Lucentis Biosimilars
Lucentis (ranibizumab) is a monoclonal antibody fragment that acts to inhibit the process of angiogenesis. It is used in the treatment of several disorders of the eye, including age-related macular degeneration. Utilizing the same scaffold as Avastin (bevacizumab), a preceding antibody therapy, it targets vascular endothelial growth factor (VEGF).
The emergence of biosimilars in the biologics drug market is set to improve patient access to life-saving drugs. Lucentis biosimilars have the potential to allow more patients to receive advanced ophthalmic care. However, biosimilar development has various hurdles that can hinder the process, including technical challenges and tight regulations. Demonstrating biosimilarity to the innovator product is a complex process.
At Sartorius, we have supported the development of over 200 biosimilars, many of which have achieved regulatory approval. Our portfolio of ready-to-use assays and comprehensive analysis packages can assist you at all stages of your biosimilar project.
Sartorius delivers comprehensive solutions for the analysis and comparability of your biosimilar. Designed to comply with regulatory requirements, our assays support the development and production of Lucentis biosimilars.
Uncover valuable insights into your biosimilar
Accelerate development times
Meet regulatory requirements
Boost confidence in your product
Limit the risks associated with biosimilar development
Characteristics of Lucentis
Lucentis was initially approved for wet age-related macular degeneration. Its uses have expanded since then, and it is now used to treat macular edema, myopic choroidal neovascularization, and diabetic retinopathy.
Lucentis is administered by injection directly into the eye. It exerts its clinical effects by inhibiting the abnormal growth of blood vessels in the retina, which can leak and cause vision loss.
Lucentis consists of a fragment of Avastin, another anti-VEGF monoclonal antibody. Modifications to the structure were designed to make Lucentis more suitable for the treatment of eye disorders.
Lucentis binds VEGF, an angiogenic growth factor that binds to receptors on endothelial cells. This binding stimulates intracellular signaling that triggers the formation of new blood vessels.
As well as promoting the growth of new blood vessels, VEGF also makes blood vessels more permeable, which can cause them to become leaky. In the eye, both functions can cause damage to the retina, leading to ocular disorders.
Thus, by binding VEGF and blocking its signaling, anti-VEGF agents like Lucentis act to prevent the abnormal growth of blood vessels, preventing further damage to the retina and worsening vision.
We have a range of assays for anti-VEGF biosimilar candidates. Developed initially to support Avastin biosimilarity studies, many of these pipelines have been adapted for Lucentis. We have also developed new assays specifically for the analysis of Lucentis biosimilars.
Assay Types
Physicochemical and structural characterization is a crucial step in determining the potential biological activity, stability, and safety of your biosimilar.
Our versatile platform of physicochemical methods provides the basis for your comparability study. With options suited for clone selection through to formal comparability, we can build detailed insights into the properties of your biosimilar.
The combination of our off-the-shelf physicochemical and structural analyses and our binding and bioassays allows you to evaluate the structure-function relationship and ticks the regulators’ box for orthogonal comparability.
Accurate, quantitative, and robust biological assays are essential for the in vitro characterization of Lucentis biosimilars. Bioassays help us infer the in vivo efficacy of potential therapeutic compounds.
We offer a Lucentis VEGF Neutralization Bioassay, which uses a cell line expressing a reporter construct that emits a signal when VEGF binds to its receptor. The addition of Lucentis neutralizes this effect, and its efficacy can be quantified by luminescence readout. Sample results are reported as a relative potency measurement against the reference standard material.
Early characterization of the binding of Lucentis(ranibizumab) to VEGF is critical to the long-term success of the product.
We offer both ELISA and surface plasmon resonance (SPR) VEGF binding assays to analyze Lucentis biosimilars. Our competition ELISA reports the relative binding of biosimilar and innovator Lucentis material to a number of VEGF isoforms as a percentage of a designated reference lot, with comprehensive parallelism assessments. Our SPR platform reports full kinetic data for the high-affinity interaction between Lucentis and SPR, including Affinity Constants (KD), with the association or “on” rate (Ka) and dissociation rate (Kd) or “off” rate. The data is also evaluated to generate relative binding and parallelism assessments.
