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Recent BioBlast® Updates

WuXi Biologics and BioNTech Ink $20M Deal for Two Monoclonal Antibodies

Jan 11, 2024

WuXi Biologics announced that it has signed a research service agreement with BioNTech under which Wuxi will receive a $20M upfront payment, and BioNTech is granted exclusive rights to develop therapeutic candidates from two undisclosed preclinical investigational...

Scientific Advisory Group to Discuss Eisai/Biogen’s MAA for Leqembi® (lecanemab)

Jan 11, 2024

Eisai announced that the Scientific Advisory Group (SAG) will meet to discuss Eisai’s marketing authorisation application (MAA) for Leqembi® (lecanemab) which is under review by the European Medicines Agency (EMA). The SAG is expected to meet before 31 March 2024. ...

Celltrion Applies to FDA for Interchangeable Status for Yuflyma® Biosimilar to AbbVie’s Humira® (adalimumab)

Jan 11, 2024

Celltrion announced in a corporate filing that it applied to the FDA seeking interchangeable status for CT-P17 (Yuflyma®), biosimilar to AbbVie’s Humira® (adalimumab), on 9 January 2024. On 2 October 2023 the FDA approved Celltrion’s Yuflyma® in 20mg (pre-filled...

Regeneron Sues Amgen over ABP938 Biosimilar to Eylea®

Jan 10, 2024

Regeneron filed a Compliant in the US District Court for the Central District of California against Amgen asserting infringement of 32 aflibercept patents. The Complaint states that on 31 October 2023, Amgen announced that the FDA accepted its abbreviated Biologics...

First Biosimilar Alert: EC Approves Alvotech/STADA’s Uzpruvo® (AVT04) Biosimilar to Janssen’s Stelara® (ustekinumab)

Jan 10, 2024

Alvotech and STADA announced the European Commission (EC) has granted centralised marketing authorisation (MA) for Uzpruvo® (AVT04), the first EU-approved biosimilar to Janssen’s Stelara® (ustekinumab). The marketing authorisation is valid in all European Economic...

Celltrion Presents Strategic Vision & Growth Plan at JP Morgan Conference

Jan 10, 2024

Celltrion announced the next phase of its strategic transformation to focus on new drug development at the JP Morgan Healthcare Conference in San Francisco, California. Celltrion discussed the company's strategic priorities and progress, including its vision to move...

PTAB Finds Two Regeneron Eylea® (aflibercept) Patents Invalid

Jan 9, 2024

The Patent Trial and Appeal Board (PTAB) in found that Regeneron’s patents 10,130,681 and 10,888,601 relating to methods of treatment using Eylea® (aflibercept) are invalid. The PTAB held in IPR2022-01225 and IPR2022-01226 that all challenged claims of the two...

Study Demonstrates Switching from AbbVie’s Humira® (adalimumab) to Samsung Bioepis’ Biosimilar, Adalloce®, is Safe and Efficacious in NIU

Jan 9, 2024

A study published in Ocular Immunology and Inflammation found that switching patients with non-infectious uveitis (NIU) from AbbVie’s Humira® to Samsung Bioepis’ Adalloce® (SB5) did not result in clinically significant efficacy or safety differences. The study was...

Approval Alert: Biogen/Eisai’s Leqembi® (lecanemab) Approved by NMPA to Treat Alzheimer’s Disease

Jan 9, 2024

Biogen and Eisai announced that Leqembi® (lecanemab) has been approved by the National Medical Products Administration (NMPA) in China for the treatment of mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia. Eisai has begun preparation for...

GSK Acquires Aiolos Bio for $1B Including mAb AIO-001 in Phase II Studies

Jan 9, 2024

GSK and Aiolos Bio announced they have entered into an agreement for GSK to acquire Aiolos, a clinical-stage biopharmaceutical company focused on addressing respiratory and inflammatory conditions, for $1B upfront and up to $400M in milestone payments. Aiolos’...

EC Grants MA to Bayer’s Eylea® 8mg (aflibercept) for nAMD and DMO

Jan 8, 2024

Bayer announced that the European Commission (EC) granted marketing authorisation (MA) for Eylea® 8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DMO). Eylea® 8 mg is approved...

Celltrion’s Remsima SC®, Biobetter to Remsima®, Biosimilar to Janssen’s Remicade® (infliximab), Sales Jump 48%

Jan 5, 2024

The Korea Biomedical Review has reported that Celltrion confirmed it has increased Australian sales of Remsima SC®, biobetter to Remsima® (IV product), biosimilar to Janssen’s Remicade® (infliximab), in the first nine months of 2023 by 48% year on year. Celltrion...

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Recent BioBlast® Updates

WuXi Biologics and BioNTech Ink $20M Deal for Two Monoclonal Antibodies

Scientific Advisory Group to Discuss Eisai/Biogen’s MAA for Leqembi® (lecanemab)

Celltrion Applies to FDA for Interchangeable Status for Yuflyma® Biosimilar to AbbVie’s Humira® (adalimumab)

Regeneron Sues Amgen over ABP938 Biosimilar to Eylea®

First Biosimilar Alert: EC Approves Alvotech/STADA’s Uzpruvo® (AVT04) Biosimilar to Janssen’s Stelara® (ustekinumab)

Celltrion Presents Strategic Vision & Growth Plan at JP Morgan Conference

PTAB Finds Two Regeneron Eylea® (aflibercept) Patents Invalid

Study Demonstrates Switching from AbbVie’s Humira® (adalimumab) to Samsung Bioepis’ Biosimilar, Adalloce®, is Safe and Efficacious in NIU

Approval Alert: Biogen/Eisai’s Leqembi® (lecanemab) Approved by NMPA to Treat Alzheimer’s Disease

GSK Acquires Aiolos Bio for $1B Including mAb AIO-001 in Phase II Studies

EC Grants MA to Bayer’s Eylea® 8mg (aflibercept) for nAMD and DMO

Celltrion’s Remsima SC®, Biobetter to Remsima®, Biosimilar to Janssen’s Remicade® (infliximab), Sales Jump 48%

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