- |||||||||| Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
Journal: The Totality of Evidence and Use of ABP 215, a Biosimilar to Bevacizumab. (Pubmed Central) - Dec 19, 2020
The ABP 215 solution should be stored at 2-8 °C (36-46°F) prior to use. Physicochemical stability studies showed that there were no meaningful changes in purity or potency and no loss of protein after storage at 2-8 °C for 35 days followed by storage at 30 °C for 48 h.
- |||||||||| Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Trial completion date, Trial initiation date, Trial primary completion date, Metastases: A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - Nov 24, 2020
P3, N=170, Not yet recruiting,
Percent of mCRC patients with prior bevacizumab use (n=972) according to days between final bevacizumab infusion and bevacizumab-awwb initiation. Trial completion date: Jul 2022 --> May 2023 | Initiation date: Jan 2021 --> Jan 2022 | Trial primary completion date: Jul 2022 --> May 2023
- |||||||||| Zirabev (bevacizumab biosimilar) / Pfizer, Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
[VIRTUAL] Biosimilar usage in practices within the ASCO PracticeNET learning network. () - Sep 4, 2020 - Abstract #ASCOQC2020ASCO_QC_148;
Our analysis identified an approximate 2-year lag from product approval to initial utilization followed by a steady increase in the use of biosimilar products, along with a wide range of use among practices. Research Funding: None.
- |||||||||| Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
Review, Journal: Biosimilars as a Future, Promising Solution for Financial Toxicity: A Review with Emphasis on Bevacizumab. (Pubmed Central) - Aug 26, 2020
Over the last decade, the use of generics has saved billions of dollars every year, and it is expected that biosimilars will soon prove to be a cost-effective alternative and can play an important role in driving down healthcare costs globally. In this review, we provide a critical appraisal of biosimilars with an emphasis on bevacizumab-awwb (Avastin) and its clinico-pharmacologic characteristics, safety, efficacy, interchangeability, regulatory and oncologic perspectives, and overall clinical perception.
- |||||||||| Zarzio (filgrastim biosimilar) / Novartis
Journal: The Era of Therapeutic Biosimilars Has Arrived: What You Need to Know. (Pubmed Central) - Aug 12, 2020
At the NCCN 2019 Annual Congress: Hematologic Malignancies, Dr. Andrew D. Zelenetz, Memorial Sloan Kettering Cancer Center, outlined important issues regarding the use of biosimilars, including extrapolation, interchangeability, and naming.
- |||||||||| Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
Journal: Totality of evidence in the development of ABP 215, an approved bevacizumab biosimilar. (Pubmed Central) - May 23, 2020
ABP 215 was shown to be structurally, functionally and clinically (pharmacokinetic, efficacy and safety) similar to the bevacizumab reference product; the pharmacokinetic study was conducted in healthy adult men (n = 202); safety and efficacy were evaluated in patients with advanced nonsquamous non-small-cell lung cancer (n = 642). Together, these results comprise the totality of evidence that provides scientific justification for extrapolation to all approved indications of the reference product and supports the clinical value of ABP 215 as an additional treatment option.
- |||||||||| paclitaxel / Generic mfg., Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
Clinical, P3 data, Journal: Efficacy & Safety of Biosimilar ABP 215 Compared with Bevacizumab in Patients with Advanced Non-small Cell Lung Cancer(MAPLE):A Randomized,Double-blind,Phase 3 Study. (Pubmed Central) - May 13, 2020
ABP 215 is similar to bevacizumab RP with respect to clinical efficacy, safety, immunogenicity, and pharmacokinetics. The totality of evidence supports clinical equivalence of ABP 215 and bevacizumab.
- |||||||||| Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
[VIRTUAL] Demographics and clinical characteristics of metastatic colorectal cancer patients treated with a biosimilar to bevacizumab () - May 13, 2020 - Abstract #ESMOGI2020ESMO_GI_350;
Background Bevacizumab-awwb, a biosimilar to bevacizumab, is the first therapeutic biosimilar to receive FDA approval for the treatment of metastatic colorectal cancer (mCRC) with intravenous 5-FU-based chemotherapy for first-line or second-line treatment, as well as for use in treatment regimens for first-line non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, and metastatic cervical cancer...Legal entity responsible for the study Amgen Inc., Thousand Oaks, CA. Funding This study is funded by Amgen, Inc., Thousand Oaks, CA.
- |||||||||| Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, Allergan
FDA event, Journal: FDA's Approval of the First Biosimilar to Bevacizumab. (Pubmed Central) - Nov 11, 2019
The FDA approved ABP215 (MVASI, bevacizumab-awwb; Amgen) as a biosimilar to U.S.-licensed Avastin (bevacizumab; Genentech) based on an extensive comparative analytic characterization, data obtained in a pharmacokinetic similarity study in healthy subjects, and a comparative clinical study in patients with non-small cell lung cancer...The Food and Drug Administration approved ABP215 (MVASI, bevacizumab-awwb, Amgen) as a biosimilar to US-licensed Avastin (bevacizumab, Genentech) based on an extensive comparative analytical characterization, data obtained in a pharmacokinetic similarity study in healthy subjects, and a comparative clinical study in patients with non-small cell lung cancer. The totality of the evidence for biosimilarity supported extrapolation of the data to support licensure as a biosimilar for other approved indications of US-licensed Avastin, without the need of additional clinical studies.
- |||||||||| Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, Allergan
Journal: Analytical and functional similarity of Amgen biosimilar ABP 215 to bevacizumab. (Pubmed Central) - Aug 15, 2019
The large dataset allows meaningful comparisons and garners confidence in the overall conclusion for the analytical similarity assessment of ABP 215 to both US- and EU-sourced bevacizumab. The structural and purity attributes, and biological properties of ABP 215 are demonstrated to be highly similar to those of bevacizumab.
- |||||||||| Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, Allergan
FDA event, Journal: FDA Approves First Biosimilar to Treat Cancer. (Pubmed Central) - Aug 9, 2019
The FDA approved the VEGF inhibitor bevacizumab-awwb for the treatment of five types of cancer: nonsquamous non-small cell lung cancer, metastatic colorectal cancer, cervical cancer, renal cell carcinoma, and glioblastoma. A biosimilar to bevacizumab, the agent is the first such drug approved for the treatment of cancer.
- |||||||||| Zirabev (bevacizumab biosimilar) / Pfizer, Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
Journal: Bevacizumab biosimilars: scientific justification for extrapolation of indications. (Pubmed Central) - Apr 3, 2019
Extrapolation of indications for a biosimilar to other eligible indications held by the originator, in the absence of direct clinical comparison, frequently forms part of the regulatory judgment. Herein, we consider the evidence required to demonstrate biosimilarity for bevacizumab biosimilars, with particular focus on the rationale for extrapolation across oncologic indications.
- |||||||||| Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Trial completion, Metastases: Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - Sep 18, 2015
P3, N=642, Completed,
In Europe, SB3, a trastuzumab biosimilar, is approved for use as well as two rituzimab biosimilars, truxima and rixathon. Active, not recruiting --> Completed
- |||||||||| Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Enrollment closed, Trial primary completion date, Metastases: Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - Apr 29, 2015
P3, N=642, Active, not recruiting,
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2015 --> Jun 2015
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