Alvotech and Teva Launch Selarsdi (Biosimilar, Stelara) in the US

Shots: Alvotech and Teva have launched Selarsdi (ustekinumab-aekn) injection, a biosimilar to Stelara, to treat psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis across the US The FDA has provisionally determined that all Selarsdi presentations can be approved as interchangeable with Stelara after exclusivity expires on Apr…

ByRidhi RastogiFebruary 24, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 17th, 2025 – February 21th, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, COVID 19 & Biosimilars. Check out our full report below: AstraZeneca Presents Post-Hoc Data from P-III (NIAGARA) Trial of Imfinzi in Muscle-Invasive Bladder Cancer Patients regardless of Complete Pathology Response at ASCO GU 2025 Read More: AstraZeneca Exelixis Presents 5-year…

BySenior EditorFebruary 21, 2025

NEWS

Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US

Shots: The US FDA has accepted the BLA of AVT06 (2mg) for treating eye disorders, including diseases that can lead to vision loss or blindness. The regulatory approval process is expected to finish in Q4’25 AVT06/AVT29 is a recombinant fusion protein and biosimilar candidate to Eylea (aflibercept), targeting VEGF to inhibit receptor activation, neovascularization,…

ByRidhi RastogiFebruary 20, 2025

NEWS

Celltrion Secures the EC’s Approval for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Shots: The EC has approved Eydenzelt (CT-P42, aflibercept), a biosimilar to Eylea, Stoboclo & Osenvelt (CT-P41, denosumab), a biosimilar to Prolia & Xgeva for all indications of the reference products The P-III trial of Eydenzelt (40 mg/mL solution for injection in a vial & pre-filled syringe) vs Eylea (aflibercept) in diabetic macular edema (DME)…

ByRidhi RastogiFebruary 19, 2025

NEWS

Samsung Bioepis Reports the EC’s approval of Obodence & Xbryk (Biosimilar, Denosumab)

Shots: The EC has approved SB16: Obodence (60mg pre-filled syringe; Biosimilar: Prolia) & Xbryk (120mg vial; Biosimilar: 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 (n=168), in terms of AUC from time zero to…

ByRidhi RastogiFebruary 17, 2025

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…

ByRidhi RastogiFebruary 16, 2025

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…

BySenior EditorFebruary 14, 2025

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…

ByRidhi RastogiFebruary 12, 2025

NEWS

Dr. Reddy’s Partners with Henlius to Commercialize HLX15 (Biosimilar, Darzalex & Darzalex Faspro) in the US & EU

Shots: Dr. Reddy’s & Henlius have entered into a license agreement to develop & market HLX15, biosimilar version of Darzalex & Darzalex Faspro (daratumumab) As per the agreement, Dr. Reddy’s will get exclusive rights to market HLX15 (SC & IV) in the US & EU in exchange for ~$131.6M ($33M upfront + milestones), plus…

ByRidhi RastogiFebruary 10, 2025

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…

ByRidhi RastogiFebruary 10, 2025

Alvotech and Teva Launch Selarsdi (Biosimilar, Stelara) in the US

PharmaShots Weekly Snapshots (February 17th, 2025 – February 21th, 2025)

Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US

Celltrion Secures the EC’s Approval for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Samsung Bioepis Reports the EC’s approval of Obodence & Xbryk (Biosimilar, Denosumab)

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

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

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

Dr. Reddy’s Partners with Henlius to Commercialize HLX15 (Biosimilar, Darzalex & Darzalex Faspro) in the US & EU

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

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