Hot Pursuit     13-Nov-23
Biocon's subsidiary receives UK’s MHRA approval for Aflibercept biosimilar
Biocon said that its subsidiary Biocon Biologics has received marketing authorization from MHRA, Medicines and Healthcare products Regulatory Agency in the UK, for YESAFILI, a biosimilar of Aflibercept.

In September, YESAFILI had received marketing authorization approval from the European Commission (EC) for the European Union (EU).

YESAFILI, an ophthalmology product, is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). It is highly similar to the reference product Eylea (aflibercept).

According to IQVIA data, Aflibercept brand sales in UK were USD 790 million (MAT June 2023).

The company’s spokesperson stated: “We are very pleased to receive the MHRA approval for YESAFILI®, biosimilar Aflibercept, which will enable us to address the needs of patients impacted by macular degeneration and diabetic retinopathy, in the UK. This approval will expand our biosimilar offerings to patients across the globe, building on our oncology and diabetes product portfolios."

Biocon is an innovation led global biopharmaceuticals company, engaged in the production of therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development.

The company’s consolidated net profit surged 167.8% to Rs 125.6 crore in Q2 FY24 as compared with Rs 46.9 crore in Q2 FY23. Revenue from operations jumped 49.26% to Rs 3,462.3 crore in Q2 FY24 as compared with Rs 2,319.7 crore posted in corresponding quarter last year.

The scrip had declined 3.17% to end at Rs 227.35 on the BSE today.

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