Indian generics maker Cadila Pharmaceuticals Ltd (Cadila) has launched two new similar biologics in the country: Bevaro (bevacizumab) and Ritucad (rituximab).
Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers including colorectal, lung, breast, glioblastoma, kidney and ovarian cancers. The originator product, Avastin, is sold by Roche/Genentech.
On 22 July 2020, Cadila, which is one of the largest private pharmaceutical companies in India, announced the launch of their bevacizumab similar biologic, Bevaro, in the country. The drug will be available in a single dose vial at strengths of 100 mg and 400 mg.
Just a few days later, the company announced the launch of their similar biological of rituximab, to be sold under the trade name Ritucad.
Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection, and autoimmune disorders such as rheumatoid arthritis. The originator product by Genentech is sold under the brand-name Rituxan.
The World Health Organization recently prequalified its first biosimilar version of rituximab (CT‑P10) from Celltrion [1].
Cadila’s similar biologic, Ritucad, will be available in a single dose vial at 100 mg and 500 mg strengths.
Cadila has also been working on a pegfilgrastim similar biologic, which is used to stimulate neutrophil production in patients undergoing chemotherapy [2].
Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘similar biologics’ approved in India might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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References
1. GaBI Online - Generics and Biosimilars Initiative. WHO prequalifies first rituximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 11]. Available from: www.gabionline.net/Biosimilars/General/WHO-prequalifies-first-rituximab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Cadila and Kalbe advancing biosimilar ambitions [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 11]. Available from: www.gabionline.net/Biosimilars/General/Cadila-and-Kalbe-advancing-biosimilar-ambitions
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Source: Cadila Pharmaceuticals Ltd
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