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CSL announced that the FDA accepted its Biologics License Application (BLA), and the EMA has accepted its Marketing Authorisation Application (MAA), for CSL312 (garadacimab) to treat prophylactic treatment for hereditary angioedema (HAE).  If approved, CSL312 would be the f...

Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that its phase III clinical trial of CT-P47, biosimilar to Genentech’s Actemra®/Roactemra® (tocilizumab), demonstrated equivalence with the originator product in patients with r...

Amgen announced that the FDA has accepted for priority review its Biologics License Application (BLA) for tarlatamab to treat patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.  The FDA assigned a PDUFA goa...

Eisai and Biogen announced that Leqembi® intravenous infusion (lecanemab) will be launched in Japan on 20 December 2023, after it was scheduled on the Japan National Health Insurance (NHI) Drug Price List.  Leqembi® intravenous infusion was approved in Japan on 25 September...

Sandoz subsidiary Lek announced it has commenced construction of its US$400M biopharmaceutical production centre in Lendava, Slovenia.  The facility aims to be Europe’s most efficient producer of active pharmaceutical ingredients for biologics, and will have approximately 4...

Celltrion USA announced that large Medical Benefits Manager Ventegra® will add Vegzelma®, Celltrion’s biosimilar to Genentech’s Avastin® (bevacizumab) on its commercial formulary as a preferred brand. Vegzelma® (bevacizumab-adcd) was approved by the FDA to treat six types o...

Lotus Pharmaceutical announced that it has entered into a partnership with Intas Pharmaceuticals for the commercialisation of Intas’s Prolia® (denosumab) biosimilar in South Korea, Taiwan and certain markets in South East Asia.  According to the announcement, Intas will be ...

The FDA approved Vertex/CRISPR Therapeutics’ Casgevy® and Bluebird Bio’s Lyfgenia®, the first cell-based gene therapies to treat sickle cell disease in patients 12 years and older.  Casgevy® is the first FDA-approved treatment that uses CRISPR/Cas9 to genetically modify a p...

Bio-Thera announced that its Avzivi® (BAT1706), biosimilar to Genentech’s Avastin® (bevacizumab) is FDA approved with a full indication set (excluding hepatocellular carcinoma).  Bio-Thera is the only Chinese company to have received marketing approval for a biosimilar in t...