Latest Biosimilars News

Amgen delivered 8% third-quarter revenue growth and a 19% increase in GAAP diluted EPS, while newer medicines continued to expand. The result came alongside sharp declines in Prolia and XGEVA sales from biosimilar competition and a busy pipeline of late-stage programmes.

IDT Australia reports a sharp turnaround in FY26 with a 66% reduction in net loss and an 85% improvement in EBITDA, underpinned by a strategic reset and targeted investments in manufacturing capabilities.

Avecho Biotechnology reported a 9.3% revenue increase alongside a 41.5% rise in net loss for 2025, while progressing its Phase III CBD insomnia trial and securing a significant licensing agreement with Sandoz.

Algorae Pharmaceuticals has secured a key distribution agreement with global giant Dr. Reddy’s Laboratories to supply the chemotherapy drug Capecitabine in Australia, marking a significant step in its oncology commercialisation strategy.

Mesoblast Limited marked a transformative year with FDA approval and commercial launch of Ryoncil, its first mesenchymal stromal cell therapy, driving a 191% jump in cell therapy revenues. The company is now poised to expand its footprint in inflammatory diseases with multiple clinical trials and label extensions underway.

Mesoblast has reported a strong commercial debut for Ryoncil, the first FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft-versus-host disease, generating US$13.2 million in gross revenue in its initial quarter. The company is advancing regulatory and clinical milestones while expanding insurance coverage across the US.

Cyclopharm Limited has secured the maximum five-year U.S. patent extension for its flagship Technegas® Kit, extending market exclusivity to 2031 and reinforcing its strategic foothold in pulmonary imaging.

Avecho Biotechnology has expanded its pivotal Phase III clinical trial for a CBD insomnia treatment by adding new recruitment sites and partnering with pharmaceutical giant Sandoz to boost patient enrolment and regulatory progress.

Cynata Therapeutics confirms that the recent FDA orphan-drug exclusivity granted to Ryoncil® will not block approval of its CYP-001 therapy, highlighting key differences in drug composition and patient indications.

Mesoblast has been granted a seven-year orphan-drug exclusivity by the FDA for its cell therapy Ryoncil, reinforcing its market position in treating steroid-refractory acute graft versus host disease in children.

Clarity Pharmaceuticals has expanded its breast cancer pipeline by introducing 64/67Cu-SAR-trastuzumab, supported by promising pre-clinical data and a new supply agreement for trastuzumab, aiming to address the unmet needs in HER2-positive breast cancer treatment.