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Samsung Bioepis
NEWS

Samsung Bioepis Reports the US FDA’s approval of Ospomyv & Xbryk (Biosimilar, Prolia & Xgeva)

Shots: The EC has approved SB16: Ospomyv (denosumab-dssb; 60mg pre-filled syringe) & Xbryk (denosumab-dssb; 120mg vial), a biosimilar version of Prolia & Xgeva for osteoporosis & prevention of skeletal related events, respectively Approval was based on the P-I trial which confirmed PK equivalence between SB16, EU-DEN & US-DEN among healthy males, in terms of AUC from…
February 16, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 10th, 2025 – February 14th, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health & Biosimilars. Check out our full report below:      Eli Lilly Reveals VIVID-2 Study Data of Omvoh to Treat Crohn's Disease  Read More: Eli Lilly  Regeneron Reveals Data from Extended P-III (PULSAR) Trial of Eylea HD for Wet Age-related Macular Degeneration  Read…
February 14, 2025

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Celltrion
NEWS

Celltrion Secures the US FDA’s Approval for Avtozma IV/SC (Biosimilar, Actemra)

Shots: The US FDA has approved Avtozma IV/SC (biosimilar, Actemra) to treat rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and COVID-19; expected to be commercially available by August 2025 in US Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs Actemra (tocilizumab) in…
February 12, 2025

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Teva & Samsung Bioepis
NEWS

Samsung Bioepis and Teva Partners to Commercialize Epysqli (Biosimilar, Soliris) in the US

Shots: Samsung Bioepis and Teva have signed a development and commercialization license agreement for Epysqli (eculizumab-aagh), a biosimilar to Soliris (eculizumab), in the US Under the agreement, Samsung Bioepis will manage development, regulatory registration, manufacturing, and supply, while Teva will oversee commercialization in the US. The financial terms are confidential. This deal increases Teva's biosimilar…
February 10, 2025

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Bio-Thera & Intas
NEWS

Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across the US

Shots: Bio-Thera and Intas Pharmaceuticals have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) in the US As per the agreement, Bio-Thera is entitled to receive $21M upfront and an additional $143.5M in development and commercial milestones BAT2506 is an IgG1 monoclonal antibody targeting TNF-alpha,…
February 10, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 3, 2025 – February 7, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health & DigiHealth. Check out our full report below:      Algiax Pharmaceuticals Reports Topline Data from P-IIa Trial of AP-325 for Neuropathic Pain  Read More: Algiax Pharmaceuticals  Pfizer Reveals Data from the P-III (BREAKWATER) trial of Braftovi Regimen in Patients with Metastatic…
February 7, 2025

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Lotus Pharma & Formycon
NEWS

Lotus Pharmaceutical and Formycon Enter into a Strategic Partnership to Commercialize FYB203/Ahzantive (Biosimilar, Eylea) in APAC

Shots: Formycon has signed an exclusive license agreement with Lotus Pharmaceutical to commercialize FYB203/Ahzantive in APAC countries, including Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam, and Hong Kong. Additionally, Formycon will supply the finished product to Lotus As per the agreement, Klinge will receive upfront and milestone payments, along with royalties on Lotus’ net…
February 5, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (January 27, 2025 – January 31, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & DigiHealth. Check out our full report below:      Merck and Eisai Reveal Latest Data from P-III (LEAP-015) Trial of Keytruda (pembrolizumab) and Lenvima (lenvatinib) Regimen to Treat Gastroesophageal Adenocarcinoma  Read More: Merck and Eisai  Novo Nordisk Completes P-Ib/IIa Study…
January 31, 2025

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