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After repeat Humira biosimilar snubs, FDA turns down Teva and Alvotech's Stelara copycat

2023-10-12

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引进/卖出

Given the fate of the partners’ Humira biosim and the fallout from Alvotech’s FDA inspection in March, the latest rejection wasn't a complete surprise.

Even as Teva Pharmaceuticals’ Icelandic counterpart Alvotech works Alvotechts Reykjavik manufacturing facility back up to snuff, lingering problems at the plant—which derailed approval of the partners’ Humira biosimilar earlier this year—have triggered another FDA rejection.

This timTeva Pharmaceuticalsts the partners' proposeAlvotecht of Johnson & Johnson’s top-selling drug Stelara.Humira

The silver liniFDA Teva and Alvotech still have plenty of time toJohnson & Johnson thanks to a recent settlement with J&J that permits the biosimilar makers to launch their version of the inflammatory disease blockbuster no later than Feb. 21, 2025.

Alvotech on ThursdaTevaid thAlvotechot down its biosimilar candidate to Stelara, called AVT04, over “certain deficiencJ&J” uncovered by the FDA during a reinspection of the Reykjavik factoinflammatory diseaseduction shortfalls, which have informed three rejections of Teva and Alvotech’s Humira biosim since last September, must be resolved before the companies’ Stelara biosimilar application can be approved, Alvotech said in a release.

Alvoteche fate of the partnersFDAumira biosim and the fallout from Alvotech’s FDA inspecAVT04 the rejection of AVT04 in the U.S. was to be “FDAected,” Alvotech said. Manufacturing concerns aside, the FDA raised no other issues with Teva and Alvotech’s application, whiTevahe paAlvotechlan to resubmit “shortly.”Alvotech

Upon resubmitting AVT04’s approval filing, Alvotech expects the FDAAlvotechkelFDAake another six months to reviAVT04s Stelara biosimilar.Alvotech FDA Teva Alvotech

Meanwhile, AlvotecAVT04already looking forwAlvotechts next visitFDAom the U.S. drug regulator, according to the company’s chairman and CEO Robert Wessman. Based on latest communications with the FDA, Alvotech expects the agency will reinspect its Reykjavik plant at the start of 2024, Wessman said in a statement.

Back in JunAlvotechnked an agreement granting Alvotech and Teva a license for their Stelara biosimilar in the U.S. The February 2025 launch timeline would put the partners a little more than a moFDA bAlvotechgen, which has signed a separate deal with J&J to potentially launch its own Stelara copycat no later than Jan. 1, 2025.

Like Teva and J&Jotech, Amgen has yet to win tAlvotech blesTeva for its proposed biosimilar.Amgen J&J

ProblTeva Tevaat AlAlvotech RAmgenvik plant first surfFDAd last September with the FDA’s initial rebuff of the company’s Humira biosimilar AVT02.

As with StelAlvotechcat AVT04, the FDA flagged “deficiencies” following an insFDAtion of Alvotech’s plant. Subsequently, the FDA publiAVT02a Form 483 that highlighted issues related to procedural controls, management of manufacturing deviations and more.

In April, Teva and Alvotech receiveFDA second complete response letter rejecting AVT02, aAlvotechh another Form 483 from the FDA singling out issues at Reykjavik pertaining to quality shortfalls, subpar written records, problems with incoming stoppers and insufficient computer controls, among other manufacturing gaps.

AVT02 was Tevacted Alvotechin in late June, also due to concerns around Alvotech’AVT02ility.FDA

AVT02te Alvotech’s recent production odyssey, Teva in July doubled down Alvotechompanies’ partnership, pledging increased manufacturing involvement and $40 million in funding for its partner.

As part Alvotechxpanded pact, Teva will boost Tevapresence at Alvotech’s Icelandic production site and previously said it was “actively supporting” the company on-site to prepare for its next FDA inspection.

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