September 17, 2021 The US Food and Drug Administration (FDA) has announced the approval of Byooviz (ranibizumab-nuna) as the first biosimilar of Lcentis (ranibizumab).
This is a product to treat certain eye diseases and conditions, including wet age-related macular degeneration (AMD), a cause of vision loss and blindness in Americans 65 years of age and older.
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Byooviz is also approved for the treatment of macular edema following retinal vein occlusion and myopic choroidal neovascularization, a sight-threatening complication of myopia.
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DEFINITION
A biosimilar is a biological product that is approved based on data showing that it is very similar to an FDA-approved biological product (Biologics) (reference product) and has no differences. clinically meaningful differences in safety, purity and potency, in addition to meeting other criteria required by law.
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Biological drugs (Biologics) are drugs that are essentially proteins or protein fragments (natural or synthetic). Unlike other drugs, biological drugs are produced from living organisms such as yeast, bacteria or animal cells. Immunotherapy and targeted therapy are examples of biological drugs used in cancer treatment.
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Corresponding to some original biological drugs there may be one or more biosimilar drugs. Biosimilars are structurally similar but not identical to the original drug. Biosimilar drugs have similar mechanisms of action, with almost no significant differences from the original drug. This means that biosimilars are recognized as safe and effective as the original biologic. Both drugs are produced from living organisms.
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Patients can expect the same safety and effectiveness from the biosimilar during treatment as from the reference product.
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SHARINGS
Sarah Yim, M.D - Director of the FDA Center for Biologics and Biosimilars Therapeutics Research and Evaluation (Biologics and Biosimilars) said:
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“Today's approval provides another treatment option for millions of people with vision loss and is another step forward in our commitment to providing access to safe, effective biologics. efficiency and high quality”
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“Continuing to increase the number of biosimilar approvals is an important part of our effort to provide access to more treatment options for patients, increase competition and reduce costs.”
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CONTENT OF SHARINGS
Vascular age-related macular degeneration destroys the sharp, central vision needed to see clearly and can affect daily activities such as reading, driving and watching television.
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Most cases of the disease will have a high risk of permanent vision loss (blindness). There are two types of AMD - dry and wet. While dry AMD is more common, wet AMD leads to vision loss at a faster rate. Both macular edema and thyroid neovascularization can also lead to visual impairment.
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FDA approval of Byooviz was based on a review of data including structural and functional characteristics; compare clinical effectiveness and evaluate safety; Byooviz demonstrated immunogenicity similar to Lucentis.
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To date, the FDA has approved 31 biosimilars, including one biosimilar that can be used interchangeably to treat a variety of health conditions.
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SIDE EFFECTS
Using Byooviz may cause serious side effects, including:
+ Endophthalmitis (infection inside the eye) and retinal detachment; glaucoma and thromboembolism.
+ The most common side effects of byooviz include conjunctival hemorrhage (broken blood vessels), eye pain, vitreous floaters (black spots passing through the eye), and increased intraocular fluid pressure.
The FDA has approved Byooviz for Samsung Bioepis.
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Source of article:
Translator: Hai Anh – Phacogen Institute of Technology;
(Biotechnology Engineer - Hanoi University of Science and Technology)
