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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’ AIO-001 is a...

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 for ad...

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 expects R...

AGC Biologics announced that it will construct a new manufacturing facility for biologics and advanced therapy medicinal products (ATMPs) in Yokohama Japan.  It expects the site to be operational in 2026.

The 20,000 m² facility will offer pre-clinical through to comm...

Accord BioPharma, a wholly-owned subsidiary of Intas Pharmaceuticals, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115, its proposed biosimilar to Janssen’s Stelara®.

DMB-3115 was jointly devel...

Samsung Bioepis, Celltrion and Formycon have filed responses to Regeneron’s Motion for Alternative Service in each of their respective matters before the United States District Court for Northern District Of West Virginia regarding biosimilars to Eylea® (aflibercept).  Rege...

Glenmark Pharmaceuticals announced it has launched Lirafit®, the biosimilar to Novo Nordisk’s Victoza®/Saxenda® (liraglutide) in India.  Liralift® is priced at around INR100 for a standard dose (~AUD$1.80), a 70% price reduction compared to the originator product.  Lirafit®...

Alexion filed a complaint against Samsung in the US District Court for the District of Delaware asserting infringement of six US eculizumab patents.  The allegations relate to Samsung’s abbreviated Biologics License Application (aBLA)  for SB12, its biosimilar to Alexion’s ...

Alvotech announced positive top-line results for AVT06, its biosimilar to Regeneron’s Eylea® (aflibercept).   The study was a randomised, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 c...