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Lupin has entered into a licensing agreement with Sandoz to market & commercialize Lupin’s ranibizumab biosimilar in multiple regions
As per the deal, Sandoz will commercialize the product in the EU (excl. Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, & Malaysia, while holding exclusive rights in most markets & semi-exclusive rights in France, Australia,…
This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, Biotech, M&A and Biosimilars. Check out our full report below:
Roche Reports P-III (Portal) Trial Data on Susvimo for Neovascular Age-Related Macular Degeneration (nAMD)
Read More: Roche
Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma
Read…
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The US FDA has approved Avtozma IV, a biosimilar to Actemra (tocilizumab), for treating cytokine release syndrome in pts (≥2yrs.), covering all Actemra IV-approved indications in the US; expected to be available in the US by Aug 31, 2025
In Jan 2025, the US FDA approved Avtozma IV to treat rheumatoid arthritis (RA), giant…
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Intas Pharmaceuticals, through its Accord subsidiaries, has completed the acquisition of Coherus BioSciences’ Udenyca (pegfilgrastim-cbqv), a biosimilar of Neulasta
With the acquisition, Accord BioPharma, Intas’ U.S. specialty arm, continues Udenyca commercialization, offering patient-friendly administration options autoinjector (AI), on-body injector (OBI), and prefilled syringe (PFS)
Udenyca is a leukocyte growth factor used to reduce infection risk in…
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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…
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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…
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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…
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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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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…

