Shilpa Biologicals gets NoC to conduct trials of biosimilar Aflibercept
Biosimilar Aflibercept is the second biosimilar product from SML that has entered the clinical trial phase after Biosimilar Adalimumab.;
Karnataka: Shilpa Medicare has recently announced that the company's wholly-owned subsidiary, Shilpa Biologicals Private Limited (SBPL), has received a NoC from RCGM, Dept of Biotechnology to approach the Drugs Controller General of India (DCGI) to conduct clinical studies for its Biosimilar Aflibercept – a first from an Indian company.
The product is a biosimilar version of EYLEA of Regeneron for which currently there is no other biosimilar version on the Indian market.
The Company intends to now approach the DCGI to conduct local and global Human Clinical studies to cater to the burgeoning Wet Age-Related Macular Degeneration (wAMD), Diabetic Retinopathy, Diabetic Macular Edema (DME) and Macular Edema following Retinal Vein Occlusion markets in India and across the globe. India has amongst the highest incidences of the above indications and the market is under-catered to by current therapies.
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