Shots:
The US FDA has approved Roche’s Lunsumio VELO (mosunetuzumab) as an SC formulation for the treatment of adults with r/r follicular lymphoma (FL) after ≥2L of systemic therapy, under accelerated approval
Approval was based on the P-I/II (GO29781) study in third-line or later FL pts, where Lunsumio VELO demonstrated an ORR of 75% and…
NEWS
Shots:
Samsung Bioepis has received Japanese marketing approval for Ustekinumab BS 45mg syringes, a biosimilar of Stelara, under its partnership with NIPRO Corporation
Ustekinumab, a human IgG1κ antibody targeting IL-12/IL-23, is approved in Japan as ‘NIPRO’ for plaque psoriasis and psoriatic arthritis, with NHI listing expected in May 2026
It is also approved in Australia, Brazil, Canada,…
Shots:
Biocon Biologics secured full global rights to Hulio (Adalimumab), a biosimilar of adalimumab, from Fujifilm Kyowa Kirin Biologics
As per the agreement, Biocon Biologics will take full responsibility for manufacturing, commercialization, and further development, while FKB will support development, offset certain development costs, and receive technology license fees and royalties for a specified tenure
Biocon Biologics…
Shots:
The US FDA has approved Nufymco (ranibizumab-leyk), an interchangeable biosimilar of Lucentis, with Zydus serving as its commercialization partner in the US
Nufymco is an interchangeable Lucentis biosimilar developed by Formycon, approved for the treatment of wet AMD, diabetic macular edema, diabetic retinopathy, retinal vein occlusion-related macular edema, and myopic choroidal neovascularization
Zydus secured exclusive US and Canada rights to Formycon’s Keytruda…
Shots:
The NMPA has approved Merck KGaA's Pimicotinib (PO) for the treatment of adults with symptomatic TGCT, where surgical resection can lead to functional limitation or relatively severe morbidity
Approval was based on the global 3-part P-III (MANEUVER) trial in TGCT pts who require systemic therapy & have not received prior anti-CSF-1/CSF-1R therapy, in which…
Shots:
Alvotech has reported the launch of Gobivaz (AVT05), a biosimilar version of Simponi (golimumab) for the treatment of several chronic inflammatory diseases, with commercialization led by Advanz Pharma
In the UK, Gobivaz’s launch is supported by an NHS England tender award, while rollout across EEA markets will advance in line with country-specific pricing, reimbursement…
Shots:
Daiichi Sankyo has dosed the first patient with Enhertu ± radiotherapy in the P-III (DESTINY-Endometrial02) trial, conducted in collaboration with The GOG Foundation & ENGOT, with the GINECO as the lead ENGOT group
The trial will evaluate the efficacy and safety of Enhertu (5.4mg/kg) ± radiotherapy vs SoC CT (carboplatin & paclitaxel) ± radiotherapy…
Shots:
Samsung Biologics’ US subsidiary entered a definitive agreement to acquire 100% of Human Genome Sciences from GSK, securing its first US based manufacturing site in Rockville, Maryland
As per the deal terms, Samsung Biologics will acquire the Rockville assets for $280M, with closing expected by end of Q1’26, while retaining 500+ employees to ensure…
Shots:
Jacobio Pharma entered a global exclusive licensing agreement with AstraZeneca for JAB-23E73, granting AstraZeneca exclusive development & commercialization rights outside China, while both companies will jointly develop & commercialize in China
As per the deal, Jacobio will receive $100M upfront, and is eligible up to $1.91B in development & commercial milestones, and tiered royalties…
Shots:
The EC has approved Tremfya (SC) for children (≥6yrs.) with mod. to sev. PsO, who are candidates for systemic therapy
Approval was based on P-III (PROTOSTAR) trial in 120 pediatric pts, which met its co-1EPs of PASI 75 (~76% vs 20%) & IGA 0/1 (66% vs 16%) at 16wks., with ~40% vs 4% achieving IGA…

