Bio-Thera Solutions, Ltd.

FDA Approves Biocon Biologics' Bevacizumab Biosimilar JOBEVNE for Multiple Cancer Indications

2 months ago

• Biocon Biologics has received U.S. FDA approval for JOBEVNE (bevacizumab-nwgd), a biosimilar to Avastin, expanding its oncology portfolio to include a seventh FDA-approved biosimilar. • JOBEVNE, a VEGF inhibitor that restricts tumor blood supply, is indicated for multiple cancer types including metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, and several others. • The approval follows comprehensive comparative studies confirming JOBEVNE's similarity to Avastin, with U.S. bevacizumab sales reaching approximately $2 billion in 2023, representing a significant market opportunity.

EMA Accepts Bio-Thera's Marketing Application for BAT2506, First Chinese-Developed Golimumab Biosimilar

4 months ago

• Bio-Thera Solutions achieves milestone as the European Medicines Agency accepts marketing application for BAT2506, marking the first golimumab biosimilar from a Chinese company submitted for EU approval. • The biosimilar application is supported by comprehensive analytical data and clinical studies, including a Phase 3 trial in psoriatic arthritis patients demonstrating equivalence to Simponi®. • Through partnership with STADA Arzneimittel AG, BAT2506 aims to provide a more affordable treatment option for multiple inflammatory conditions including rheumatoid arthritis and ulcerative colitis.

Bio-Thera's BAT4406F Shows Promise in Neuromyelitis Optica Spectrum Disorders

4 months ago

• Bio-Thera Solutions announced Phase I clinical trial results for BAT4406F, an ADCC-enhanced anti-CD20 monoclonal antibody, in NMOSD patients. • The study demonstrated that BAT4406F was well-tolerated with a favorable safety profile in Chinese patients with neuromyelitis optica spectrum disorders. • BAT4406F led to rapid and significant B-cell depletion, with 86.7% of subjects remaining relapse-free during the six-month observation period. • A Phase II/III multicenter, randomized, double-blind, placebo-controlled trial of BAT4406F in Chinese NMOSD patients is currently underway.

FDA Approves Steqeyma and Yesintek: Expanding Biosimilar Options for Stelara

6 months ago

• The FDA has approved Steqeyma (ustekinumab-stba) and Yesintek (ustekinumab-kfce) as biosimilars to Stelara, offering new options for patients with autoimmune and inflammatory conditions. • Steqeyma and Yesintek are approved for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, mirroring Stelara's indications. • These approvals are expected to increase market competition and reduce treatment costs, with launches anticipated in early 2025 following licensing agreements.

FDA Approves Otulfi, a Stelara Biosimilar, for Inflammatory Conditions

8 months ago

• The FDA has approved Otulfi (ustekinumab-aauz) as a biosimilar to Stelara, offering a new treatment option for Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. • Otulfi, developed by Formycon and Fresenius Kabi, demonstrated comparable efficacy, safety, and immunogenicity to Stelara in clinical trials. • Fresenius Kabi plans to launch Otulfi in the U.S. by February 2025, following a settlement agreement with Johnson & Johnson, potentially increasing access to treatment. • The approval expands Fresenius Kabi's biosimilar portfolio and aligns with their strategy to become a significant player in the biopharmaceutical field globally.

Fresenius Kabi Launches First Actemra® Biosimilar in U.S. Market as Biosimilar Landscape Expands

a year ago

• Fresenius Kabi has launched Tyenne® (tocilizumab-aazg), the first biosimilar of Actemra® to enter the U.S. market, following FDA approval in March 2024 for both intravenous and subcutaneous formulations. • Accord BioPharma received FDA approval for Hercessi™ (trastuzumab-strf), becoming the sixth Herceptin® biosimilar approved in the U.S., while Xbrane's Xlucane™ (ranibizumab) received a Complete Response Letter from the FDA. • The expanding biosimilar market continues to challenge reference products with significant annual sales, with Actemra® generating approximately $3 billion, Herceptin® $1.77 billion, and Lucentis® $1.475 billion in 2023.