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Apr 18, 2024
On 18 April 2024, Takeda announced FDA approval of subcutaneous administration of ENTYVIO® (vedolizumab) for maintaining therapy in adults with moderately to severely active Crohn’s disease (CD). This follows the FDA's acceptance of Takeda's BLA for ENTYVIO® for the...
Apr 18, 2024
On April 2024, Korean Biomedical Review reported that Celltrion won the Denmark national tender for its subcutaneous infliximab formulation, Remsima SC®. Remsima SC® (infliximab) will be supplied in Denmark for one year by Celltrion's Danish subsidiary. This...
Apr 17, 2024
On 17 April 2024, Biocon announced that it signed an exclusive licensing and supply agreement for generic Ozempic® (semaglutide) in Brazil. Biocon will develop, manufacture and supply the semaglutide product and Biomm is responsible for regulatory and...
Apr 16, 2024
On 16 April 2024, Alvotech announced the US has approved SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara®(ustekinumab), for both adult and paediatric use. Selarsdi™ was developed by Alvotech and will be commercialised by Teva in the US. This is the second US...
Apr 16, 2024
The Korea Biomedical Review reports that, on 16 April 2024, Merck Sharp & Dohme (MSD) announced that it obtained approval in Korea for an expanded indication for its Keytruda® (pembrolizumab) as a combination therapy with chemoradiotherapy for treating FIGO...
Apr 15, 2024
On 15 April 2024, Fresenius Kabi announced its US launch of Tyenne® (tocilizumab-aazg), biosimilar to Roche’s Actemra® (tocilizumab) in an intravenous formulation. Both IV and subcutaneous forms of Tyenne were FDA approved on 5 March 2024. Tyenne is the third...
Apr 15, 2024
The Korea Times reports that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to Amgen’s Prolia® (denosumab), at the World Congress on Osteoporosis held in London from 11-14 April 2024. It is reported that the clinical trial showed...
Apr 12, 2024
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...
Apr 12, 2024
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...
Apr 12, 2024
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. ...
Apr 11, 2024
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...
Apr 11, 2024
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...
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