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news.Avesthagen has completed the manufacturing of the clinical grade material of its first biosimilar molecule for anaemia treatment - AVDESP (biosimilar to Darbepoetin alfa), which will now be moving into clinical trials.
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The drug substance batches for AVDESP, which have been developed by Malaysia’s biopharma CMO – Inno Biologics, will be used to conduct clinical trials after formulation of the drug product in India.
Avesthagen has signed a signed a letter of intent with Inno Biologics for the commercial manufacture of the two biosimilars- AVDESP and AVENT.
AVDESP is indicated for the treatment of specific types of anaemia, such as anaemia associated with chemotherapy/dialysis, where the treatments extend for longer periods of time.
As Darbepoietin alfa has a longer biological half-life compared to recombinant erythropoietin, the frequency of injections necessary to maintain the desired levels of systemic haemoglobin are reduced.
Avesthagen founder and CMD Villoo Morawala-Patell said the company has a rich pipeline of biosimilars, four of which are already through the RCGM (Indian Regulatory body) for conducting clinical trials.
"We foresee Inno Biologics playing an important role in meeting Avesthagen’s goals in getting biosimilars quickly to the market," Morawala-Patell said.