Read our latest updates & insights

Samsung Bioepis filed an IPR petition against Regeneron’s US10,464,992 relating to formulations of aflibercept.  Samsung Bioepis has sought joinder with the Celltrion IPR filed against the same Regeneron patent on 17 January 2023.

Samsung Bioepis has previously filed...

Celltrion Group revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that Celltrion, Inc. and Celltrion Health Co., Ltd will merge as part of the initial phase of its merger plan.  Following this stage, the company will proceed with the sec...

The British Generics and Biosimilars Associations (BGMA) has released a report finding that the NHS is projected to lose out on approximately £100M in savings per year by 2028 due to reduced biosimilar competition on the 85 biologics which are due to lose patent exclusivity...

Sandoz published the results from MYLIGHT Ph III trials of its biosimilar aflibercept in patients with wet macular degeneration.  Sandoz reported that the study met its primary efficacy endpoint and showed no clinically meaningful differences to Regeneron’s Eylea®.  Sandoz ...

Gilead and Tentarix Biotherapeutics announced have entered three multi-year agreements to leverage Tentarix’s Tentacles® platform to discover and develop multi-functional, conditional protein therapeutics for oncology and inflammatory diseases.  Gilead said that the collabo...

According to the Business Standard Biocon Biologics’ CEO has confirmed the transition of the North American part of Viatris’ global biosimilars business to Biocon Biologics will complete by the end of this quarter, less than a year after the companies signed a $3.34B acquis...

Zumutor Biologics announced that FDA has granted its Investigational New Drug (IND) application for ZM008 (IgG1 monoclonal antibody) to initiate a phase I clinical study for the treatment of multiple solid cancers. The FDA approved the use of a staggered parallel clinical d...

Managing IP has reported that Amgen filed an appeal with Germany’s Federal Court of Justice against a preliminary injunction order made by the Munich District Court on 4 August 2023.  The preliminary injunction prevents Amgen from supplying Bekemv®, its biosimilar to Alexio...

On 10 August 2023, the FDA published draft guidance for industry ‘Classification Categories for Certain Supplements Under BsUFA III’ seeking comment and suggestions by 10 October 2023.

The guidance provides recommendations for applicants and FDA review staff on six c...