Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

Shots: The US FDA has approved & granted interchangeability designation to Omlyclo, a biosimilar to Xolair (omalizumab) for the treatment of mod. to sev. persistent asthma, CRSwNP, IgE-mediated food allergy, & chronic spontaneous urticaria (CSU) Approval was based on multiple clinical evidence, incl. P-III trial assessing Omlyclo (150mg, Q4W) vs Xolair (300mg, Q4W) in…

ByDipanshu DixitMarch 10, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (March 03, 2025 – March 07, 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: GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025 Read More: GSK Daiichi Sankyo Reports Interim Data of P-III (DESTINY-Gastric04) Study…

BySenior EditorMarch 7, 2025

NEWS

Biocon Biologics Report the P-III Study Positive Results of Yesintek (Biosimilar, Stelara)

Shots: Biocon Biologics revealed positive results from the P-III study demonstrating that Yesintek achieved equivalent efficacy, safety, immunogenicity, and PK vs reference product to treat mod. to sev. chronic plaque psoriasis (PsO) pts. (n=384, age= 18-80yrs.); data was presented at AAD 2025 The primary efficacy endpoint, percentage change in PASI scores at Wk. 12 showed…

ByDipanshu DixitMarch 7, 2025

NEWS

Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved Stoboclo & Osenvelt (CT-P41, denosumab), a biosimilar to Prolia & Xgeva for all indications of the reference products Approval is based on P-III trial results in postmenopausal women with osteoporosis, which showed equivalent efficacy & PD of CT-P41 to reference denosumab, with similar PK and comparable safety, and…

ByRidhi RastogiMarch 5, 2025

NEWS

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

Shots: Fresenius Kabi has launched Otulfi (ustekinumab- aauz) injection, a biosimilar to Stelara, developed by Formycon AG to treat mod. to sev. Crohn’s disease, ulcerative colitis, and plaque psoriasis & active psoriatic arthritis (age ≥ 6 yrs.) across the US Otulfi will be available in the US in 45 mg/0.5 mL and 90 mg/mL prefilled…

ByDipanshu DixitMarch 3, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 24, 2025 – February 28, 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: Estrella Immunopharma Reports the Approval to Start a Higher Dose Cohort After the Completion of First Dose Cohort in STARLIGHT-1 Study Read More: Estrella Immunopharma Regeneron Presents P-I/II (CHORD) Trial Data…

BySenior EditorFebruary 28, 2025

NEWS

Biocon Biologics Launches Yesintek (Biosimilar, Stelara) in the US

Shots: Biocon Biologics has launched Yesintek (ustekinumab- kfce), 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 available presentations are 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial The approval was…

ByRidhi RastogiFebruary 24, 2025

NEWS

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

Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

PharmaShots Weekly Snapshots (March 03, 2025 – March 07, 2025)

Biocon Biologics Report the P-III Study Positive Results of Yesintek (Biosimilar, Stelara)

Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

PharmaShots Weekly Snapshots (February 24, 2025 – February 28, 2025)

Biocon Biologics Launches Yesintek (Biosimilar, Stelara) in the US

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

Contact US

FOLLOW US