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On 6 September 2024, Celltrion’s CEO, Seo Jin-seok, announced at the 22nd Morgan Stanley Global Healthcare Conference that it plans to obtain approval for 11 biosimilar products by 2025, with an aim to have a “portfolio of 22 products by 2030”.

Celltrion has 8 biosim...

On 5 September 2024, Cigna Group member, Evernorth, announced that it will offer biosimilar ustekinumab to US patients through its specialty pharmacy, Accredo, with no patient out-of-pocket costs.  The biosimilar offering, available beginning in early 2025, will be offered ...

On 5 September 2024, Novo Nordisk filed separate lawsuits in the US District Court for the District of Delaware against each of Sun Pharmaceutical and Mylan asserting infringement of US patent number 12,029,779 (granted 9 July 2024), which claims a method of reducing body w...

On 4 September 2024, Outlook Therapeutics announced that it has completed patient enrolment in its NORSE EIGHT clinical trial assessing the effectiveness of ONS-5010/Lytenava™ (bevacizumab-vikg, bevacizumab gamma) for use in wet AMD.  The trial is the final step required be...

On 4 September 2024, Merck (MSD) and EyeBio announced the initiation of the phase 2b/3 BRUNELLO trial (NCT06571045) evaluating Restoret™ (MK-3000, formerly EYE103) for the treatment of diabetic macular oedema (DME).

Restoret™ is a tri-specific antibody that acts as a...

In the last 2 weeks, Celltrion has received marketing approvals in the European Union and the United Kingdom for its ustekinumab, SteQeyma® (CT-P43), biosimilar to Janssen’s Stelara®.

On 26 August 2024, Celltrion announced that the European Commission has approved it...

On 3 September 2024, MSD announced that Keytruda® (pembrolizumab) plus Pfizer/Astellas antibody drug conjugate Padcev® (enfortumab vedotin-ejfv) was approved by the European Commission (EC) for the first line treatment of unresectable or metastatic urothelial carcinoma.  Th...

On 3 September 2024, Bloomberg reported that Sandoz is planning a 2026 biosimilar semaglutide launch in Canada, reportedly after Novo Nordisk’s patent protection expires.  Sandoz launches in the US and Europe are not planned until the early 2030s.

This comes after Bi...

On 2 September 2024, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has approved an investigational new drug application (IND) for a clinical trial of HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab).  Henlius reports tha...