Approval of sBLA for Mylan and Biocon's Biosimilar Pegfilgrastim Will Allow for Scale-up, Companies Say

Biocon announced today that its supplemental Biologics License Application (sBLA) for its biosimilar pegfilgrastim, Fulphila, filed with partner Mylan, has been approved by the FDA.

The additional approval relates to Biocon’s new manufacturing facility for the biosimilar in Bengaluru, India. The FDA conducted its preapproval inspection of the new drug substance manufacturing facility from September 10 to September 19 of this year.

The new facility will allow Biocon and Mylan to scale up capacity “multi-fold,” said the company in a statement, to address the growing market for the biosimilar in the United States and around the world. Fulphila, the first biosimilar pegfilgrastim to launch in the United States commercially, currently competes with Coherus Biosciences’ Udencya and Sandoz’s Ziextenzo for a share of the brand-name Neulasta’s market.

Biocon’s chief executive officer, Christiane Hamacher, PhD, said in a statement announcing the sBLA’s approval that “This is a significant milepost in our journey,” and that the company expects to serve 5 million patients—and cross a revenue threshold of $1 billion—by financial year 2022. She also pointed to the benefits for the US healthcare system, saying that biosimilar penetration will enable better cost saving and greater patient access to high-quality treatment.

News of the progress for Fulphila comes shortly after Biocon announced that the FDA had issued an establishment inspection report for its Bengaluru facility and that the company would now be in a position to launch its long-awaited trastuzumab biosimilar, Ogivri, which is also approved by the FDA, “soon.”

Biocon, which also makes biosimilar insulins, has also recently announced its plans to improve access to high-quality insulins for patients with diabetes worldwide. As part of its universal access initiative, the company has said that it will offer human recombinant insulin at a cost of less than 10 cents per day for government procurement agencies in low- and middle-income countries.

Biocon will further discuss its access program during next week’s International Diabetes Federation Congress in Busan, South Korea.