2022 Biosimilars Diabetes 
Express Pharma
SEPTEMBER 20, 2023
Biocon Biologics has received the European Commission (EC) granted marketing authorization in the European Union (EU) for YESAFILI, a biosimilar of Aflibercept. billion for the 12 months ending December 31, 2022, according to IQVIA. It is highly similar to the reference product Eylea (aflibercept).
European Pharmaceutical Review
JANUARY 17, 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Ximluci ® (ranibizumab), a biosimilar referencing Lucentis®, to help treat a leading cause of blindness globally. A biosimilar for biologic ophthalmic treatments. Manufacture and development of Ximluci ®.
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European Pharmaceutical Review
SEPTEMBER 20, 2022
The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have announced that biosimilar medicines authorised in the European Union (EU) can now be interchanged with their reference medicine or an equivalent biosimilar product. Interchanging biosimilars is an acceptable practise already used by many Member States.
pharmaphorum
JULY 29, 2021
The US regulator will review the drug for both neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular oedema (DME), as well as diabetic retinopathy under a standard review. The post FDA starts review of Roche’s eye disease drug, setting up 2022 verdict appeared first on.
Express Pharma
JULY 23, 2023
Biocon Biologics, a subsidiary of Biocon announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of YESAFILI, an aflibercept biosimilar. billion for the 12 months ending December 31, 2022, according to IQVIA.
pharmaphorum
JUNE 20, 2025
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pharmaphorum
SEPTEMBER 20, 2021
Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. The post FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis appeared first on.
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