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As previously reported, on 27 December 2023, and in a judgment published on 31 January 2024, the US District Court for the Northern District of West Virginia held that Mylan and Biocon infringed eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of...

On 11 April 2024, the United States Judicial Panel on Multijurisdictional Litigation ruled that patent infringement actions brought by Regeneron regarding aflibercept biosimilars by Amgen, Mylan, Celltrion, Samsung Bioepis (2 actions) and Formycon involved “common questions...

On 12 April 2024, Korea Biomedical Review reported that Samsung Bioepis received Korean approval for EpyztekTM(SB17), biosimilar to Janssen’s Stelara® (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.  Epyztek...

On 11 April 2024, Formycon AG and Bioeq AG announced the launch of Lucentis® (ranibizumab)  biosimilar FYB201 in Canada and Switzerland.  Health Canada granted marketing authorization under the tradename RanoptoTM, and Swissmedic has approved FYB201 under the tradename Rani...

On 11 April 2024, Business Korea published that Celltrion has been granted a formulation patent (US 11 951 207) for its ZYMFENTRA®. ZYMFENTRA® is the world’s first self-developed subcutaneous injection of infliximab for treating autoimmune diseases.  Celltrion claims ...

Boston-based Ginkgo Bioworks announced on 10 April 2024 an expansion of its partnership with global healthcare leader, Novo Nordisk. This extended collaboration, set to span five years, is targeting improving the manufacturing of Novo Nordisk’s medicines with a focus ...

On 10 April 2024, as a result of a settlement between the parties, the US District Court for the District of New Jersey dismissed all patent infringement claims in the proceeding brought by Genentech, Hoffmann-La Roche and Biogen against Dr Reddy’s Laboratories and Freseniu...

On 8 April 2024, Samsung Bioepis released its fifth US Biosimilar Market Report.  The quarterly report details average sales price information for US launched biosimilars and market share and price trends.
The Q2 2024 Report notes that as of April 2024, the FDA has ap...