Bio-Thera Reports the US FDA’s BLA Acceptance of BAT2506 (Biosimilar, Simponi)

Shots: FDA has accepted BLA for BAT2506, a biosimilar of Simponi (golimumab) for all approved doses, formulations, & indications of reference product, with a request for interchangeability (BsUFA: May 16, 2026) BLA was backed by extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects,…

ByRidhi RastogiJuly 17, 2025

NEWS

Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 (Biosimilar, Stelara) & BAT2506 (Biosimilar, Simponi) Across the Southeast Asia

Shots: Bio-Thera and Dr. Reddy’s have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) & BAT2206, a biosimilar version of Stelara (ustekinumab) As per the agreement, Bio-Thera will handle the development, manufacturing, and supply of BAT2206 & BAT2506, while Dr. Reddy’s will manage regulatory approvals &…

ByDipanshu DixitMarch 28, 2025

NEWS

Alvotech and Advanz Pharma Reports the EMA’s MAA Acceptance of AVT05 (Biosimilar, Simponi)

Shots: The EMA has accepted the MAA of AVT05, biosimilar version of J&J's Simponi & Simponi Aria (golimumab), for the treatment of several chronic inflammatory diseases, with the decision expected in Q4’25 Alvotech, in Apr 2024, reported top-line data from a confirmatory trial of AVT05 vs Simponi in patients with moderate to severe rheumatoid arthritis,…

ByDipanshu DixitNovember 4, 2024

NEWS

Bio-Thera Collaborates with STADA for the Commercialization of BAT2506 (Biosimilar, Simponi)

Shots: Bio-Thera and STADA have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) Under the collaboration, Bio-Thera is entitled to receive a $10M upfront and an additional $147.5M development and commercial milestones upon certain conditions fulfilment Furthermore, Bio-Thera will handle the development, manufacturing and supply activities of…

ByDipanshu DixitMay 28, 2024

INSIGHTS+

Disease of the Month- Juvenile Arthritis

Shots: To keep our readers acquainted with several disease conditions, ongoing trials, and available treatment options, PharmaShots brings every month a detailed take on a particular disease after thorough research Continuing the series for the disease of the month, PharmaShots brings this month a summary of Juvenile arthritis, an autoimmune inflammatory disease July is observed…

BySenior EditorJuly 13, 2023

Bio-Thera Reports the US FDA’s BLA Acceptance of BAT2506 (Biosimilar, Simponi)

Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 (Biosimilar, Stelara) & BAT2506 (Biosimilar, Simponi) Across the Southeast Asia

Alvotech and Advanz Pharma Reports the EMA’s MAA Acceptance of AVT05 (Biosimilar, Simponi)

Bio-Thera Collaborates with STADA for the Commercialization of BAT2506 (Biosimilar, Simponi)

Disease of the Month- Juvenile Arthritis

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