Ranibizumab biosimilars - Insight, 2022

DelveInsight’s, “Ranibizumab Biosimilars – Pipeline Insight, 2022,” report provides comprehensive insights about 17+ companies and 17+ marketed and pipeline drugs in Ranibizumab Biosimilars pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It covers the marketed and pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered
• Global coverage

Ranibizumab Biosimilars Understanding
Ranibizumab: Overview
Lucentis (Ranibizumab) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. It is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and myopic choroidal neovascularization (mCNV). Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline.
LUCENTIS is indicated for the treatment of patients with:
• Neovascular (Wet) Age-Related Macular Degeneration (AMD)
• Macular Edema Following Retinal Vein Occlusion (RVO)
• Diabetic Macular Edema (DME)
• Diabetic Retinopathy (DR)
• Myopic Choroidal Neovascularization (mCNV)

""Ranibizumab Biosimilars - Pipeline Insight, 2022"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Ranibizumab Biosimilars pipeline landscape is provided which includes the disease overview and Ranibizumab Biosimilars treatment guidelines. The assessment part of the report embraces, in depth Ranibizumab Biosimilars commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Ranibizumab Biosimilars collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights
• The companies and academics are working to assess challenges and seek opportunities that could influence Ranibizumab Biosimilars R&D. The therapies under development are focused on novel approaches to treat/improve Ranibizumab Biosimilars.

Ranibizumab Biosimilars Drugs Chapters
This segment of the Ranibizumab Biosimilars report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Ranibizumab Biosimilars: Marketed Drugs
• Razumab: Intas Pharmaceuticals
Razumab injection is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use and a biosimilar to Ranibizumab. The binding of Razumab to VEGF-A prevents the interaction of VEGF-A with its receptors VEGFR-1 and VEGFR-2 on the surface of endothelial cells and thus inhibit the endothelial cell proliferation, neovascularization and vascular leakage. Razumab has a molecular weight of approximately 48 kilo Daltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. In June 2015, Intas became the first company globally to develop and launch a biosimilar version of Ranibizumab. RAZUMAB™ is manufactured under strict guidelines for sterile use in the eye and is offered as single dose vial, thus reducing the risk of contamination during use. Intas’ ranibizumab, RAZUMAB is a 100 per cent ‘Made in India’ molecule, a feat achieved by the scientists at Intas and unparalleled till date. It was approved by the Drug Controller General of India for the treatment of Neovascular (Wet) Age-related Macular Degeneration (Wet-AMD), Diabetic Macular Edema (DME), Retinal Vein Occlusion (RVO), and Choroidal neovascularization (CNV).

• RanizuRel: Reliance Life Sciences
RanizuRel™ (Ranibizumab) is a recombinant humanized IgG1K isotype monoclonal antibody fragment that selectively binds to inhibit biological activity of human vascular endothelial growth factor A (VEGF-A). It is produced in an E.Coli expression system and has a molecular weight of 48 kilodaltons. RanizuRel™ is indicated in Neovascular (Wet) Age-Related Macular Degeneration (AMD) and administered by intravitreal injection. It is recommended to administer RanizuRel once a month (approximately 28 days). The intravitreal injection procedure should be carried out under controlled aseptic conditions. RanizuRel™ is sterile, preservative-free, and clear colourless to pale yellow solution available in 0.5 mg dose single-use vial.

Ranibizumab Biosimilars Emerging Drugs
• Xlucane: Xbrane
Xlucane is a ranibizumab (Lucentis) biosimilar candidate, a so-called VEGF-A inhibitor, intended to be used to treat a number of serious eye diseases: wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), as well as retinal vein occlusion (RVO). A pivotal phase III study, XPLORE, is being conducted to demonstrate equivalence to Lucentis. In October 2021, a Marketing Authorization Application (MAA) for biosimilar ranibizumab that was submitted by Xbrane co-development and commercialization partner, STADA Arzneimittel AG was validated by the European Medicines Agency (EMA).

• GNR-067: GENERIUM Pharmaceuticals
GNR-067 is a ranibizumab biosimilar being developed by Generium Pharmaceuticals. Ranibizumab binds to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF110. VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion and is thought to contribute to pathophysiology of neovascular AMD, mCNV, DR, DME and macular edema following RVO. The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation. Currently, it is in Phase III stage of clinical trial evaluation to treat wet Age-related Macular Degeneration.
Further product details are provided in the report……..

Ranibizumab Biosimilars: Therapeutic Assessment
This segment of the report provides insights about the different Ranibizumab Biosimilars drugs segregated based on following parameters that define the scope of the report, such as:
• Major Players in Ranibizumab Biosimilars
There are approx. 17+ key companies which are developing the therapies for Ranibizumab Biosimilars.
• Phases
DelveInsight’s report covers around 17+ products under different phases of clinical development like
• Marketed stage products
• Late stage products (BLA filed and Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

• Route of Administration
Ranibizumab Biosimilars pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical.

• Molecule Type

Products have been categorized under various Molecule types such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

• Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Ranibizumab Biosimilars: Pipeline Development Activities
The report provides insights into different therapeutic candidates marketed and in phase III, II, I, preclinical and discovery stage. It also analyses Ranibizumab Biosimilars therapeutic drugs key players involved in developing key drugs.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Ranibizumab Biosimilars drugs.

Report Highlights
• In April 2021, Xbrane Partnered with Bausch & Lomb to enter the US market. In October 2021, a Marketing Authorization Application (MAA) for biosimilar ranibizumab that was submitted by Xbrane co-development and commercialization partner, STADA Arzneimittel AG was validated by the European Medicines Agency (EMA).
• In October 2021, Coherus BioSciences announced the United States Food and Drug Administration (FDA) has accepted for review the 351(k) Biologics License Application (BLA) for CHS-201, a biosimilar candidate of reference product Lucentis® (ranibizumab). The FDA has set a Biosimilar User Fee Act action date for August 2, 2022, and, if approved, Coherus plans to launch the Lucentis biosimilar in the U.S. in the second half of 2022.

Ranibizumab Biosimilars Report Insights
• Ranibizumab Biosimilars Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Ranibizumab Biosimilars Report Assessment
• Marketed product profiles
• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions
Current Treatment Scenario and Emerging Therapies:
• How many companies are developing Ranibizumab Biosimilars drugs?
• How many Ranibizumab Biosimilars drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Ranibizumab Biosimilars?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Ranibizumab Biosimilars therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Ranibizumab Biosimilars and their status?
• What are the key designations that have been granted to the emerging drugs?

Companies

• Intas Pharmaceuticals
• Reliance Life Sciences
• Senju Pharmaceutical
• Lupin
• Samsung Bioepis
• Xbrane
• Formycon/Bioeq/Coherus BioSciences
• Chong Kun Dang Pharmaceutical
• BIOCND/Qilu Pharmaceuticals
• GENERIUM Pharmaceuticals
• Shanghai Biomabs Pharmaceutical
• Celon pharma
• Biocure Technology
• Clonz Biotech
• PlantForm Corporation
• Siam Bioscience
• Polus
• Enzene Biosciences
• Paras Biopharmaceuticals