Ali Ahmed, senior vice president of biosimilars for Fresenius Kabi USA discusses FDA review of the company’s Stimufend pegfilgrastim biosimilar candidate and the marketing of this product.
In this interview, The Center for Biosimilars® speaks with Ali Ahmed, senior vice president of Biosimilars for Fresenius Kabi USA. Ahmed talks about the prospects for the company’s pegfilgrastim biosimilar candidate (Stimufend, referencing Amgen’s Neulasta).
He also discusses Fresenius Kabi’s planned tocilizumab biosimilar candidate (MSB11456), for which positive results were recently reported. MSB11456, for the treatment of rheumatoid arthritis, would reference Actemra.
The company is awaiting completion of an FDA site inspection to enable the completion of the Stimufend application review. Backlogs at the FDA largely owing to COVID-19 have slowed the process for many manufacturers. “We do know that there’s a shortage of resources and they’re doing the best they can under the circumstances,” Ahmed says. The company is cautiously optimistic about an approval in the near future.
For Fresenius Kabi, launching Stimufend would represent the launch of the company’s biosimilars business and an opportunity to extend Fresenius Kabi’s oncology business in the United States. “We have a very robust portfolio with something on the order of 34 different chemotherapy agents currently on the market,” Ahmed says.
The market for pegfilgrastim products is competitive and prices have declined significantly since the first biosimilars appeared. Ahmed says that Fresenius Kabi hopes to compete by differentiating Stimufend via strong customer relationships and patient support, rather than a lowest-cost strategy.
The company has sized up the European Union market for pegfilgrastim biosimilars, and Ahmed notes a chief difference there vs in the United States is that Amgen’s successful Onpro wearable pegfilgrastim device is not available in Europe currently. This product has a roughly 50% share of the market in the United States, and so the competitive dynamics are very different on one side of the Atlantic vs the other. Ultimately, though, Fresenius Kabi does hope to bring a wearable injector to market, Ahmed says.
When it comes to bringing a tocilizumab product to the US market, Fresenius Kabi could be the first, Ahmed notes.