Skip to content Skip to footer
Subscribe Now
Formycon and Fresenius Kabi
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…
September 27, 2024

Read more

Formycon and Fresenius Kabi
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…
September 27, 2024

Read more

Bio-Thera New
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…
August 16, 2024

Read more

VIEWPOINTS_Philip M. Brown1_G. Michael Lewitt2_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…
February 29, 2024

Read more

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…
February 3, 2024

Read more

Insights+ Key Biosimilars Events of December 2023
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…
January 9, 2024

Read more

Insights+ Key Biosimilars Events of November 2023
INSIGHTS+

Insights+ Key Biosimilars Events of November 2023

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency   Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   During November, Amgen received US FDA approval for Wezlana, biosimilar of ustekinumab &…
December 6, 2023

Read more

Load more