Shilpa Biologicals gets NoC to conduct trials of biosimilar Aflibercept

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.

The Drug had global sales or appx $9.38 billion in 2021 and is amongst the top ten drugs today, growing at 19% pa. The biosimilar product at SBPL is part funded through the Biotechnology Industry Research Assistance Council (BIRAC) grants and developed at its integrated Dharwad facility.

"The Company intends to ensure global accessibility to the product via differentiated pricing and formulations/delivery mechanisms," the company said in a BSE filing.

Biosimilar Aflibercept is the second biosimilar product from SML that has entered the clinical trial phase after Biosimilar Adalimumab.

SML has made significant investments in setting up a High end, Flexible Biologics facility in SBPL, Dharwad to cater to the requirements of the fast-growing biologics field, that include the DNA vaccine, adenoviral, subunit vaccines, Monoclonal antibodies & fusion proteins. 

Read also: Shilpa Biologics, Mylab ink pact to enter vaccine, therapeutics segment

Shilpa Medicare Limited started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India.

The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

Read also: Shilpa Medicare clears USFDA review for Dabaspet facility