Category: BAT1706

Sandoz Enters into a Commercialization and License Agreement with Bio-Thera to Commercialize BAT1706, a Proposed Biosimilar Avastin (bevacizumab)

Shots: Bio-Thera to receive an up front, milestones along with royalties on product sales & will be responsible for the development, manufacturing, supply of BAT1706 Sandoz to get rights for the commercialization of the therapy upon approval in the US, EU, Canada, and other countries. Bio-Thera’s BAT1706 has completed extensive biosimilar studies, including a global […]

Bio-Thera Solutions Reports the US FDA’s Acceptance of BLA for BAT1706 (Proposed Biosimilar to Avastin)

Shots: The BLA submission is based on data from P-III clinical comparison study that demonstrated BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety, and immunogenicity. The anticipated BsUFA date is Nov 27, 2021 The BLA seeks approval of BAT1706 for mCC in combination with fluorouracil-based CT, 1L treatment for nsq. NSCLC, recurrent […]

BeiGene Signs a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

Shots: Bio-Thera to receive $165M upfront, regulatory, and commercial milestones and is eligible to receive royalties on sales of the product. BeiGene to get the right to develop, manufacture, and commercialize BAT1706 in China, including Hong Kong, Macau, and Taiwan while Bio-Thera will retain rights for the therapy outside the licensed territory The NMPA has […]