Tags : ABP 798

Regulatory

Amgen and Allergan Report Submission of BLA to the US

Shots: The BLA submission is based on two studies assessing ABP 798 vs Rituxan which resulted in analytical, PK and clinical data showing no clinically meaningful differences between products In Dec, 2011 Amgen and Allergan globally collaborated to develop and commercialize four oncology antibody biosimilar medicines ABP 798 is a mAb CD20-directed cytolytic mAb approved […]Read More

Insights+

Insights+ Key Biosimilars Events of August 2019

Biosimilars are key alternatives for costly Biologics therapies and saving million dollars of patients in multiple diseases. Hence physicians are likely to adopt biosimilars “a reference product to biologics” possessing similar therapeutic properties in terms of potency, safety, and efficacy to original biologic products. Our team at PharmaShots has summarized key events of biosimilar space […]Read More

Biosimilars Biotech

Amgen and Allergan Report Results of ABP 798 (rituximab, biosimilar)

Shots: The P-I/III (NCT02792699) study involves assessing of ABP 798 vs Rituxan (rituximab, IV) in 311 patients in the ratio (1:1:1) with moderate-to-severe RA, evaluating safety, efficacy, and PK for 48 wks. The study demonstrated in meeting 1EPs as AUC (area under the serum concentration–time curve) and Cmax (maximum serum concentration) with biosimiliarity in PK, efficacy, and safety ABP 798 (rituximab, biosimilar) is […]Read More