Biocon gains on UK health agency’s marketing nod to subsidiary for ophthalmic biosimilar

Earlier in this month, Eris Lifesciences has signed a definitive agreement with Biocon Biologics to acquire its Branded Formulations’ India (BFI) business units of nephrology and dermatology.

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The share price of Biocon gained nearly a percent in early trade on November 15 after its subsidiary Biocon Biologics announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, has granted the marketing authorisation for Yesafili, a biosimilar of Aflibercept.

At 9:21am, Biocon was quoting Rs 229.30, up Rs 1.95, or 0.86 percent, on the BSE.

In September, Yesafili received the marketing authorisation from the European Commission (EC) for markets across the European Union (EU).

The ophthalmology product is used in 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) and has comparable quality, safety, and efficacy to Eylea, the company said.

“The MHRA approval 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,” said a company spokesperson.

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Earlier in this month, Eris Lifesciences had signed a definitive agreement with Biocon Biologics to acquire its Branded Formulation India (BFI) business units of nephrology and dermatology.

The deal consideration is Rs 366 crore, inclusive of working capital conveyed as part of the deal. It will be funded partly through debt financing. The transaction is expected to achieve financial closure by the end of 2023.

The company reported a two-fold year-on-year rise in consolidated net profit at Rs 172.7crore for the July-September quarter of the current financial year. The company had reported a profit of Rs 81.8 crore in the same period of the previous year.

Revenue came in at Rs 3462.3 crore, up 49.2 percent from the year-ago quarter of Rs 2,319.7 crore. Foreign research firm HSBC has maintained the ‘hold’ rating on the stock and cut the target price to Rs 245 from Rs 270 per share.

It was a lacklustre Q2 when biosimilar sales saw muted 6.2 percent QoQ growth, while improved channel access is likely to raise volume for Adalimumab.

The FDA clearance of pending GMP issues at the Malaysia plant is the next catalyst, it added.