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Fresenius Kabi

Fresenius Kabi Launches Tyenne (Biosimilar, Actemra) Across Canada 

Shots: Following the launch of Idacio (adalimumab) Citrate-free, Fresenius Kabi Canada has launched Tyenne (IV/SC), a biosimilar version of Actemra (tocilizumab) from Roche, now available in Canada Tyenne (IL-6 receptor blocker) is approved to treat inflammatory and immune conditions such as rheumatoid arthritis (RA), giant cell arteritis (GCA), Polyarticular juvenile idiopathic arthritis (pJIA), and systemic…

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Biogen & Organon

Organon Acquires Regulatory and Commercial Rights of Tofidence IV Infusion (Biosimilar, Actemra) from Biogen

Shots:Organon has acquired the US regulatory & commercial rights for Tofidence, a biosimilar version of Actemra (tocilizumab), from Biogen, which retains manufacturing rights in the USAs per the deal, Biogen will receive upfront, while Organon will assume Biogen's obligation to pay Bio-Thera tiered annual net sales royalties & milestonesTofidence is a humanized…

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Fresenius Kabi

Fresenius Kabi Reports the US FDA’s Approval for Tyenne (Biosimilar, tocilizumab-aazg) as a Treatment of Immunological and Oncological Indications 

Shots: The US FDA approved Fresenius’ Tyenne (tocilizumab-aazg) developed as a biosimilar version of Actemra (tocilizumab)  According to the patent settlement agreement signed between Fresenius Kabi and Genentech for Tyenne, Fresenius has the license to market its tocilizumab products across the US as per the undisclosed licensing dates  Tyenne functions as an Interleukin-6 (IL-6) receptor…

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Celltrion

Celltrion Reports the MAA Submission to the MFDS Korea for CT-P47 (biosimilar, tocilizumab) to Treat Various Indications  

Shots:  The submission was based on the results from the P-III clinical trials evaluating the equivalence & similarity of CT-P47 vs Actemra (tocilizumab) in patients (n=471) with rheumatoid arthritis (RA)  Moreover, based on these results the company also expects to accelerate its marketing authorization application across Canada & other countries. The company expects to receive…

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Insights+ Key Biosimilars Events of September 2023

Insights+ Key Biosimilars Events of September 2023

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars 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 patientsDuring the month of September, Sandoz entered into a development and commercialization agreement…

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VIEWPOINTS_Dr. Mourad Farouk Rezk_2023

Dr. Mourad Farouk Rezk, Head of Global Medical & Development Biogen Biosimilars Shares Insights on BLA Acceptance for BIIB800

Shots:Dr. Mourad spoke about the acceptance of aBLA for BIIB800, a Tocilizumab biosimilar candidate for several autoimmune diseases, including rheumatoid arthritisHe briefed about the study design and results from the P-III trial which supported the BLA filingThis interview focuses on Biogen's notable progress in addressing challenging immunologic conditions, offering potential solutions to…

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VIEWPOINTS_Dr. Mourad Farouk Rezk1_2023

Dr. Mourad Farouk Rezk, Head of Global Medical & Development Biogen Biosimilars Shares Insights on Positive P-III Data for BIIB800 (Actemra biosimilar)

Shots :Dr. Mourad talked about the positive P-III data showing results for BIIB800, a Tocilizumab biosimilar candidate presented at the Annual European Congress of Rheumatology (EULAR 2022)He also spoke about the results of the 48-week analysis of the PROPER trial evaluating   adalimumab biosimilar, Imraldi, in patients with autoimmune diseasesThe interview highlights Biogen's…

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Thoughtspot_Dr. Anish Desai

COVID-19 Treatment in India and Abroad

In late 2019, a mysterious virus causing infection consisting of dry cough, fever tiredness, and last pneumonia first appeared in Wuhan, China. The world health organization (WHO) named the disease as Coronavirus 2019 (Covid-19). Interestingly, Covid-19 and flu (caused by influenza virus) share the common disease progression asymptomatic (no symptoms), mild symptoms fever or chills,…

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