Tags : (adalimumab)

Alvotech Signs an Exclusive License Agreement with DKSH for AVT02

Shots: Alvotech will be responsible for the development and supply of AVT02 in selected APAC market, while DKSH will be responsible for the registration and commercialization of the therapy The alliance allows the Alvotech to gain access to DKHS’s commercial expertise, which will aid patients to get benefited with high-quality biosimilar therapies AVT02 is a […]Read More

Celltrion Reports Submission of MAA to EMA for CT-P17 (biosimilar,

Shots: Celltrion has applied for the commercial approval of CT-P17, a biosimilar referencing Humira (adalimumab) in the EU The submission is based on clinical data targeting all approved indications of Humira, including RA, UC, and psoriasis and is expected to be available in the EU market in about a year. Additionally, Celltrion is conducting P-III […]Read More

Boehringer Ingelheim Report Results of BI 695501 in P-III Trial

Shots: The P-III study involves assessing BI 695501 vs Abbvie’s Humira in 147 patients with mod. to sev. CD that were either TNF naïve or prior treated with infliximab The P-III study results demonstrated non-inferior efficacy and similar safety profile to the reference product, met its 1Eps i.e, CDAI response @4wks. (89.7% vs 94.4%); infection […]Read More

Pfizer’s Amsparity (biosimilar, adalimumab) Receives CHMP’s Positive Opinion for Inflammatory

Shots: The EMA’s CHMP has recommended marketing authorization of Amsparity, a biosimilar referencing AbbVie’s Humira Amsparity will be available in a 40 mg pre-filled syringe and pre-filled pen for adults and a 20 mg pre-filled syringe and 40 mg/0.8 mL vial for children. Amsparity showed high bio-similarity data in terms of quality, safety and efficacy […]Read More

Bio Thera’s QLETLI (biosimilar, adalimumab) Receives NMPA’s Approval for Auto-Immune

Shots: The approval of QLETLI is based on P-III study resulted in meeting its 1EPs, demonstrating bio-similarity to the reference product, Humira (adalimumab) including clinical/nonclinical, PK/PD data The approval of QLETLI marks the first approval in a regulated market from Bio Thera’s biosimilar portfolio and is the second biosimilar to be approved by NMPA QLETLI […]Read More

Samsung Bioepis’ Hadlima (biosimilar, adalimumab) Receives FDA’s Approval for Autoimmune

Shots: The FDA’s approval is based on P-III clinical study assessing Hadlima vs reference product, Humira (adalimumab) in 544 patients in a ratio (1:1) with moderate to severe rheumatoid arthritis despite methotrexate therapy The P-III clinical study resulted in biosimilarity data of Hadlima to the reference product Humira, i.e, @24 wks. ACR20 (72.4% vs 72.2%). […]Read More