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

Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across the US

Shots: Bio-Thera and Intas Pharmaceuticals have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) in the US As per the agreement, Bio-Thera is entitled to receive $21M upfront and an additional $143.5M in development and commercial milestones BAT2506 is an IgG1 monoclonal antibody targeting TNF-alpha,…

ByRidhi RastogiFebruary 10, 2025

NEWS

Bio-Thera Reports the EMA’s MAA Acceptance of BAT2506 (Biosimilar, Simponi)

Shots: The EMA has accepted the MAA of BAT2506, a biosimilar version of Simponi (golimumab) Approval was backed by extensive analytical characterization and biosimilarity of BAT2506 in comparison to US & EU golimumab from P-I trial in healthy subjects, plus P-III trial (vs. EU Simponi) in active PsA pts depicting non-inferior efficacy & comparable…

ByRidhi RastogiFebruary 10, 2025

NEWS

Bio-Thera Reports the EMA’s Approval of Avzivi (Biosimilar, Avastin) for Treating Multiple Indications

Shots: The EMA has granted approval to the company’s Avzivi (bevacizumab), a biosimilar version of Avastin. Sandoz is responsible for marketing the drug across the EU The license and commercialization agreement b/w Bio-Thera and Sandoz was signed in Sep 2021, under which Bio-Thera had the development and manufacturing rights while Sandoz secured the commercialization…

ByDipanshu DixitJuly 30, 2024

NEWS

Bio-Thera Solutions Reports the Initiation of Combined P-I/P-III Study of BAT3306 (Biosimilar, Keytruda)

Shots: Bio-Thera Solutions has commenced the patients dosing under the combined P-I/P-III study evaluating BAT3306, a biosimilar version of Keytruda (pembrolizumab) The trial aims at assessing PK profile, safety & efficacy of BAT3306 vs Keytruda among patients (n=676) with non-squamous non-small cell lung cancer (nsNSCLC) In addition, the company is also developing biosimilars of…

ByDipanshu DixitJuly 25, 2024

NEWS

Bio-Thera Reports the Regulatory Filing Acceptance for BAT2206 (Biosimilar, Stelara) Across the US and EU

Shots: The US FDA and EMA have accepted the BLA & MAA of BAT2206 for treating moderate to severe plaque PsO in adults eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active ulcerative colitis. BLA in China is under review The applications were supported by…

ByDipanshu DixitJuly 24, 2024

NEWS

Bio-Thera Gains the CHMP’s Positive Opinion of Avzivi (Biosimilar, Avastin)

Shots: The CHMP has granted a positive opinion to the company’s Avzivi (bevacizumab), a biosimilar of Avastin to treat metastatic colorectal cancer The opinion was based on a P-I study assessing the PK, safety & immunogenicity of Avzivi vs EU & US reference product among healthy subjects & a P-III confirmatory trial of Avzivi…

ByDipanshu DixitJune 3, 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+

PharmaShots’ Key Highlights of Third Quarter 2021

The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229M The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B,…

BySenior EditorSeptember 30, 2021

INSIGHTS+

Insights+ Key Biosimilars Events of August 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of August, Samsung Bioepis Byooviz (biosimilar, ranibizumab) received EC's…

BySenior EditorSeptember 2, 2021

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

Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across the US

Bio-Thera Reports the EMA’s MAA Acceptance of BAT2506 (Biosimilar, Simponi)

Bio-Thera Reports the EMA’s Approval of Avzivi (Biosimilar, Avastin) for Treating Multiple Indications

Bio-Thera Solutions Reports the Initiation of Combined P-I/P-III Study of BAT3306 (Biosimilar, Keytruda)

Bio-Thera Reports the Regulatory Filing Acceptance for BAT2206 (Biosimilar, Stelara) Across the US and EU

Bio-Thera Gains the CHMP’s Positive Opinion of Avzivi (Biosimilar, Avastin)

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

PharmaShots’ Key Highlights of Third Quarter 2021

Insights+ Key Biosimilars Events of August 2021

Contact US

FOLLOW US