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9 Diseases |  |
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58 News |  |
- Changes in US payer biosimilar coverage policies of granulocyte colony-stimulating factor products () - Apr 9, 2024 - Abstract #AMCP2024AMCP_174;
In both cases, average time to policy addition was about 4 months after FDA approval. Further, pegfil- grastim policies had more updates to the preferred product status than filgrastim policies, possibly because of more pegfilgrastim biosimilars being approved and marketed.
- | Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Biosimilar launch, Journal, Real-world evidence, Real-world: Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch. (Pubmed Central) - Nov 29, 2023
It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity.
- | Ziextenzo (pegfilgrastim-bmez) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost-effectiveness of granulocyte colony-stimulating factors (G-CSFs) for the prevention of febrile neutropenia (FN) in patients with cancer. (Pubmed Central) - Sep 24, 2023
The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity. Biosimilar filgrastim and pegfilgrastim as primary prophylaxis are cost-effective approaches to avoid FN events in patients with BC, NSCLC, or NHL at intermediate risk for FN in Austria, France, and Germany.
- | Ziextenzo (pegfilgrastim-bmez) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
Retrospective data, Journal: Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation. (Pubmed Central) - Jun 14, 2023
This prospective cohort study compared Italian patients with MM who received BIO/PEG post-ASCT with data collected retrospectively from historical control groups from the same center who received either filgrastim-sndz (BIO/G-CSF) or pegfilgrastim (PEG; originator)...Patients on BIO/PEG had less frequent grade 2-3 diarrhea (5.5%) compared with BIO/G-CSF (22.5%) or PEG (21.9%); grade 2-3 mucositis was most frequent in the BIO/G-CSF group. In conclusion, pegfilgrastim and its biosimilar displayed an advantageous efficacy and safety profile compared with biosimilar filgrastim in patients with MM post-ASCT.
- || Ziextenzo (pegfilgrastim biosimilar) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
Review, Journal: A review of the totality of evidence supporting the development and approval of a pegfilgrastim biosimilar (LA-EP2006). (Pubmed Central) - Jun 19, 2022
Clinical studies in a sensitive patient population also demonstrated similar efficacy, safety, and immunogenicity between Sandoz biosimilar pegfilgrastim and the reference biologic. The totality of evidence confirms that Sandoz biosimilar pegfilgrastim matches the reference biologic and will therefore provide equivalent efficacy and safety in all eligible indications.
- || Ziextenzo (pegfilgrastim biosimilar) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
P1 data, PK/PD data, Retrospective data, Journal: Meta-analysis of Pharmacokinetic/Pharmacodynamic Results of 3 Phase 1 Studies with Biosimilar Pegfilgrastim. (Pubmed Central) - Feb 23, 2022
This meta-analysis of 3 phase 1 studies supports PK/PD similarity of Sandoz biosimilar pegfilgrastim to US- and EU-reference pegfilgrastim. No clinically meaningful differences in safety or tolerability were observed.
- || Ziextenzo (pegfilgrastim biosimilar) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
Clinical, PK/PD data, Journal: A large multi-center, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics. (Pubmed Central) - Jul 30, 2021
Sandoz biosimilar pegfilgrastim demonstrated pharmacokinetic and pharmacodynamic similarity to both US- and EU-reference biologics. No meaningful differences in safety, local tolerability, and immunogenicity were identified.
- Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche, Udenyca (pegfilgrastim biosimilar) / Coherus
[VIRTUAL] Incremental cost-effective ratio (ICER) analysis of pegfilgrastim biosimilars: a pharmacoeconomics study () - Dec 26, 2020 - Abstract #ASHP2020ASHP_3368;
This allowed for a comparison of agents that were biosimilar but not therapeutically interchangeable since they do not meet any additional requirements compared to Neulasta® and would need to be evaluated in a new study to gain that status. Regardless, defining the two agents in terms of an ICER allows for a quick and easy comparison that can be used to determine the cost effectiveness of FDA approved biosimilars.
- ||| Ziextenzo (pegfilgrastim biosimilar) / Novartis, Rixathon (rituximab biosimilar) / Kyowa Hakko Kirin, Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
Biosimilar launch, Launch Canada: Sandoz Canada launches two new biosimilars Ziextenzo and Riximyo @Novartis #sandozcanada #sandoz #sandoznews #ziextenzo #riximyo #pegfilgrastim #neulasta #rituximab #rituxan https://t.co/YBcRDDOepj (Twitter) - Aug 22, 2020
- || Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
Clinical, PK/PD data, Journal: Proposed biosimilar pegfilgrastim shows similarity in pharmacokinetics and pharmacodynamics to reference pegfilgrastim in healthy subjects. (Pubmed Central) - Nov 19, 2019
PK/PD similarity of Sandoz proposed biosimilar pegfilgrastim and reference pegfilgrastim was confirmed. No clinically meaningful differences in safety, tolerability and immunogenicity were observed in healthy subjects.
