Intas Pharmaceuticals Ltd.

The FDA has approved CAMCEVI ETM (leuprolide mesylate 21 mg), a ready-to-use long-acting injectable formulation administered every 3 months for advanced prostate cancer treatment.

Accord BioPharma has commercially launched IMULDOSA (ustekinumab-srlf), a biosimilar to STELARA, with prefilled syringes priced at the lowest wholesaler acquisition cost among branded ustekinumab biosimilars at a 92% discount.

Intas Pharmaceuticals and Accord BioPharma have completed the acquisition of UDENYCA (pegfilgrastim-cbqv), a biosimilar to Amgen's Neulasta, from Coherus BioSciences.

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.