Tags : Proposed Biosimilar

Alvotech Reports the US FDA and EMA’s Acceptance of AVT02

Shots: The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA has accepted for review an MAA for AVT02 with an EMA decision anticipated in the Q4’21 The filings were based on AVT02-GL-101 & AVT02-GL-301 studies demonstrating a high degree of […]Read More

Samsung Bioepis Initiates P-I Study of SB16 Proposed Biosimilar to

Shots: The P-I study assesses the PK/PD, safety, tolerability of SB16 (denosumab) vs Prolia in 168 healthy male volunteers for osteoporosis. The study will be 3 arms study that involves dosing with SB16 either the EU or US-sourced Prolia The proposed biosimilar references Amgen’s Prolia which was approved in 2010 for osteoporosis with a high […]Read More

Bio-Thera Initiates P-I Study of BAT2206 Proposed Biosimilar to Stelara

Shots: The first patient has been dosed in a P-I clinical study to compare the PK and safety of BAT2206, a proposed biosimilar to Stelara (ustekinumab) to US/EU-sourced reference product in healthy volunteers The company is expected to enroll 270 healthy volunteers. BAT2206 represents the fifth biosimilar of Bio-Thera’s portfolio that has advanced into clinical […]Read More

Samsung Bioepis Reports the Initiation of P-III Study for SB15

Shots: The P-III study will compare the efficacy, safety, PK, and immunogenicity between SB15 and Eylea in 446 patients with neovascular age-related macular degeneration The company has two ophthalmology biosimilar candidates in clinical development, SB11 (ranibizumab) and SB15 (aflibercept). On May 18, 2020, Samsung Bioepis reports 24-week interim results from a P-III study of SB11 […]Read More

Revance and Mylan to Advance Development Program for a Proposed

Shots: The two companies will advance the development program of a proposed biosimilar to BOTOX and BOTOX Cosmetic (onabotulinumtoxinA), under 351(k) pathways. The US FDA’s feedback during BIAM indicated that the 351(k) regulatory pathways for an onabotulinumtoxinA product is viable Following the advancement of the program, Revance will receive $30M as milestones and is eligible […]Read More

Biocon and Mylan Report the US FDA Acceptance of BLA

Shots: The US FDA has accepted the BLA for Mylan’s MYL-1402O, a proposed biosimilar to Avastin (bevacizumab) for review under the 351(k)pathway with its anticipated BsUFA date as Dec 27, 2020 The BLA is based on P-III study assessing proposed biosimilar bevacizumab vs Avastin along with CT for 18wks. in 671 patients with stage 4 […]Read More

Bio-Thera Reports NMPA’s Acceptance of IND for BAT2206 Proposed Biosimilar

Shots: Bio-Thera to initiate P-I study to evaluate the PK and safety study of BAT2206 (proposed biosimilar) vs Janssen’s Stelara (ustekinumab) US & EU-sourced in normal healthy candidates The clinical study will enroll ~ 270 healthy volunteers. The initiation of the study implies Bio-Thera’s commitment to develop & commercialize biosimilars for patients across the globe […]Read More

NeuClone Reports Dosing of NeuLara (proposed biosimilar, ustekinumab) in P-I

Shots: Australian Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme is responsible for conducting the NeuLara P-I trial and is being conducted across 200 healthy volunteers assessing PK and safety of US- and EU-sourced Stelara NeuClone’s NeuLara is the second biosimilar in pipeline to enter in clinical development and is developed in partnership with […]Read More

Polpharma Signs an Exclusive Worldwide Commercialization Agreement with Sandoz for

Shots: Sandoz to get WW rights to distribute & commercialize proposed biosimilar natalizumab in all markets following its approval. Polpharma Biologics will be responsible for development, manufacturing and supply of proposed biosimilar natalizumab The focus of the agreement is to expand Novartis/Sandoz’s portfolio across small molecules, complex generics, biosimilars, and innovator therapies with the addition […]Read More