Biocon Receives EIR, Says It Plans to Launch Biosimilar Trastuzumab, Ogivri, in the US "Soon"

The FDA has issued an establishment inspection report (EIR) for Biocon’s Bengaluru facility, where the drug maker manufactures biosimilars, and the FDA’s inspection of the facility, which took place during August 2019, is now closed.

The Bengaluru site also received an EU certification of good manufacturing practice in June of this year, and the FDA in October approved the company’s drug product filling line for 150-mg vials of trastuzumab after a September inspection.

In a statement announcing the EIR, Christiane Hamacher, PhD, the chief executive officer of Biocon Biologics, said, “The EIR for this facility reaffirms our manufacturing capabilities for high quality biosimilars to serve the needs of patients in the [United States].”

Hamacher added that the company’s biosimilar pegfilgrastim, Fulphila, for which it partners with Mylan, is already available in the United States, and that Biocon plans to make its biosimilar trastuzumab, Ogivri, commercially available “soon, leading to tremendous cost savings to the US healthcare system.” Once launched, Ogivri will join Amgen’s recently launched trastuzumab biosimilar, Kanjinti, in competing with the reference product, Herceptin, for the HER2-positive cancer market.

Biocon indicated that it hopes to serve 2.5 million patients in 2020, and 5 million patients—for revenues of $1 billion—by 2022. The company’s trastuzumab biosimilar will play a role in achieving those goals, as will an eventual insulin glargine biosimilar, although the company has not yet been successful in gaining FDA approval of its insulin glargine follow-on product despite 2 filings with the FDA.

Further growth will come, says Biocon, from launches of insulin aspart and bevacizumab biosimilars in global markets.

Biocon’s partner, Mylan, reported this week that its net sales in the North America segment of its business totaled $1.01 billion last quarter, or 14% lower than the same quarter last year. The decrease was largely due to lower volumes of sales for its existing products, like the EpiPen, and Mylan credited sales of Fulphila as having partially offset those lower sales numbers.