Over the last few months there have been a number of complete response letters issued by the US Food and Drug Administration (FDA) sent to drugmakers citing manufacturing deficiencies. Sanofi and Regeneron’s rheumatoid arthritis drug sarilumab was recently hit due to problems at a fill/finish plant in France, for example.
But according to Pfenex’s CEO Bert Liang, such regulatory activity is not unusual as – during a call to discuss his firm’s Q3 results – the FDA has been clear on its demands for high quality manufacturing.
While he said there has been a crackdown “particularly with overseas manufacturers,” he added the FDA has been even stauncher on the quality of biosimilar manufacturing.
“It is becoming much more apparent around the quality manufacturing and manifestations that are required in order to move these programs forward, [and] certainly within the biosimilar area this is key,” he told stakeholders.
“We are looking for molecular similarity. That molecular similarity has to be derived from high quality manufacturing and that high quality manufacturing has to be consistent. Within that context that’s the reason why you’re starting to see it a little bit more within the area of biosimilars.”
Liang’s comments on the Agency’s increasing vigilance echoes CDMO Catalent which last week told its stakeholders the FDA continued to up its game, leading to higher regulatory costs for the drugmaker.
Pfenex has six fully-owned biosimilar products in its pipeline, including a version of Roche’s eye mAb Lucentis (ranibizumab) which was being co-developed with Pfizer until the Big Biopharma terminated the project in August.
According to Liang, discussions are at their early stages with potential new partners to further the molecule’s progress.
“Obviously it takes a fair amount of time to be able to move those kinds of discussions forward. That being the case again we’re excited that there’s interest there and we’re going to continue to try to, make these types of relationships work if that’s the best thing for the organisation.”