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Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients
Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the…
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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…
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Characterized by an itchy skin rash, urticaria, commonly known as hives, is often triggered by allergic reactions to food, medications, or contact with irritants.
PharmaShots’ Disease of the Month report aims to educate a broad audience about health conditions affecting communities across the globe. This monthly feature provides a comprehensive overview of each disease,…
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The EC has approved Attrogy (diflunisal) to treat hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults with stage 1 or 2 polyneuropathy in all EEA states
EC approval was based on a P-III trial showing that diflunisal significantly slowed disease progression in patients with TTR amyloidosis. At 24 mos. baseline, 1EP met diflunisal led to…
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The CHMP has recommended to Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery but do not currently require radiotherapy or CT; anticipated EC decision in all 30 EEA states
The CHMP opinion is based on the global P-III (INDIGO) trial (N=331), which included…
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Health Canada has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy
Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade + PomDex in 302 pts, respectively
DREAMM-7 showed improved PFS (1EP; mPFS: 36.6 vs 13.4mos.),…
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The EMA’s CHMP has granted positive opinions and approvals to 2 Biologics and 6 new chemical entities in June 2025, leading to treatments for patients and advances in the healthcare industry
The major highlighted drug was SpringWorks Therapeutics’ Ogsiveo to Treat Desmoid Tumours
PharmaShots has compiled a list of 8 drugs that have been…
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The EC has approved Aucatzyl (Obecabtagene Autoleucel) for treating pts (≥26yrs.) with r/r B-ALL in all 30 EEA states
The EC approval was based on the FELIX study (n=100+), which showed that pts in cohort IIA (n=94) receiving ≥1 infusion of obe-cel had a 76.6% CR/CRi rate, with a mDoR of 21.2mos. & mEFS…

