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

Shots: The US FDA has approved Otulfi (SC & IV), biosimilar of Stelara (ustekinumab), to treat Crohn’s disease, ulcerative colitis, mod. to sev. plaque PsO & active psoriatic arthritis. Fresenius Kabi can market Otulfi by Feb 22, 2025 Approval was based on analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity…

ByDipanshu DixitSeptember 30, 2024

NEWS

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases

Shots: The EC has approved Otulfi (IV/SC), a biosimilar of Stelara (ustekinumab), to treat mod. to sev. active CD, mod. to sev. plaque PsO & active PsA, valid across EU as well as Iceland, Liechtenstein & Norway Approval was based on analytical, pre-clinical, clinical & manufacturing data, depicting similar effectiveness, safety & PK profile of…

ByDipanshu DixitSeptember 27, 2024

NEWS

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases

Shots: The EC has approved Otulfi (IV/SC), a biosimilar of Stelara (ustekinumab), to treat mod. to sev. active CD, mod. to sev. plaque PsO & active PsA, valid across EU as well as Iceland, Liechtenstein & Norway Approval was based on analytical, pre-clinical, clinical & manufacturing data, depicting similar effectiveness, safety & PK profile of…

ByDipanshu DixitSeptember 27, 2024

NEWS

Bio-Thera Solutions Expands its Partnership with Pharmapark for BAT2306 (Biosimilar, Cosentyx) Across Russia and Other Countries

Shots: Pharmapark will hold exclusive distribution, and marketing rights & filing for BAT2306 (Secukinumab bsm) which has finished the P-I & P-III study globally and plans to submit applications for approval to the NMPA, EMA & FDA. Under the terms of the agreement, BAT2306 will be developed & supplied by Bio-Thera at its Guangzhou, China…

ByDipanshu DixitAugust 16, 2024

NEWS

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Shots: The US FDA has approved Pyzchiva, a biosimilar of Stelara (ustekinumab), for treating moderate to severe plaque PsO patients eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active UC Approval was based on studies of Pyzchiva vs Stelara incl. P-I, showing similarity in PK, safety, tolerability…

ByDipanshu DixitJune 28, 2024

NEWS

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Shots: The US FDA has approved Pyzchiva, a biosimilar of Stelara (ustekinumab), for treating moderate to severe plaque PsO patients eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active UC Approval was based on studies of Pyzchiva vs Stelara incl. P-I, showing similarity in PK, safety, tolerability…

ByDipanshu DixitJune 28, 2024

VIEWPOINTS

Treating Plaque Psoriasis with VTAMA: Dermavant ‘s Philip M. Brown & G. Michael Lewitt in Conversation with PharmaShots

Shots: G. Michael Lewitt and Philip M.Brown enlightened PharmaShots’ audience on Dermavant Sciences’ VTAMA cream a first-in-its-class topical prescription medication approved for Plaque Psoriasis Michael & Philip discussed VTAMA’s study design along with its MOA, ROA, and formulation while shedding light on P-IV data Philip further goes ahead to share details on VTAMA’s ongoing study…

BySaurabh ChaubeyFebruary 29, 2024

NEWS

Rani Therapeutics Reports the Results for RT-111 Capsules Containing CT-P43 (biosimilar, ustekinumab) in P-I Trial for the Treatment of Various Indications

Shots: The P-I clinical trial evaluates the safety & efficacy of RT-111 in delivering CT-P43 (biosimilar, ustekinumab) in patients with moderate to severe plaque psoriasis, active psoriatic arthritis & IBD As per the results, RT-111 delivered CT-P43 in a dose proportional manner with high bioavailability & depicted a higher Cmax & shorter Tmax vs ustekinumab…

ByDipanshu DixitFebruary 3, 2024

INSIGHTS+

Insights+ Key Biosimilars Events of December 2023

Shots: Stay up to date with PharmaShots Biosimilars Report, a monthly digest designed to keep you familiarized with the recent developments in biologics Biosimilars are cost-effective alternatives to branded drugs but are very much alike when it comes to safety and efficacy Check out the developments in the Biosimilars with PharmaShots’ illuminating report. PharmaShots has…

BySenior EditorJanuary 9, 2024

NEWS

Accord BioPharma Reports US FDA’s Acceptance of BLA for DMB-3115 (Biosimilar, Stelara)

Shots :The US FDA has accepted the BLA for DMB-3115 based on the results from P-III multi-regional studies for treating plaque psoriasis having rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms as its 1EP. The results showed similar quality, safety and efficacy between DMB-3115 vs Stelara Accord BioPharma…

ByDipanshu DixitJanuary 4, 2024

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

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases

Bio-Thera Solutions Expands its Partnership with Pharmapark for BAT2306 (Biosimilar, Cosentyx) Across Russia and Other Countries

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Treating Plaque Psoriasis with VTAMA: Dermavant ‘s Philip M. Brown & G. Michael Lewitt in Conversation with PharmaShots

Rani Therapeutics Reports the Results for RT-111 Capsules Containing CT-P43 (biosimilar, ustekinumab) in P-I Trial for the Treatment of Various Indications

Insights+ Key Biosimilars Events of December 2023

Accord BioPharma Reports US FDA’s Acceptance of BLA for DMB-3115 (Biosimilar, Stelara)

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