Dipanshu Dixit
Shots:
Formycon has reported that Klinge Biopharma, holder of global rights to its FYB203 (biosimilar, Eylea), has granted exclusive commercialization rights to Actor Pharmaceuticals for Australia and to Megalabs for LATAM. Regulatory filing is submitted to Australia’s TGA, and Formycon is preparing approval applications with Megalabs for LATAM
As per the deal, Klinge will receive…
Shots:
PharmaShots has compiled a list of US FDA-approved drugs in the month of September 2025
The US FDA has approved a total of 6 new drugs, including 5 new molecular entities and 1 biologic, leading to the treatment of patients and advances in the pharmaceutical industry
The major highlighted drug was Merck’s Keytruda Qlex,…
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Biosimilars are developed to match approved biologic therapies in safety, and efficacy, ensuring comparable clinical outcomes. They represent a critical pathway to reducing healthcare costs by providing affordable alternatives to expensive branded biologics, delivering meaningful savings for both patients and payers
In a key development, Henlius and Organon secured U.S. FDA approval for Bildyos…