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United States - Life Sciences, Biotechnology & Nanotechnology - FDA Approves High-Concentration Formulation Of Boehringer Ingelheim s Humira® Biosimilar Cyltezo® (Adalimumab-adbm)

According to a May 1, 2024 press release, the high-concentration (100 mg/mL), citrate-free formulation of Boehringer Ingelheim's Cyltezo® (adalimumab-adbm) was approved by the FDA on May 1.

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Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation | Venable LLP

Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation | Venable LLP
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PTAB Proposes Rules Governing Director Review of PTAB Decisions | Venable LLP

On April 16, 2024, the PTAB proposed new rules (“proposed rules”) governing the Director Review process, which would remain consistent with the Interim review process currently in.

United statesApril breyer menonAdvisory committeeDirector reviewAmerica invents actFinal written decisionFederal circuit

EYLEA® Proposed Biosimilar M710 BPCIA Appeals Dismissed For Lack Of Jurisdiction - Patent

On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron and Mylan / Biocon.

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EYLEA® Proposed Biosimilar M710 BPCIA Appeals Dismissed for Lack of Jurisdiction | Venable LLP

On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron.

April breyer menonFormycon klinge biopharmaMylan bioconDistrict courtFederal circuitKlinge biopharmaSamsung bioepis

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