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On 14 June 2024, the Patent Trial and Appeal Board (PTAB) issued a final decision in Samsung Bioepis’ Inter Partes Review Proceeding (IPR2023-00442) relating to Regeneron’s US Patent No. 10,130,681 (‘681 patent) covering methods of treatment involving Eylea® (aflibercept). ...

On 13 June 2024, the Korea Herald reported that Celltrion’s Steqeyma (CT-P43), biosimilar to J&J’s Stelara® (ustekinumab), has been approved by the South Korean Ministry of Food and Drug Safety for all indications of Stelara®.  No launch date has been announ...

On 13 June 2024, Adalvo announced its liraglutide pre-filled pen has been approved in the EU, making it the first EU approved generic liraglutide.  Originator Novo Nordisk supplies liraglutide as Victoza® in EU which is indicated for the treatment of type 2 diabetes. Adalvo...

On 13 June 2024, Formycon announced that it has commenced Phase 1 trials for its FYB206, biosimilar to Merck’s (MSD) blockbuster Keytruda® (pembrolizumab), in malignant melanoma.  A parallel Phase 3 trial, yet to commence, will compare the safety and efficacy of FYB206 with...

On 13 June 2024, at the Annual European Congress of Rheumatology, Celltrion announced positive Phase III results for CT-P47, a biosimilar referencing RoActemra®, in patients suffering from moderate-to-severe rheumatoid arthritis. The Phase III comparative clinical trial dat...

On 12 June 2024, Boston-based Zumutor Biologics announced that it has commenced its open-label, first-in-human, multicentre, Ph 1 trial of ZM008 in patients with advanced solid tumours.  The trial (NCT06451497) is evaluating ZM008 alone and in combination with pembrolizumab...

On 11 June 2024, Japan’s Ono Pharma announced completion of its acquisition of US biopharmaceuticals company Deciphera for approximately $2.4 billion.   

Ono plans to leverage Deciphera’s oncology research and development capabilities, as well as its sales pres...

On 11 June 2024, Judge Kleeh of the US District Court for the Northern District of West Virginia made a permanent injunction order against Biocon in the dispute brought by Regeneron in relation to patents relating to aflibercept.  The order is currently sealed. 

As p...

On 11 June 2024, Alvotech announced that it has expanded its current partnership with STADA to include AVT03  (denosumab), biosimilar to Amgen’s Prolia®/Xgeva®.   

Under the agreement, STADA will be the sponsor of the Alvotech developed product, with semi-exclusive r...