Category : Biosimilars

Celltrion Presents Real-World Data of Truxima (biosimilar, rituximab) for Diffuse Large B-Cell Lymphoma at EHA 2021

Tuba Khan June 14, 2021

Shots: The new data from the post-approval study evaluates the effectiveness & safety of Truxima (CT-P10) in patients with DLBCL in a real-world setting across Europe Results: @30mos. post-index, 67% had not experienced disease progression with OS (74%), three-quarters patients achieved complete or partial response @30mos., well tolerated with AEs while response rates, survival rates […]

Biosimilars Clinical Trials

Bio-Thera Reports the Initiation of P-III Clinical Trial for BAT2506

Tuba Khan June 9, 2021

Shots: The company has initiated a P-III clinical study to evaluate the efficacy and safety of BAT2506 vs Simponi in ~ 480 volunteers with PsA. Simponi is approved for moderately to severely active RA, active PsA, active AS & UC BAT2506 is the 3rd proposed biosimilar of the company to enter a global P-III study […]Read More

Biosimilars Clinical Trials

Biogen and Bio-Thera Report Results of BAT1806 (biosimilar, tocilizumab) in

Tuba Khan June 3, 2021

Shots: The P-III study involves assesing the safety, efficacy, immunogenicity & PK of BAT1806 vs Actemra/RoActemra (tocilizumab) in 621 patients with the mod. to sev. RA with inadequate response to methotrexate The study met its 1EPs that demonstrated equivalent efficacy and comparable safety profile to the Actemra/RoActemra. The 1EP of the study was ACR20 Biogen […]Read More

Biosimilars

Lupin Reports the US FDA Acceptance of BLA for Pegfilgrastim

Tuba Khan June 3, 2021

Shots: The US FDA has accepted the BLA for a proposed biosimilar to Neulasta (pegfilgrastim) by filing using the 351(k) pathway The BLA submission is based on similarity data from analytical, PK, PD, and immunogenicity studies. The focus is to provide affordable solutions to reduce the disease burden The US FDA filing is the first […]Read More

Biosimilars Clinical Trials

Celltrion Presents One Year Results of Yuflyma (biosimilar, adalimumab) in

Tuba Khan June 3, 2021

Shots: The P-III CT-P17 3.1 trial involves assessing Yuflyma (adalimumab, 40mg, high-concentration formulation, low-volume and citrate-free, q2w, up to 24 wks.) vs reference adalimumab in a ratio (1:1) in 648 patients with active RA The one year data demonstrated comparable efficacy of Yuflyma to reference adalimumab in terms of ACR20/50/70 response rates in patients receiving […]Read More

Biosimilars

Prime Therapeutics Launches MedDrive for Greater Biosimilar Drug Adoption

Tuba Khan May 26, 2021

Shots: Prime Therapeutics launches MedDrive in multiple phases and provide a solution to help Blue Plan clients for greater biosimilar adoption and drug cost-saving strategies Prime helps the Blue Plan clients through a 100% transparent, unbiased PBM model that serves nearly 33M members across 23 Blue Plans Prime and Blue Cross plans to improve the […]Read More

Biosimilars Clinical Trials

BioFactura Initiates P-I Study of BFI-751 (biosimilar, ustekinumab) in Australia

Tuba Khan May 26, 2021

Shots: The company initiate a pivotal PK P-I clinical trial assessing the efficacy of BFI-751 vs Stelara in healthy human volunteers, with the authorization of Ethics Committees in both Australia and New Zealand The primary objective of the study is to compare PK of BFI-751 to US & EU-Stelara following a single dose under the […]Read More

Biosimilars

Zydus Cadila Launches Ujvira (biosimilar, trastuzumab emtansine) for Early and

Tuba Khan May 24, 2021

Shots: Ujvira is made by combining Trastuzumab and a cytotoxic compound Emtansine (DM1) utilizing a stable linker by Antibody Drug Conjugation and is supported by drug development program Ujvira be available in 2 strengths (100 & 60mg) and the therapy will be priced at nearly 80% less than the currently available option in the market […]Read More

Biosimilars

Meiji Reports Results of P-I Study of DMB-3115 (proposed ustekinumab

Tuba Khan May 21, 2021

Shots: The P-I study involves assessing pharmacokinetics, safety, and tolerability of DMB-3115 with its reference products (US- and EU-marketed products) in 296 healthy volunteers at a single site in the EU DMB-3115 showed bioequivalence to the reference and was well tolerated. The reported AEs corresponded with the known safety profile of ustekinumab with no new […]Read More

Biosimilars

Quebec Reports the Intention on Implementing Shift Towards Biosimilars

Tuba Khan May 19, 2021

Shots: Quebec government has stated province intention to shift towards biosimilars and follows the transition policies implemented by British Columbia, Alberta & New Brunswick The expanded use of biosimilars is expected to generate annual savings of $100M for the public drug insurance plan and its insured parties that can be reinvested in healthcare and innovative […]Read More

CytoReason Collaborates with Sanofi to Initiate its Project Utilizing AI Technology for Asthma

Atea Pharma Secures $50M Milestone Payment with Roche in the Development of AT-527 for COVID-19

Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem

BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma

Celltrion Presents Real-World Data of Truxima (biosimilar, rituximab) for Diffuse Large B-Cell Lymphoma at EHA 2021

Bio-Thera Reports the Initiation of P-III Clinical Trial for BAT2506 (biosimilar, golimumab)

Atea Pharma Secures $50M Milestone Payment with Roche in the Development of AT-527 for COVID-19

CureVac Report Results of CVnCoV in Second Interim Analysis of P-llb/lll HERALD Trial to Treat COVID-19

Blueprint Medicines’ Ayvakit (avapritinib) Receives FDA’s Approval to Treat Patients with Advanced Systemic Mastocytosis

MannKind and United Therapeutics Reports the US FDA’s Acceptance of NDA for Priority Review of Tyvaso DPI to Treat PAH and PH-ILD

BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma

BeiGene Reports First Patient Dosing in P-III AdvanTIG-302 Trial of Ociperlimab (BGB-A1217) + Tislelizumab (BGB-A317) to Treat Non-Small Cell Lung Cancer

Category : Biosimilars

Celltrion Presents Real-World Data of Truxima (biosimilar, rituximab) for Diffuse Large B-Cell Lymphoma at EHA 2021

Bio-Thera Reports the Initiation of P-III Clinical Trial for BAT2506

Biogen and Bio-Thera Report Results of BAT1806 (biosimilar, tocilizumab) in

Lupin Reports the US FDA Acceptance of BLA for Pegfilgrastim

Celltrion Presents One Year Results of Yuflyma (biosimilar, adalimumab) in

Prime Therapeutics Launches MedDrive for Greater Biosimilar Drug Adoption

BioFactura Initiates P-I Study of BFI-751 (biosimilar, ustekinumab) in Australia

Zydus Cadila Launches Ujvira (biosimilar, trastuzumab emtansine) for Early and

Meiji Reports Results of P-I Study of DMB-3115 (proposed ustekinumab

Quebec Reports the Intention on Implementing Shift Towards Biosimilars

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PharmaShots Weekly Snapshots (June 14 – 18, 2021)

Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem

BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma

CytoReason Collaborates with Sanofi to Initiate its Project Utilizing AI Technology for Asthma

Category : Biosimilars

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