BIOSIMILARS MARKET ANALYSIS

Biosimilars Market, By Drug Class (Recombinant Human Growth Hormone, Granulocyte Colony-Stimulating Factor, Insulin, Anticoagulants, Fusion Proteins Erythropoietin, Monoclonal Antibodies, Follitropin, Others), By Therapy Type (Oncology, Immunology, Hematology, Hormone Therapy, Metabolic Disorders, Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Specialty Pharmacies), By Geography (North America, Latin America, Europe, Asia Pacific, Middle East & Africa)

On July 2024, Amneal Pharmaceuticals, Inc. Pharmaceutical company has announced the inclusion of omalizumab, a biosimilar referencing XOLAIR, in its pipeline. Developed by Kashiv BioSciences, LLC, this humanized monoclonal antibody targets free immunoglobulin E (IgE) and is currently undergoing Phase III clinical trials initiated in Q3 2023.
In May 2024, Biocon Biologics Ltd (BBL), a global biosimilars company and subsidiary of Biocon Ltd, has received FDA approval for Yesafili (aflibercept-jbvf), an interchangeable* biosimilar of EYLEA (aflibercept). Yesafili is a vascular endothelial growth factor (VEGF) inhibitor used to treat various ophthalmic conditions.
In May 2022, Amneal Pharmaceuticals, Inc. received FDA approval for a Biologics License Application (BLA) for pegfilgrastim-pbbk, a biosimilar of Neulasta, which will be marketed as FYLNETRA. This approval marks a significant milestone in the biosimilar landscape.
In September 2021, Samsung Bioepis and Biogen announced FDA approval of BYOOVIZ (ranibizumab-nuna), a biosimilar to LUCENTIS (ranibizumab), for treating neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. BYOOVIZ is notable as the first biosimilar in ophthalmology approved in the United States.