Neupogen, last year.
The FDA’s ruling on biosimilars suggests that the government is growing more open to moving biosimilars through the regulatory process, which could help support the generic drug industry’s next growth spurt. The FDA could use looser criteria for marketing approval than some observers anticipated.
However, drugmakers like J&J, AbbVie (NYSE: ABBV) and Amgen (NasdaqGS: AMGN) are trying to block the biosimilars and are making new U.S. patents to extend their monopolies into the 2020s and 2030s.
Max Chen contributed to this article.