Complete Response Letters

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.

The Pierre Fabre-partnered allogeneic T-cell immunotherapy is already available in Europe but hopes of a US approval have been hit by a complete response letter citing problems at a third-party manufacturing facility.

During a virtual appearance at a CERSI meeting two days after announcing retirement plans, the CDER director also said she wished agency reviews of unapproved drugs could be published.

Tanvex has seen its application for a trastuzumab biosimilar knocked back by the US Food and Drug Administration, receiving a complete response letter over the filing.

After sharing multiple updates to the regulatory status of its ketamine formulation, PharmaTher received a complete response letter from the FDA, which required minor information and clarifications from the company.