Bio-Thera advances bevacizumab and tocilizumab copy biologicals

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Bio-Thera advances bevacizumab and tocilizumab copy biologicals

Biosimilares/Novedades | Posted 01/04/2019 0 Post your comment

China-based Bio‑Thera Solutions (Bio‑Thera) has made a licensing agreement for its bevacizumab copy biological and has started a phase III trial for its tocilizumab copy biological.

Bio-Thera announced on 14 January 2019 that it had reached a licensing agreement with India-based Cipla for its bevacizumab copy biological, BAT1706. Under the agreement Cipla will have exclusive rights to distribute and market the drug in select emerging markets.

Bio-Thera’s BAT1706 is currently in a global phase III study (NCT03329911) in patients with previously untreated advanced non-squamous non-small cell lung cancer. The company says that it intends to file for regulatory approval with China’s National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in 2020.

On 24 January 2019, Bio-Thera announced that it had started dosing rheumatoid arthritis patients in a global phase III trial for its tocilizumab copy biological, BAT1806. The product is one of four Bio-Thera candidates in phase III trials.

The company says that it is developing a portfolio of ‘innovative and biosimilar molecules’ for various cancers, autoimmune and cardiovascular diseases. The Biologics License Application (BLA) for its adalimumab copy biological, BAT1406, was accepted for review by China’s National Medical Products Administration in August 2018 [1]. The company is also pursuing copy biologicals of ustekinumab, secukinumab and golimumab.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Adalimumab copy biologicals accepted for review in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 1]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-copy-biologicals-accepted-for-review-in-China

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Source: Bio-Thera