New Biosimilars Approved by FDA for Age-Related Macular Degeneration
Key Takeaways
- The FDA approved two biosimilars to aflibercept for treating AMD and related conditions.
- Biosimilars offer the same safety and efficacy as the reference product Eylea.
- Interchangeable biosimilars can be substituted without consulting the prescriber.
Did You Know?
Introduction to Macular Degeneration and Aflibercept
Age-related macular degeneration (AMD) is a common eye condition affecting the macula, a small spot near the center of the retina. It is a leading cause of vision loss among people aged 50 and older. The FDA has recently approved biosimilars to aflibercept, a drug used to treat AMD, bringing new hope to patients with this condition.
Aflibercept, sold under the brand name Eylea, is an anti-VEGF (vascular endothelial growth factor) therapy used to manage various eye diseases such as AMD, diabetic macular edema, diabetic retinopathy, and macular edema following retinal vein occlusion. The introduction of biosimilars provides more options and potentially lower-cost treatments for these conditions.
What Are Biosimilars?
Biosimilars are highly similar to already approved biological medicines, known as reference products. They have no clinically meaningful differences in safety, purity, or potency and offer more treatment choices while fostering competition in the market. The FDA’s recent approval underscores the reliability and effectiveness of biosimilars in treating complex conditions like AMD.
Newly Approved Biosimilars to Aflibercept
The two newly approved biosimilars are aflibercept-jbvf (Yesafili) and aflibercept-yszy (Opuviz). Both biosimilars have been approved for the same indications as Eylea. This includes the treatment of diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and neovascular AMD.
These biosimilars are administered through intravitreal injection, a procedure where the drug is injected directly into the eye. The FDA has confirmed that these biosimilars can be used interchangeably with the reference product Eylea without any expected change in performance or safety.
What Does Interchangeability Mean?
Interchangeability means that the biosimilar can be substituted for the reference product without the prescriber’s intervention, subject to state pharmacy laws. This is akin to how generic medications are substituted for brand-name drugs. Patients can rest assured that interchangeable biosimilars offer the same safety and efficacy as the original product.
Approval Process and Scientific Evidence
The FDA's approval of Yesafili and Opuviz followed a thorough review of scientific evidence. This included detailed analyses comparing the biosimilars’ physicochemical properties and biological activities to those of Eylea, ensuring they met stringent criteria for similarity.
Additionally, comparative clinical studies were conducted to confirm that these biosimilars had similar safety and efficacy profiles as Eylea. The comprehensive data gathered from these studies supported the FDA’s decision to approve these biosimilars as safe and effective treatment options.
Side Effects and Safety
The side effects and adverse events observed in clinical trials for Yesafili and Opuviz were consistent with those associated with Eylea. This includes potential risks such as eye pain, redness, and increased intraocular pressure, which are common with intravitreal injections.
By providing biosimilars that match the reference product’s safety profile, the FDA ensures that patients can confidently switch to these new treatments without increased risk.
Manufacturers and Global Impact
The FDA granted approval for Yesafili to Biocon Biologics, based in India, and for Opuviz to a collaboration between Samsung Bioepis and Biogen. This approval not only expands the treatment options available in the United States but also emphasizes the global nature of pharmaceutical development and cooperation.
Previously, the FDA approved ranibizumab-nuna (Byooviz), another biosimilar by Biogen/Samsung Bioepis, for treating neovascular AMD and other related conditions, showcasing ongoing advancements in biosimilar therapeutics.
Conclusion: A Step Forward in Eye Care
The approval of biosimilars to aflibercept represents a significant advancement in the treatment of AMD and related conditions. These new options can potentially reduce costs and improve access to effective treatments, providing renewed hope for patients struggling with these vision-threatening diseases.
As biosimilar treatments continue to emerge, the landscape of ophthalmology is set to change, offering more choices and fostering innovation in eye care.
