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Celltrion
NEWS

Celltrion Receives the Health Canada’s Approval for Stoboclo and Osenvelt (Biosimilar, Prolia & Xgeva)

Shots: Health Canada has approved Stoboclo & Osenvelt (CT-P41), referencing biosimilar Prolia & Xgeva, for all approved indications of the reference drugs Approval was supported by P-III trial data in postmenopausal women with osteoporosis (PMO), showing CT-P41 matched reference denosumab in efficacy & PD, with similar PK, safety, and immunogenicity Stoboclo and Osenvelt are RANKL…
September 19, 2025

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Incyte
NEWS

Incyte Reports the US FDA’s sNDA Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

Shots: The FDA has approved Opzelura cream 1.5% for short-term and non-continuous treatment of mild to moderate AD in non-immunocompromised children (aged≥ 2), when other topical therapies are ineffective or unsuitable sNDA approval was based on the P-III (TRuE-AD3) trial which evaluated the safety and efficacy of ruxolitinib in over 300 children receiving 0.75%, 1.5%,…
September 19, 2025

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NEWS

Formycon and Klinge Biopharma sign a semi-exclusive licensing deal with Horus Pharma to commercialize the FYB203/Baiama (Biosimilar, Eylea)  

Shots:  Formycon and Klinge Biopharma have signed a semi-exclusive licensing deal with Horus Pharma to commercialize the FYB203/Baiama (Biosimilar, Eylea) in selected EC, following a similar agreement with Teva in Jan for covering major parts of the EU & Israel  Klinge will receive upfront, milestone payments, and royalties on net sales, with Formycon earning a…
September 17, 2025

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INSIGHTS+

Key Biosimilars Events of August 2025  

Shots:        Biosimilars are developed to be highly similar 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         Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea). Our…
September 2, 2025

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INSIGHTS+

Disease of the Month – Rosacea 

Shots:  Rosacea is a chronic skin condition characterized by facial redness, acne-like breakouts, and flushing. It may cause enlarged blood vessels and small pus pus-filled bumps   PharmaShots’ Disease of the Month report aims to educate a broad audience about health conditions that affect communities worldwide. These reports provide a comprehensive overview of disease, including their…
August 27, 2025

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NEWS

BioArctic and Novartis sign agreement for BrainTransporter ~$802M

Shots: BioArctic has entered into an option, collaboration, and license agreement with Novartis to develop a neurodegeneration treatment using BrainTransporter As per the deal, BioArctic receives $30M upfront and could earn up to $772M in milestones plus tiered mid-single-digit royalties if Novartis licenses and commercializes the drug BioArctic will develop a drug candidate using BrainTransporter and a Novartis…
August 26, 2025

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