- ||| Ziextenzo (pegfilgrastim biosimilar) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
New #AusPAR for #Ziextenzo [#Pegfilgrastim] for treatment of #post-chemotherapy neutropenia: https://t.co/BTdDbHSuqS (Twitter) - Nov 17, 2019
- ||| Ziextenzo (pegfilgrastim biosimilar) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
Novartis gets approval for its biosimilar to Neulasta called Ziextenzo; making it the 3rd biosimilar version of Neulasta - others made by Coherus and mylan. These are sold in the US at a 33% discount. Amgens Neulasta sales down 32% in 2019. https://t.co/v8Z0nhr1Ah (Twitter) - Nov 6, 2019
- |||| Ziextenzo (pegfilgrastim biosimilar) / Novartis
Clinical, FDA event: Sandoz’s Ziextenzo (biosimilar, pegfilgrastim) Receives the US FDA’s Approval to Decrease the Incidence of Febrile Neutropenia @Sandoz_Global https://t.co/gXyDVaBE7Y (Twitter) - Nov 5, 2019
- | Ziextenzo (pegfilgrastim biosimilar) / Novartis
Clinical, P3 data, Journal: Safety analysis of proposed pegfilgrastim biosimilar in Phase I and Phase III studies. (Pubmed Central) - Aug 21, 2019
No clinically meaningful differences in safety, tolerability and immunogenicity were observed in healthy subjects. No differences in adverse events were found between Sandoz proposed biosimilar and reference pegfilgrastim, notwithstanding some differences between HVs and BC patients.
- | Ziextenzo (pegfilgrastim biosimilar) / Novartis
Journal: LA-EP2006: A Pegfilgrastim Biosimilar. (Pubmed Central) - Aug 16, 2019
The tolerability and safety profile of and the incidence of anti-drug antibodies with LA-EP2006 were similar to those of EU-sourced reference pegfilgrastim in this patient population. The role of reference pegfilgrastim in the management of chemotherapy-induced neutropenia is well established and LA-EP2006 provides an effective biosimilar alternative for patients requiring pegfilgrastim therapy.
- | Ziextenzo (pegfilgrastim biosimilar) / Novartis, Zarzio (filgrastim biosimilar) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
Clinical, P3 data, Journal: Proposed biosimilar pegfilgrastim (LA-EP2006) compared with reference pegfilgrastim in Asian patients with breast cancer: an exploratory comparison from two Phase III trials. (Pubmed Central) - Aug 10, 2018
The role of reference pegfilgrastim in the management of chemotherapy-induced neutropenia is well established and LA-EP2006 provides an effective biosimilar alternative for patients requiring pegfilgrastim therapy. LA-EP2006 showed similar clinical efficacy and safety compared with reference pegfilgrastim.
- | Ziextenzo (pegfilgrastim biosimilar) / Novartis, Zarzio (filgrastim biosimilar) / Novartis
Retrospective data, Journal: Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. (Pubmed Central) - May 26, 2018
P3
LA-EP2006 showed similar clinical efficacy and safety compared with reference pegfilgrastim. The current analysis reports data pooled from two independent, multinational, prospective, randomized, controlled, double-blind phase III studies of similar design comparing the safety and efficacy of reference pegfilgrastim with LA-EP2006 in patients with breast cancer receiving myelotoxic (neo)adjuvant TAC (docetaxel, doxorubicin, and cyclophosphamide) chemotherapy and requiring granulocyte colony-stimulating factor...NCT01735175, NCT01516736.
- | Ziextenzo (pegfilgrastim biosimilar) / Novartis, Zarzio (filgrastim biosimilar) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
Journal: A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial. (Pubmed Central) - Nov 3, 2017
Biosimilar pegfilgrastim (LA-EP2006) may benefit oncology patients by offering increased access to biological treatments that may improve clinical outcomes. This means that patients could potentially be treated prophylactically with biologics rather than only after complications have occurred.
- |||| Ziextenzo (pegfilgrastim-bmez) / Sandoz
Trial primary completion date: PROTECT2: Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim (clinicaltrials.gov) - Jul 27, 2017
P3, N=308, Completed, Sponsor: Sandoz
This means that patients could potentially be treated prophylactically with biologics rather than only after complications have occurred. Trial primary completion date: Dec 2013 --> Aug 2013
- | Ziextenzo (pegfilgrastim biosimilar) / Novartis, Zarzio (filgrastim biosimilar) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
Journal: Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. (Pubmed Central) - Mar 9, 2017
Trial primary completion date: Dec 2013 --> Aug 2013 LA-EP2006 and reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety in breast cancer patients receiving chemotherapy.
- ||||| Ziextenzo (pegfilgrastim-bmez) / Sandoz
Trial initiation date: PROTECT2: Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim (clinicaltrials.gov) - Sep 21, 2015
P3, N=308, Completed, Sponsor: Sandoz
LA-EP2006 and reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety in breast cancer patients receiving chemotherapy. Initiation date: Dec 2011 --> Mar 2012
- ||||||| Ziextenzo (pegfilgrastim-bmez) / Sandoz
Trial completion: PROTECT2: Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim (clinicaltrials.gov) - Feb 20, 2014
P3, N=308, Completed, Sponsor: Sandoz
Initiation date: Dec 2011 --> Mar 2012 Active, not recruiting --> Completed
- ||||||| Ziextenzo (pegfilgrastim-bmez) / Sandoz
Trial completion: Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta (clinicaltrials.gov) - Sep 19, 2013
P3, N=318, Completed, Sponsor: Sandoz
Active, not recruiting --> Completed Recruiting --> Completed
- |||||||||| Ziextenzo (pegfilgrastim-bmez) / Sandoz
New P3 trial: Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta (clinicaltrials.gov) - Nov 26, 2012
P3, N=318, Completed, Sponsor: Sandoz
- |||||||||| Ziextenzo (pegfilgrastim-bmez) / Sandoz
New P3 trial: PROTECT2: Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim (clinicaltrials.gov) - Jan 23, 2012
P3, N=308, Completed, Sponsor: Sandoz