Shots:
Kashiv BioSciences and MS Pharma have signed a license & supply agreement for ADL-018, a Xolair (omalizumab) biosimilar, across the Middle East and North Africa (MENA) region, with anticipated regulatory submissions in Q4’25
Under the agreement, Kashiv BioSciences will develop ADL-018, while MS Pharma will handle licensing, distribution, and commercialization in MENA, with local…
Shots:
Polpharma has entered into a global licensing agreement with Fresenius Kabi to commercialize PB016, a biosimilar version of Takeda’s Entyvio (vedolizumab) for the treatment of mod. to sev. ulcerative colitis & Crohn’s disease
As per the deal, Fresenius will obtain global commercialization rights to PB016, excl. Middle East & North Africa, while Polpharma will…
Shots:
CivicaScript announced plans to distribute the biosimilar ustekinumab-aauz for CICs incl. plaque PsO, PsA, Crohn’s disease, and ulcerative colitis, with its launch anticipated on Jan 01, 2026
Ustekinumab-aauz targets IL-12 & 23, helping regulate immune and inflammatory responses. Produced by Fresenius Kabi, it will be exclusively distributed by CivicaScript in the US and is interchangeable with…
This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, Animal Health and Biosimilars. Check out our full report below:
Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients
Read More: Memo therapeutics
Eli Lilly Reports Topline P-III (BRUIN…
Shots:
The CHMP has recommended Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion & visual impairment due to diabetic macular oedema & myopic choroidal neovascularisation
Opinion was based on extensive analytical, non-clinical, & clinical data incl. a P-III trial…
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Shots:
The CHMP has recommended approval of HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab) for all indications of the reference product; review is ongoing in the US, Canada & other regions
Opinion was based on multiple H2H trials, incl. analytical & clinical studies, which showed similar quality, efficacy & safety of HLX14 vs…
This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health and Biosimilars. Check out our full report below:
AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC
Read More: AstraZeneca
Sun Pharma Reports Topline Data from P-III (INSPIRE-1 & INSPIRE-2) Trials of…
Shots:
The EC has approved Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab)
Approval covers all indications of the reference products incl. osteoporosis in postmenopausal women & men at high risk of fracture, SRE prevention in adults with bone-involved malignancies, giant cell tumors of bone & treatment-related bone loss
Additionally, Fresenius & Amgen…
This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, DigiHealth and Biosimilars. Check out our full report below:
Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1)
Read More: Takeda
AstraZeneca Reports P-III (BaxHTN) Trial Results of Baxdrostat for Uncontrolled or Treatment Resistant…
Shots:
Samsung Bioepis has entered into a definitive agreement to grant Harrow exclusive commercial rights of its ophthalmology biosimilar portfolio incl. Byooviz, biosimilar to Lucentis (ranibizumab), & Opuviz, biosimilar to Eylea (aflibercept) in the US
Byooviz has been available in the US through Biogen since its launch in Jun 2022. In Oct 2024, Biogen notified…

