Still Space for Multiple Neulasta Biosimilars, says Pfenex

Pfenex has deprioritized its pegfilgrastim biosimilar program but is reevaluating the market after Mylan’s recent success in the US.

In June, the US Food and Drug Administration approved Mylan’s Fulphilia on its second attempt. While Fulphilia has become the first biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim), there are several other firms looking to tap the market, including Coherus and Novartis subsidiary Sandoz.

Clinical-stage development and licensing biotech Pfenex too has a pegfilgrastim biosimilar in its pipeline, PF529, but announced in its third quarter 2017 financial call it has placed development on hold in favor of focusing its efforts and resources elsewhere in its product portfolio.

Speaking as part of the Insider Daily series at BIO in June, chief business officer Patrick Lucy said Pfenex continues to look for partnering opportunities and is keeping a close eye on market developments.

“We’ve deprioritized [PF529] previously because of others ahead of us,” he said, mentioning Mylan’s recent success. “But with a US$5 billion market, we think there’s still space there for multiple products, and that’s still being evaluated based upon others in the pipeline and whether or not other companies get approval for that product.”

Biosimilars and ‘Biobetters’

Pfenex’s lead candidate is PF708 is a version of Eli Lilly’s osteoporosis drug Forteo (teriparatide), being developed as a biosimilar in Europe but as a therapeutic equivalent in the US via the 505(b)(2) pathway. If approved, it will be commercialized by Alvogen in the US.

The firm also has a biosimilar of Roche/Novartis’ Lucentis (ranibizumab) it was co-developing with Hospira. Pfizer, which acquired Hospira in 2015, handed back the rights and Pfenex has put development on hold.

“That product has been in a Phase I/II study,” said Lucy. “Right now we’re actively seeking a partner to advance that into a Phase III study and a filing.”

Pfenex’s products are made using the Pfenex Expression Technology platform, based on the bacterium Pseudomonas fluorescens. The expression tech has several advantages over other microbial and mammalian platforms, something that could lead Pfenex to move beyond biosimilars going forward, said Lucy.

“Can we look at biobetters? Is there a way to leverage the technology to further improve existing products?” he asked. “It may not be the biosimilar pathway but going the [351(a) pathway, the pathway for approval of innovator biologics] may be a faster path through to a clinical trial.”