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Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Angle-closure glaucoma, or closed-angle glaucoma, is an eye condition where the iris bulges out and blocks the iridocorneal angle, resulting in a buildup of aqueous humor and increased intraocular pressure. Immediate medical attention is necessary due to the sudden onset of symptoms. The treatment for angle-closure glaucoma includes short-term and long-term approaches. Short-term treatment involves using eye drops like pilocarpine to lower intraocular pressure by increasing aqueous humor...
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Open Angle Glaucoma: Treatment01:27

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In open-angle glaucoma, the iridocorneal angle remains open, but the trabecular meshwork becomes stiff, slowing down the outflow of aqueous humor. This causes a buildup of aqueous humor in the anterior chamber, leading to a sudden increase in intraocular pressure. The treatment for open-angle glaucoma focuses on reducing the elevated intraocular pressure by either decreasing the secretion of aqueous humor or increasing its outflow.
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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Biosimilar Versus Innovator Ranibizumab in Myopic CNVM: Comparative Real-World Outcomes- The BRIM Study.

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Biosimilar ranibizumab (Razumab) is as effective and safe as the innovator version (Lucentis) for treating myopic choroidal neovascularization (mCNVM). Both treatments showed similar improvements in vision and retinal thickness over 12 months.

Keywords:
anti VEGFbiosimilar ranibizumabmyopiamyopic CNVMranibizumab

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Area of Science:

  • Ophthalmology
  • Retinal Diseases
  • Pharmacology

Background:

  • Myopic choroidal neovascularization (mCNVM) is a leading cause of vision loss in high myopia.
  • Intravitreal anti-vascular endothelial growth factor (VEGF) therapy is the standard treatment for mCNVM.

Purpose of the Study:

  • To compare the efficacy and safety of biosimilar ranibizumab (Razumab) versus innovator ranibizumab (Lucentis/Accentrix) in treating mCNVM.
  • To evaluate visual and anatomical outcomes, as well as safety profiles, of both ranibizumab formulations.

Main Methods:

  • Retrospective, multicenter study of treatment-naïve mCNVM patients (n=80) from January 2021 to December 2023.
  • Patients received intravitreal injections of innovator or biosimilar ranibizumab under a pro re nata (PRN) protocol.
  • Outcomes included changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP), injection frequency, and safety over a minimum 12-month follow-up.

Main Results:

  • Both groups showed significant BCVA improvement and CMT reduction at 12 months (p > 0.05).
  • Mean BCVA increased from approximately 51-52 ETDRS letters to 64.5 ETDRS letters in both innovator and biosimilar groups.
  • CMT decreased from over 315 µm to approximately 270 µm in both groups. Injection frequency, IOP, and safety profiles were comparable between the two ranibizumab formulations.

Conclusions:

  • Biosimilar ranibizumab (Razumab) demonstrated non-inferior visual and anatomical outcomes compared to innovator ranibizumab (Lucentis/Accentrix) for mCNVM treatment.
  • The safety profile and treatment burden were similar between the biosimilar and innovator ranibizumab groups.
  • These findings support the use of biosimilar ranibizumab as a viable therapeutic option for mCNVM.