Alvotech Tries Again for FDA Interchangeable Designation for Humira Biosimilar

FDA Entrance_iStock, Grandbrothers

Pictured: Exterior view of the FDA's headquarters in Maryland/iStock, Grandbrothers

Alvotech has resubmitted its Biologics License Application to the FDA seeking an interchangeability designation for AVT02, its high-concentration biosimilar formulation of AbbVie’s Humira (adalimumab), CEO Robert Wessman announced in an investor call Thursday.

Wessman did not disclose a target action date yet but said that Alvotech is working toward a “satisfactory inspection” of its manufacturing campus in Reykjavik, Iceland. If approved, the biotech company also expects AVT02 to be a “material contributor” to its business in 2024.

The FDA has already rejected AVT02 twice. The first was in April 2023, with the regulator citing deficiencies at the Iceland facility in its Complete Response Letter. The second rejection came in June, when the FDA turned down Alvotech’s bid for an interchangeability designation for AVT02.

In July, Alvotech broadened its collaboration with development partner Teva Pharmaceuticals, which involved the latter’s “increased involvement” in manufacturing and quality control at the Reykjavik plant.

Alvotech’s plant was slapped with a warning letter from the FDA in March 2022, which revealed several quality control issues. These included “an unacceptably high number of mold recoveries” from drug manufacturing rooms. The FDA also documented bacterial contamination exceeding acceptable levels.

In addition, the company’s corrective and preventive measures were deemed “inadequate” by the regulator as they did not ensure that future contaminations could be avoided.

These issues were no longer detected in a follow-up inspection a year later.

“We have made and continue to make significant investments in our manufacturing and quality processes and have taken the feedback received from FDA inspections to focus these investments,” Wessman said during Thursday’s call. “We are confident that the changes that we have made at our site to put the company in the best positions for our satisfactory reinspection.”

If approved, AVT02 will face off with at least eight Humira biosimilars, a group led by Amgen’s Amjevita, which hit the U.S. market in January 2023. The floodgates opened in July, with several other biosimilars launching including Celltrion’s Yuflyma, Organon’s and Samsung Bioepis’ Hadlima, Sandoz’s Hyrimoz and Boehringer Ingelheim’s Cyltezo.

Of these, only Cyltezo has the interchangeability designation, which allows pharmacies to dispense it in place of its branded counterpart without needing a change in prescription.

Alvotech on Thursday also reported its financial results for the first half of 2023 posting $22.7 million in earnings, a substantial increase from its $3.9 million revenue over the same period last year.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Correction (September 1): This story has been updated to include a mention of the follow-up inspection at Alvotech’s Iceland facility, where the quality control issues were no longer flagged.

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