Sandoz in oncology biosimilar deal with China’s Bio-Thera
The biosimilar is a recombinant humanized monoclonal IgG1 antibody that targets vascular endothelial growth factor (VEGF), a key mediator of angiogenesis in cancer, and is used in combination with other treatments, said the partners.
Guangzhou, China based Bio-Thera will maintain responsibility for development and manufacturing, Sandoz will have the right to commercialize the medicine upon approval in the US, Europe, Canada and selected other countries.
According to the terms of the agreement, the Chinese company will receive an upfront and milestone payments and is entitled to receive profit share payments in the partnered territory.
A spokesperson for Sandoz, a division of pharma giant, Novartis, told us about the rationale behind its interest in BAT1706: "Besides being an important offering in its own right, a major reason is that this product, once launched, would complement and build on our leading off-patent oncology portfolio."
That portfolio comprises four marketed oncology biosimilars and over 50 generic medicines worldwide.
Sandoz said its sees external collaborations as complementary to its internal programs, with "an appropriate strategic balance enabling us to drive patient access by delivering portfolio breadth, balancing risks and costs and positioning us to play a leading role in the future biosimilar market.”
Bio-Thera has been busy of late.
In August, the Chinese firm and UK listed, Hikma Pharmaceuticals, inked a pact to commercialize ustekinumab biosimilar product, BAT2206, which is indicated for the treatment of autoimmune diseases such as active psoriatic arthritis.
Meanwhile, April this year saw Bio-Thera sign off on an agreement with Biogen on the development, manufacture and commercialization of another Bio-Thera biosimilar product, BAT1806.
Results published in June this year from a Phase 3 study of that monoclonal antibody, a proposed biosimilar referencing Actemra/RoActemra (tocilizumab), showed equivalent efficacy and a comparable safety profile in patients with moderate-to-severe rheumatoid arthritis.
In the deal, Biogen gained exclusive regulatory, manufacturing, and commercial rights to BAT1806 in all countries excluding China (including Hong Kong, Macau, and Taiwan), allowing the Cambridge, Massachusetts company to expand its global biosimilars footprint.
And, in June this year, a report from GlobalData in June suggested that Bio-Thera potentially could have the first golimumab biosimilar to gain approval in China and Europe.
The prediction came as Bio-Thera initiated a Phase 3 trial of BAT2506 in China and Eastern Europe.
Bio-Thera and another company, Reliance Life Sciences, are the only two firms investigating golimumab biosimilars in Phase 3 trials, according to the data provider. Reliance is conducting a Phase 3 study in India.
“BAT2506 is the only golimumab biosimilar to initiate a Phase III trial in multiple countries and is expected to reap the maximum benefits of early entrant market penetration,” commented Prashant Khadayate, pharma analyst at GlobalData, at the time.