Intas Pharmaceuticals Ltd.

The FDA has accepted Bio-Thera Solutions' Biologics License Application for BAT2506, a proposed biosimilar to Simponi (golimumab), with a target review completion date of May 16, 2026.

India's drug regulatory authority has approved Eli Lilly's selpercatinib tablets in multiple strengths for RET fusion-positive non-small cell lung cancer treatment.

Sakar Healthcare received its second Marketing Authorization from the European Union for an oncology injection product targeting colorectal cancer treatment.

Coherus BioSciences has completed the divestiture of its UDENYCA pegfilgrastim franchise to Intas Pharmaceuticals in a deal valued at up to $558.4 million, receiving $483.4 million upfront with potential for $75 million in milestone payments.

Shanghai Henlius Biotech's serplulimab (Hetronifly) receives European Commission approval as the first anti-PD-1 antibody for extensive-stage small cell lung cancer treatment.

A new report provides an overview of the global clinical trial landscape for cerebral palsy, including trial numbers and enrollment trends.

• The European Commission has granted marketing authorization for Imuldosa, a biosimilar to Stelara (ustekinumab), for immune-mediated inflammatory diseases. • Imuldosa's approval is based on comprehensive data, including a Phase III trial demonstrating therapeutic equivalence and comparable safety to Stelara in plaque psoriasis patients. • Accord Healthcare plans to launch Imuldosa in the EU, targeting the ustekinumab market valued at approximately €2.9 billion (US$3.18 billion). • Imuldosa, developed in collaboration with Dong-A ST and Meiji Seika Pharma, has also received FDA approval and will be commercialized globally by Intas Pharmaceuticals.

• Intas Pharmaceuticals gains CDSCO approval for a Phase III trial comparing its aflibercept biosimilar with Eylea in diabetic macular edema (DME) patients. • The study will evaluate the efficacy, safety, and immunogenicity of Intas' aflibercept intravitreal injection against Eylea. • CDSCO's approval is contingent upon refined inclusion criteria, a minimum of 100 evaluable subjects in the test arm, and specific patient management protocols. • The trial protocol must include provisions for standard of care treatment for the fellow eye and discontinuation criteria based on adverse events.

The global biosimilars market is projected to grow from $36.01 billion in 2024 to $114.02 billion by 2031, representing a robust CAGR of 17.9%, fueled by increasing demand for cost-effective biologics.

• Intas Pharmaceuticals has been granted permission by the CDSCO's Subject Expert Committee to proceed with a Phase III clinical trial for its R-hFSH solution for injection. • The trial will assess the safety, efficacy, and immunogenicity of Intas' R-hFSH compared to Merck Serono's Gonal-F in adult females undergoing assisted reproductive technology. • The CDSCO panel recommended including more tertiary care centers and government sites in the Phase III clinical trial to ensure a diverse study population. • R-hFSH, a recombinant human follicle-stimulating hormone, is crucial for ovarian follicular growth in women and spermatogenesis in men with specific hormonal deficiencies.