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On December 18, 2020, the FDA approved the oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix (Orgovyx; Myovant Sciences), for the treatment of adult patients with advanced prostate cancer. As an GnRH receptor, relugolix reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer. Read More ›

On December 1, 2020, the FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11; University of California), the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. Ga 68 PSMA-11 is indicated for men with suspected metastatic prostate cancer that may be curable by surgery or by radiation, and for suspected recurrent prostate cancer based on elevated serum prostate-specific antigen (PSA) levels. Read More ›

Real-world utilization data indicate that treatment outcomes with infliximab biosimilars were similar to those with reference infliximab in patients with rheumatoid arthritis. Read More ›

The findings of an online, cross-sectional survey indicate oncologists were less likely to prescribe biosimilars if their practice could lose money and control of the drug, despite clinical safety and efficacy between the biosimilar and originator. Read More ›

Exploratory analyses of a phase 3 trial comparing adalimumab-afzb with reference adalimumab in patients with rheumatoid arthritis (RA) indicate a multibiomarker disease activity score may be a sensitive and objective assessment of biosimilarity that does not require subjective assessments needed for conventional disease activity measures. Read More ›

Data from the ongoing PROPER study indicate switching from reference adalimumab to its biosimilar SB5 was not associated with any clinically meaningful difference in disease score from baseline in patients with rheumatoid arthritis (RA), axial spondyloarthritis, or psoriatic arthritis. Read More ›

Final analysis data from a confirmatory, randomized phase 3 study demonstrated clinical similarity between rituximab reference and its biosimilar ABP 798 in patients with CD20-positive non-Hodgkin lymphoma in terms of efficacy, safety, and immunogenicity. Read More ›

Longer-term follow-up supports earlier evidence that treatment switch from adalimumab-EU to PF-06410293 does not impact treatment safety, immunogenicity, and efficacy in patients with moderate-to-severe, active rheumatoid arthritis. Read More ›

Interim analysis results from the prospective, postapproval REFLECT study indicate the Sandoz rituximab biosimilar treatment was associated with safety and efficacy profiles consistent with those previously described for R-CHOP in untreated patients with diffuse large B-cell lymphoma. Read More ›

A randomized, double-blind phase 3 study demonstrated the efficacy and safety equivalence of the adalimumab biosimilar candidate CT-P17 to reference adalimumab in patients with moderate-to-severe active rheumatoid arthritis (RA). Read More ›