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Teva
Teva Reports the Acceptance of Regulatory Submissions for TVB-009P (Biosimilar, Prolia) by the US FDA and EMA 
Shots:  The US FDA and the EMA has accepted Teva’s applications for TVB-009P, biosimilar version of Prolia (denosumab), for all the approved indications, with their decisions anticipated during H2’25  Submissions were built upon the data from P-III (TVB009-IMB-30085) study assessing safety & efficacy of TVB-009P vs Prolia among women with postmenopausal osteoporosis as well as…
October 8, 2024
Teva and mAbxience Join Forces on Second Biosimilar Candidate in Oncology 
  Shots:  Teva and mAbxience have entered into a second global licensing agreement to develop an anti PD-1 biosimilar candidate in oncology  As per the agreement, mAbxience will employ its state-of-the-art, cGMP-compliant facilities in Spain and Argentina for the development & production of biosimilar while Teva will handle its regulatory approvals & commercialization  The agreement…
October 3, 2024
Formycon and Fresenius Kabi
Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases   
Shots:  The EC has approved Otulfi (IV/SC), a biosimilar of Stelara (ustekinumab), to treat mod. to sev. active CD, mod. to sev. plaque PsO & active PsA, valid across EU as well as Iceland, Liechtenstein & Norway  Approval was based on analytical, pre-clinical, clinical & manufacturing data, depicting similar effectiveness, safety & PK profile of…
September 27, 2024
Alvotech Reports the Initiation of Confirmatory Trial of AVT16 (Biosimilar, Entyvio) 
  Shots:  Alvotech has begun the confirmatory trial of AVT16, biosimilar version of Entyvio (vedolizumab), that targets alpha-4-beta-7 protein for treating Ulcerative Colitis and Crohn’s disease  The P-III (AVT16-GL-C01) trial is a double-blind, two-arm study comparing the efficacy, safety & immunogenicity of AVT16 vs Entyvio in patients of age 18-80yrs. with moderate to severe active…
September 25, 2024
IntraBio
IntraBio’s Aqneursa Receives the US FDA’s Approval for Treating Niemann-Pick Disease Type C 
Shots:     The US FDA has granted approval to Aqneursa (levacetylleucine) for treating adults & pediatric patients (≥15kg) with neurological manifestations of Niemann-Pick disease type C (NPC)  Approval was supported by pivotal P-III (IB1001-301) study assessing the effect of Aqneursa vs PBO on neurological symptoms & functioning in pediatric (≥4yrs.) & adults (n=60) with confirmed NPC …
September 25, 2024
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