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

Shots: The US FDA has approved Avtozma (biosimilar, Actemra) for treating diseases such as RA, GCA, pJIA, sJIA, and COVID-19 Approval was based on P-III trial of Avtozma (tocilizumab-anoh) vs Actemra (tocilizumab) in mod. to sev. RA pts demonstrated biosimilarity, change in disease activity score using 28 joints (DAS28)-ESR (1EP) at wk.24 & with…

ByDipanshu DixitJanuary 31, 2025

News

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Shots: The US FDA has accepted BLA for AVT05, a biosimilar version of Simponi & Simponi Aria (golimumab), with completion of the review process anticipated in Q4’25 Alvotech reported topline results from a confirmatory trial evaluating the efficacy, safety, & immunogenicity of AVT05 vs Simponi in mod. to sev. rheumatoid arthritis patients in Apr…

ByRidhi RastogiJanuary 28, 2025

Weekly Snapshot

PharmaShots Weekly Snapshots (January 20, 2025 – January 24, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, DigiHealth, MedTech, Biosimilars, Animal Health & Biotech. Check out our full report below: Novo Nordisk Reports Headline Results from P-IIIb (STEP UP) Study of Semaglutide 7.2mg in Obese Adults without Diabetes Read More: Novo Nordisk Yoltech Initiates a Dose-Escalation Study for YOLT-204 to Treat…

BySenior EditorJanuary 24, 2025

News

Formycon Reports the EC’s Approval of FYB203 (Biosimilar, Eylea) Under the Brand Names Ahzantive and Baiama

Shots: Formycon & Klinge Biopharma have reported the EC’s approval of FYB203, biosimilar of Eylea (aflibercept), under the brand names: Ahzantive & Baiama valid across the EU plus Iceland, Liechtenstein & Norway after receiving the CHMP’s recommendation in Nov 2024 The biosimilar is intended to treat Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other…

BySenior EditorJanuary 21, 2025

Weekly Snapshot

PharmaShots Weekly Snapshots (January 13, 2025 – January 17, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & Biotech. Check out our full report below: Bayer Reports Topline Data from P-III (QUANTI) Trials of Gadoquatrane for its Use in MRI Read More: Bayer Oryzon Reports Dosing of the First Patient with Iadademstat + Venetoclax + Azacitidine…

BySenior EditorJanuary 17, 2025

News

Biothera and World Medicine Partners to Commercialize BAT2206 (Biosimilar: Ustekinumab) in Turkey

Shots: Bio-Thera & World Medicine entered into an exclusive license & commercialization agreement for BAT2206, a biosimilar to Janssen’s Stelara (ustekinumab), leveraging World Medicine’s marketing expertise & distribution network in Turkey As per the terms, World Medicine will hold market approval of BAT2206 in Turkey as well as its registration, imports, promotion & marketing, while…

BySenior EditorJanuary 17, 2025

News

Formycon and Fresenius Kabi Report the MHRA’s Approval of Otulfi (Biosimilar, Stelara)

Shots: The UK’s MHRA has approved Otulfi (SC & IV), biosimilar of J&J’s Stelara (ustekinumab), to treat mod. to sev. active Crohn's disease, ulcerative colitis, plaque psoriasis as well as active psoriatic arthritis & is set to enter UK market as per a confidential settlement b/w the companies and J&J. It is approved across the US,…

BySenior EditorJanuary 16, 2025

News

Teva Partners with Klinge Biopharma & Formycon to Commercialize FYB203 (Biosimilar: Aflibercept) in EU & Israel

Shots: Teva Pharmaceuticals International secured semi-exclusive marketing rights for FYB203, a biosimilar of Eylea (aflibercept), in Europe (excl. Italy) & Israel via a deal with Klinge & Formycon, boosting Teva’s biosimilar portfolio The deal combines Teva’s commercial expertise & distribution network with Formycon’s biosimilar development capabilities, following their successful collaboration on marketing FYB201, a…

ByDipanshu DixitJanuary 14, 2025

Weekly Snapshot

PharmaShots Weekly Snapshots (January 06, 2025 – January 10, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & Biotech. Check out our full report below: Oculis Reports Results from P-II (ACUITY) Study of OCS-05 for Treating Acute Optic Neuritis Read More: Oculis PharmaEssentia Reports Topline Data from P-III (SURPASS-ET) Trial of Ropeginterferon Alfa-2b-Njft (P1101) in Essential…

BySenior EditorJanuary 10, 2025

News

Fresenius Kabi Canada Receives Health Canada NOC for Otulfi (Biosimilar, Stelara)

Shots: Following the NOC approval of Tyenne (tocilizumab) & Idacio (adalimumab), Fresenius Kabi Canada has received Health Canada NOC for Otulfi (ustekinumab), a biosimilar to Stelara for Crohn's disease, ulcerative colitis, plaque psoriasis, and active psoriatic arthritis NOC approval was granted after the analysis of analytical, preclinical, clinical & manufacturing results that showed equivalent…

ByDipanshu DixitJanuary 8, 2025

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

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

PharmaShots Weekly Snapshots (January 20, 2025 – January 24, 2025)

Formycon Reports the EC’s Approval of FYB203 (Biosimilar, Eylea) Under the Brand Names Ahzantive and Baiama

PharmaShots Weekly Snapshots (January 13, 2025 – January 17, 2025)

Biothera and World Medicine Partners to Commercialize BAT2206 (Biosimilar: Ustekinumab) in Turkey

Formycon and Fresenius Kabi Report the MHRA’s Approval of Otulfi (Biosimilar, Stelara)

Teva Partners with Klinge Biopharma & Formycon to Commercialize FYB203 (Biosimilar: Aflibercept) in EU & Israel

PharmaShots Weekly Snapshots (January 06, 2025 – January 10, 2025)

Fresenius Kabi Canada Receives Health Canada NOC for Otulfi (Biosimilar, Stelara)

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