Recent BioBlast® Updates

Novo Nordisk Presents 21 Abstracts at EU Diabetes Meeting, Including Results of IcoSema and Semaglutide Trials

Sep 6, 2024

On 6 September 2024, Novo Nordisk announced its presentation of 21 abstracts and other data at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) held from 9 to 13 September 2024. The data to be presented include results from the...

Celltrion Plans: 11 New Biosimilars Approved by 2025, Portfolio of 22 by 2030

Sep 6, 2024

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...

Evernorth to Supply Ustekinumab Biosimilar to Accredo Patients in US with No Out-of-Pocket Costs

Sep 5, 2024

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...

Novo Nordisk Sues Sun Pharmaceutical and Mylan in US Over Generic Wegovy® (Semaglutide)

Sep 5, 2024

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...

Outlook Therapeutics Completes Patient Enrolment for Ophthalmic Bevacizumab Trials

Sep 4, 2024

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...

MSD and EyeBio Announce Phase 2b/3 Clinical Trial of Restoret™ (MK-3000) for Diabetic Macular Oedema

Sep 4, 2024

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 an...

EC and UK’s MHRA Approve Celltrion’s Ustekinumab Biosimilar

Sep 4, 2024

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 its...

MSD’s Keytruda® Plus Pfizer/Astellas’ Padcev® Approved in EU for Urothelial Carcinoma

Sep 3, 2024

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...

Sandoz Set For 2026 Generic Semaglutide Launch in Canada

Sep 3, 2024

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...

Shanghai Henlius’ Biosimilar Pembrolizumab Clinical Trial Approved in China

Sep 2, 2024

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...

Pfizer’s Biosimilar Adalimumab PBS-Listed in Australia

Sep 1, 2024

On 1 September 2024, the PBS published its Summary of Changes, which included listing Pfizer’s Abrilada®, biosimilar to AbbVie’s Humira® (adalimumab), on the PBS in 40mg/0.8mL injections and 2 x 0.8 ml syringes. This comes three years after Abrilada was first...

PD-(L)1 Inhibitors on the Agenda for PBAC’s September Intracycle Meeting

Sep 1, 2024

On 1 September 2024, the PBS published its agenda for the September PBAC Intracycle Meeting, which will include an item providing for “initial guidance on parameters that need to be considered for future broad PBS listing proposals for PD-(L)1 inhibitors, and to...

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Recent BioBlast® Updates

Novo Nordisk Presents 21 Abstracts at EU Diabetes Meeting, Including Results of IcoSema and Semaglutide Trials

Celltrion Plans: 11 New Biosimilars Approved by 2025, Portfolio of 22 by 2030

Evernorth to Supply Ustekinumab Biosimilar to Accredo Patients in US with No Out-of-Pocket Costs

Novo Nordisk Sues Sun Pharmaceutical and Mylan in US Over Generic Wegovy® (Semaglutide)

Outlook Therapeutics Completes Patient Enrolment for Ophthalmic Bevacizumab Trials

MSD and EyeBio Announce Phase 2b/3 Clinical Trial of Restoret™ (MK-3000) for Diabetic Macular Oedema

EC and UK’s MHRA Approve Celltrion’s Ustekinumab Biosimilar

MSD’s Keytruda® Plus Pfizer/Astellas’ Padcev® Approved in EU for Urothelial Carcinoma

Sandoz Set For 2026 Generic Semaglutide Launch in Canada

Shanghai Henlius’ Biosimilar Pembrolizumab Clinical Trial Approved in China

Pfizer’s Biosimilar Adalimumab PBS-Listed in Australia

PD-(L)1 Inhibitors on the Agenda for PBAC’s September Intracycle Meeting

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