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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…
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The company has introduced SC formulation of Tyenne, a biosimilar of Actemra, to treat chronic autoimmune diseases across the US. It is available in the form of prefilled syringe & an autoinjector
The IV formulation of the biosimilar was introduced in Apr 2024 after the US FDA’s approval on Mar 05, 2024
Tyenne, an…
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The company has launched Tyenne (biosimilar, Actemra) in the US, to treat chronic autoimmune diseases; got approved on Mar 05, 2024
Tyenne, an Interleukin-6 (IL-6) receptor antagonist developed by using Fresenius’ analytical & manufacturing technologies to treat several autoimmune diseases incl. rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis & systemic juvenile idiopathic…
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Celltrion has submitted BLA to the US FDA seeking approval for CT-P47 in both IV and SC route of administrations based on the P-III study
The P-III study assesses the safety, efficacy, PK, and immunogenicity of CT-P47 vs Actemra for treating moderate to severe active rheumatoid arthritis with inadequate response to methotrexate…
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Monoclonal antibodies are transforming therapeutics through their highly efficient targeting mechanisms. There is a wide range of uses for monoclonal antibodies, including diagnosis, therapy, and research
In 2021, the monoclonal antibody therapy market size was valued at $178.5B and is envisioned to reach $451.89B by 2028, displaying a CAGR of 14.1%. Humira was the…
The emergence of the coronavirus SARS-CoV-2 and the COVID-19 pandemic has spurred global healthcare and life sciences companies- as well as government agencies- to partner at unprecedented speed to develop vaccines- treatments- and kits
This article covers the last six months of deal data provided by Chris Dokomajilar of DealForma
During the last six months…

