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As previously reported, on 6 May 2024, the United States District Court for the District of Delaware refused to grant Alexion preliminary injunctive relief against Samsung Bioepis for alleged infringement of claims of two Alexion patents relating to methods for treating par...

On 17 June 2024, Merck (known as MSD outside the US and Canada) announced that the US FDA has approved its anti-PD-1 therapy, Keytruda® (pembrolizumab) in combination with carboplatin and paclitaxel for primary advanced or recurrent endometrial carcinoma. 

This is th...

On 15 June2024, Ophthalmology and Therapy published the results of a Samsung Bioepis-sponsored study which assessed the analytical similarity between Samsung Bioepis’ aflibercept biosimilar, SB15, and Regeneron’s Eylea® (aflibercept) sourced from the US and EU.  The results...

On 14 June 2024, Australia’s Therapeutic Goods Administration (TGA) approved Regeneron’s and Bayer’s Eylea® (aflibercept) 8mg intravitreal injection for nAMD and DME. 

High dose Eylea® has previously been approved in multiple countries including the US (August 2023 –...

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...