Sep 6, 2022 · In a statement Monday, Alvotech said the FDA had informed it that deficiencies in the company’s manufacturing plant in Reykjavik need to be corrected before it can launch the drug in the U.S. The regulator’s complete response letter follows a factory inspection that took place in March.
The pharmaceutical manufacturer must ensure that the chosen container closure system (e.g., glass vial + elastomeric stopper + aluminum crimp seal) provides this protection for the specific drug product in a suitable manner throughout its shelf life.
Single Dose Vial, Lot #0048 Due to Translucent Visible Particles-Glass delamination • 1-1-2011 Acetadone (acetylcysteine) Injection: Recall – Particulate Matter Found in a Small Number of Vials-Glass particles • 12-23-2010 American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection, USP
Sep 21, 2021 · Alvotech said that the FDA needs to complete manufacturing facility inspections to ensure compliance with US standards for drug production and cannot do so because of travel restrictions imposed because of the pandemic. “Alvotech continues to work with the FDA to coordinate the required inspections in a safe and adequate manner,” the company said.
Feb 1, 2016 · The manufacturing of glass vials includes several steps. After the vial shaping process, surface imperfections are removed by a fire polishing process. Finally, the vials are annealed in a lehr oven to reduce stresses within the glass. 2.2. Rubber stoppers The elastomeric rubber stopper is a complex part of the primary packaging [6].
Dec 22, 2022 · FDA sets decision date for Alvotech’s Humira biosimilar The regulator still needs to inspect a manufacturing site before deciding on approval of Alvotech’s copycat version of the best-selling inflammatory disease drug. Published Dec. 22, 2022 Jonathan Gardner Senior Reporter Sarah Silbiger via Getty Images
Jun 15, 2022 · REYKJAVIK, ICELAND & NEW YORK, June 15, 2022 -- ( BUSINESS WIRE )--Alvotech, a global biotech company focused solely on the development and manufacture of biosimilar medicines for patients
Feb 28, 2022 · Reykjavik, Iceland (February 28, 2022) — Alvotech Holdings S.A. (“Alvotech”), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics Licensing Application
Aug 5, 2020 · Alvotech‘s initial pipeline contains several monoclonal-antibody and fusion-protein biosimilar candidates aimed at treating autoimmunity, oncology, ophthalmology and inflammatory conditions to improve quality of life for patients around the world.
Mar 8, 2022 · Reykjavik, Iceland (March 8, 2022) — Alvotech Holdings S.A. (“Alvotech”), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, announced today that is has executed a U.S. settlement agreement with AbbVie (NYSE: ABBV) that grants Alvotech non-exclusive rights to market
In a write-up of Alvotehc's Reykjavik, Iceland, manufacturing facility, the FDA laid out 13 observations, including chidings related to procedural controls, management of manufacturing deviations
Sep 7, 2022 · Alvotech filed AVT02 – a version of AbbVie’s bestselling monoclonal antibody (mAb) Humira (adalimumab) – last year but this week announced the US Food and Drug Administration (FDA) has rejected the initial biosimilar Biologics License Application (BLA), due to issues at its manufacturing plant.
Sep 13, 2022 · The FDA found that Alvotech’s facility, inspected in March, lacked the procedural controls to ensure that incoming materials were properly qualified, as an internal
Administration (FDA) noting certain deficiencies related to the March 2022 inspection of Alvotech s manufacturing facility in Reykjavik, Iceland, and stated that satisfactory resolution of the deficiencies is required before FDA may approve this BLA. Alvotech progressed discussions with the FDA in addressing outstanding issues.
The filling of vials that are to be lyophilized has some problems that are somewhat unique. The stopper is placed on top of the vial and is ultimately seated in the lyophilizer.
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