Complete Response Letters

As Dr Reddy’s delivered results for its financial third quarter, the firm revealed a slew of updates for key biosimilars in its pipeline including filing and launch plans for abatacept in the US and Europe, as well as US setbacks on rituximab and denosumab.

What exactly is causing Alvotech’s frustrating list of US complete response letters? In a recent call with investors, management shed light on the company’s issues.

The Paris-headquartered firm has been hit with a complete response letter for its oral BTK inhibitor, quite a shock given that it was not expecting to hear from the US agency on its application for the multiple sclerosis drug until early next year.

The FDA rejection of Alvotech’s AVT06 Eylea biosimilar was revealed as part of a wider funding update outlining a $108m bond placement and continued heavy R&D investment.

The US FDA had good news and bad news for Alvotech as it issued a complete response letter for its Teva-partnered golimumab biosimilar. While manufacturing deficiencies must be resolved before the Simponi rival can be approved, the FDA “did not identify any other deficiencies with the application.”

Xbrane Biopharma has suffered yet more frustration in its attempt to win US approval for its proposed Lucamzi biosimilar to Lucentis, receiving another knockback from the FDA that has forced it to reorganize its finances.

Xspray Pharma has received a second FDA complete response letter for its 505(b)(2) dasatinib tablet, Dasynoc, after manufacturing observations at a contract facility delayed approval despite no issues with the drug’s data package.

Another regulatory blow has not stopped Outlook Therapeutics and its ophthalmic bevacizumab, yet.

FDA's release of CRLs for unapproved products could bring a court challenge, but for now, sponsors should expect all past and future letters will be made public, experts said.

Generics Bulletin reviews global regulatory developments across the world.

After pinning its hopes on a trial that did not meet its primary endpoint, Outlook Therapeutics is disappointed that the US FDA has again rejected its Lytenava ophthalmic formulation of bevacizumab, with the firm pointing to “only one deficiency, for a lack of substantial evidence of effectiveness.”

PTC said it got a complete response letter for the Friedreich’s ataxia drug, with the agency asking for an additional clinical trial.