BIOSIMILARS UPDATES

26 MAY 2023 | EU | Celltrion files MAA with EMA for biosimilar to Janssen’s Stelara® (ustekinumab) Korea Biomed has reported that Celltrion filed a marketing authorisation application with the EMA for CT-P43, its biosimilar to Janssen’s Stelara®...

22 MAY 2023 | US | Janssen and Amgen settle Stelara® (ustekinemab) biosimilar patent dispute The US District Court of Delaware has dismissed with prejudice.  The parties agreed to dismiss the action with prejudice and each party will bear its...

11 MAY 2023| EU | Celltrion to supply Vegzelma® (bevacizumab) in Italy and Belgium Korea Biomed has reported that Celltrion Healthcare has won bids to supply Vegzelma®, biosimilar to Genentech’s Avastin® (bevacizumab), in Italy and Belgium to...

04 MAY 2023 | CN | Boan Biotech commences phase III clinical trials for Prolia®/Xgeva® (denosumab) biosimilar Luye Pharma announced that it has enrolled its first subject in an international multi-center Phase 3 clinical study for its internally...

28 April 2023 | US | FDA advisory committee supports approval of Merck’s Lynparza® (olaparib) combination for first line treatment of prostate cancer Merck announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to support...

20 April 2023 | CA | New indication alert: Health Canada issues notice of compliance for Regeneron/Sanofi’s Dupixent® (dupilumab) in children > 6 months Sanofi and Regeneron announced that Health Canada issued a Notice of Compliance for...

Significant biosimilar activities this fortnight include: 13 April 2023 | US | Alvotech CRL provided to FDA regarding high concentration buffer free biosimilar adalimumab 12 April 2023 | AU | Samsung Bioepis files opposition to Janssen’s...

Significant biosimilar activities this week include:01 April 2023 | AU | Humira® 24.39% PBS price drop 30 March 2023 | EU | EMA CHMP gives nod to Samsung Bioepis’ Epysqli™ eculizumab biosimilar 29 March 2023 | AU | Cipla/Alvotech’s biosimilar...