As we previously reported, on June 4, 2018, the U.S. FDA approved Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb) as the first biosimilar of Neulasta® to obtain approval in the United States.  Mylan stated at the time that it “anticipate[d] launching Fulphila in the coming weeks[.]”  The next week, Mylan CEO Heather Bresch told CBS News, “We’ll be launching our biosimilar to Neulasta in the coming weeks at a significant reduction.  Double-digits reduction.”  It was subsequently reported that Mylan was pricing Fulphila™ at a wholesale acquisition cost (WAC) of $4175 per syringe, constituting a 33% discount compared to the reference product WAC.

The launch status of Fulphila™, however, has remained unclear.  For example, earlier this week in the related BPCIA patent litigation between Amgen and Mylan concerning this biosimilar product, the parties jointly filed a request for a status conference with the district judge about whether to bifurcate damages and remedies from the liability portion of the case, in which Amgen indicated that it believed that Mylan had launched Fulphila® but was unable to confirm that belief:

To the best of Amgen’s knowledge, Mylan has now launched Fulphila™ commercially and is actively marketing the product. For example, FDA’s National Drug Code Directory website confirms that Mylan started to market Fulphila™ on July 9, 2018. Mylan has also announced its wholesale price for Fulphila™ of $4175 per syringe, more than 30% below the price of Amgen’s Neulasta®. As of July 10, 2018, the last meet and confer between counsel, Mylan’s counsel was not able to confirm to Amgen whether or not Mylan has launched Fulphila™.

Biocon now appears to have cleared up the uncertainty. In a press release today announcing Biocon’s quarterly financial results, Biocon stated that Mylan has launched Fulphila™:

Biocon’s partner Mylan has launched the first U.S. FDA-approved biosimilar Pegfilgrastim, Fulphila™, as a more affordable therapy option for cancer patients undergoing chemotherapy in the U.S.

Fulphila™ is the first biosimilar Pegfilgrastim (pegfilgrastim-jmdb) to be approved by the U.S. FDA in June 2018.  Biocon is the first company from India to have its biosimilar commercialized in the U.S.

The regulatory reviews of our biosimilar Pegfilgrastim dossier in EU, Australia and Canada are progressing well.

Stay tuned to Big Molecule Watch for further developments.