2020 Year in Review - Biosimilars
2020 Year in Review - Biosimilars | January 25, 2021
The totality of evidence generated from comparative systematic stepwise assessment of HD201 and trastuzumab reference in terms of analytical, pharmacodynamic, pharmacokinetic, and clinical similarity demonstrated the equivalence of HD201 to trastuzumab.
2020 Year in Review - Biosimilars | January 25, 2021
Population-based study results support the use of the neoadjuvant chemotherapy + pertuzumab + trastuzumab biosimilar SB3 treatment regimen in the real-world setting, with responses comparable with those achieved in clinical trials.
2020 Year in Review - Biosimilars | January 13, 2021
An ongoing extension study from the phase 3 trial of trastuzumab biosimilar SB3 and trastuzumab reference supports similarity in terms of long-term cardiac safety and survival in patients with HER2-positive, early or locally advanced breast cancer.
2020 Year in Review - Biosimilars | January 13, 2021
Real-world data indicate the efficacy and safety profile of the biosimilar trastuzumab-dttb + pertuzumab was consistent with that previously reported for trastuzumab reference + pertuzumab in patients with HER2-positive breast cancer.
2020 Year in Review - Biosimilars | January 13, 2021
Interim results from the phase 3 TROIKA trial demonstrate clinical equivalence between the biosimilar HD201 and trastuzumab reference in terms of efficacy, safety, pharmacokinetics, and immunogenicity in patients with HER2-positive early breast cancer.
2020 Year in Review - Biosimilars | January 13, 2021
Exploratory analyses of a phase 3 trial comparing infliximab-qbtx to reference infliximab in patients with rheumatoid arthritis (RA) indicate that multibiomarker disease activity score may be used as an assessment of biosimilarity instead of conventional disease activity measures.
2020 Year in Review - Biosimilars | January 13, 2021
Preliminary real-world retrospective data indicate comparable safety profiles for infliximab-dyyb and infliximab in pediatric rheumatic conditions.
2020 Year in Review - Biosimilars | January 13, 2021
The findings of a retrospective study indicate that successive switching from reference to 2 different biosimilars was not associated with clinically significant changes in disease activity and function in patients with inflammatory rheumatic diseases.
2020 Year in Review - Biosimilars | January 13, 2021
Real-world data from the prospective, observational COMPANION-B study showed that the biosimilar SB4 had similar efficacy over 12 months compared with etanercept reference in patients with well-controlled rheumatoid arthritis with stable disease.
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