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Abbott announced it has entered into a commercialisation agreement with mAbxience for several biosimilars focusing on oncology, women’s health and respiratory diseases in emerging markets in Latin America, Southeast Asia, the Middle East and Africa.  The first molecul...

Biocon Biologics announced that Yesafili®, its biosimilar to Regeneron’s Eylea® (aflibercept), has received marketing approval from the European Commission (EC).  It was approved to treat various ophthalmic conditions such neovascular (wet AMD) age-related macular degenerat...

On 20 September, Alvotech announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for AVT02, a high-concentration, interchangeable biosimilar to AbbVie’s Humira® (adalimumab).  The BsUFA goal date for the resubmitted BLA is 24 February 2024. ...

Merck announced the US FDA accepted for priority review its supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA ®, Merck’s anti-PD-1 therapy, in a third cervical cancer indication.  The proposed indication is for KEYTRUDA ® in combination with ex...

BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a mutual agreement between the parties to terminate their previous collaboration and licence agreement entered into in January 202...

Fresenius Kabi announced that its Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra® has been approved by the European Commission (EC) for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis...

Korea Biomed reported that Rani Therapeutics has begun its phase I clinical trial for oral ustekinumab (RT-111) using Celltrion’s CT-P43 (ustekinumab), biosimilar to Janssen’s Stelara®.  Rani will evaluate pharmacokinetics and safety of RT-111 in up to 55 participants.

Samsung Biologics announced a new agreement with Bristol Myers Squibb for large-scale manufacturing of a BMS antibody cancer drug.  The agreement expands the existing 10-year manufacturing deal signed in 2013, as Samsung Biologics will manufacture the commercial antibody at...

The FDA has released draft industry guidance for biosimilar and interchangeable biosimilar product labeling.  The guidance includes proposed recommended approaches for:

product identification, including when to use the biosimilar or interchangeable biosimilar produ...