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

INSIGHTS+

Insights+ Key Biosimilars Events of January 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. Hence, the providers are more likely to adopt biosimilars as a 'reference…

BySenior EditorFebruary 4, 2021

INSIGHTS+

Insights+ Key Biosimilars Events of December 2020

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. Hence, the providers are more likely to adopt biosimilars as a 'reference…

BySenior EditorJanuary 28, 2021

INSIGHTS+

Insights+ Key Biosimilars Events of November 2020

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. Hence, the providers are more likely to adopt biosimilars as a 'reference…

BySenior EditorDecember 3, 2020

INSIGHTS+

Insights+ Key Biosimilars Events of August 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Mylan with its partner Lupin and Biocon launched Nepexto (biosimilar, etanercept) and Semglee (insulin glargine injection) in Germany & in the US, respectively. Additionally, Formycon and Bioeq planned to initiate P-III MAGELLAN-AMD Trial for its FYB203 (biosimilar,…

BySenior EditorSeptember 3, 2020

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

Insights+ Key Biosimilars Events of January 2021

Insights+ Key Biosimilars Events of December 2020

Insights+ Key Biosimilars Events of November 2020

Insights+ Key Biosimilars Events of August 2020

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