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Biogen and Eisai announced that the FDA has approved the supplemental Biologics License Application (sBLA) for LEQEMBI® (lecanemab-irmb) to treat Alzheimer’s disease (AD).  On 9 June 2023, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee unanimously ...

Biocon Biologics announced it has completed the integration of Viatris’ biosimilars business in over 70 countries in ‘emerging markets’.  This signifies completion of the first stage of implementation of the Biocon buy out, wherein Viatris’ biosimilar operations were ...

A Hisun phase I study has demonstrated pharmacokinetic similarity and bioequivalence between HS628, a proposed tocilizumab biosimilar to Genentech’s Actemra®.  The safety and immunogenicity profiles of HS628 were also found to be similar to the reference product in healthy ...

Aurobindo Pharma announced that CuraTeQ Biologics’ BP02 showed equivalence to Genentech’s Herceptin® in its phase III clinical trial.  The study’s results indicated that BP02 has clinical response equivalence (pharmacokinetics and immunogenicity) and comparable safety profi...

Samsung Biologics announced it has reached two agreements with Pfizer to manufacture its biosimilar products for oncology, inflammation and immunotherapy until 2029 in new South Korean Plant 4.

These announcements include a $704M contract and an additional $193M agre...

Organon and Samsung Bioepis announced that Hadlima®, biosimilar to AbbVie’s Humira® (adalimumab), is now available in the US.  Hadlima® is available at a list price of $1,038, an 85% discount in comparison to the list price of Humira®.  Samsung Bioepis announced a global se...