Tags : Proposed Biosimilar

Biosimilars Regulatory

Alvotech’s AVT02 (a proposed biosimilar to Humira) Receives CHMP’s Positive

Shots: The EMA’s CHMP has recommended the approval of Alvotech‘s AVT02 (100 mg/mL), a proposed biosimilar to Humira (adalimumab)  to treat AD in the EU The EC has been assigned to discuss the marketing authorization for AVT02. If approved, AVT02 will be extended to all EU member states along with other countries in the EEA, Iceland, Liechtenstein, […]Read More

Biosimilars Clinical Trials

Gan Lee Presents P-I Results of Proposed Biosimilar Insulins Aspart,

Shots: The company reported that all the P-I studies assessing insulin aspart (GL-ASP), insulin lispro (GL-LIS), and insulin glargine (GL-GLA) met their primary PK & PD analyses and demonstrated that PK/PD bioequivalence b/w each of the proposed biosimilar and their respective reference compounds The safety profiles were comparable b/w each of the three proposed biosimilar […]Read More

Biosimilars

Samsung Bioepis Initiates P-Ill Study of SB16 Proposed Biosimilar to

Shots: The P-lll study will assess the efficacy, safety, pharmacokinetics PK/PD, and immunogenicity of SB16 vs Prolia in 432 female volunteers for postmenopausal osteoporosis The company has initiated the P-I study to compare the PK/PD, safety, tolerability, and immunogenicity b/w SB16 and Prolia in healthy volunteers in Oct’2020 Samsung Bioepis has three biosimilar candidates – […]Read More

Biosimilars

Samsung Bioepis Reports the Initiation of P-III Study for SB15

Shots: The P-III study will compare the efficacy, safety, PK, and immunogenicity between SB15 and Eylea in 446 patients with neovascular age-related macular degeneration The company has two ophthalmology biosimilar candidates in clinical development, SB11 (ranibizumab) and SB15 (aflibercept). On May 18, 2020, Samsung Bioepis reports 24-week interim results from a P-III study of SB11 […]Read More