The British Generics and Biosimilars Associations (BGMA) has released a report finding that the NHS is projected to...
Sandoz Positive Results From MYLIGHT Aflibercept (Eylea® biosimilar) Ph III Trials
Sandoz published the results from MYLIGHT Ph III trials of its biosimilar aflibercept in patients with wet macular...
Gilead And Tentarix Enter Three Collaboration Agreements Worth US$66M To Develop Cancer And Inflammation Biologics
Gilead and Tentarix Biotherapeutics announced have entered three multi-year agreements to leverage Tentarix’s...
Biocon Biologics Confirms Viatris North American Transition Will Complete By End Q3 2023
According to the Business Standard Biocon Biologics’ CEO has confirmed the transition of the North American part of...
FDA Grants Zumutor IND For Novel Mab ZM008 And Pembrolizumab Against Multiple Solid Cancers
Zumutor Biologics announced that FDA has granted its Investigational New Drug (IND) application for ZM008 (IgG1...
Amgen Appeals Alexion’s Preliminary Injunction Order Regarding Off-label Use of Eculizumab (Soliris®) Biosimilar Bekemv® in Germany
Managing IP has reported that Amgen filed an appeal with Germany’s Federal Court of Justice against a preliminary...
FDA Publishes Draft Guidance For Biosimilar Supplement Classifications
On 10 August 2023, the FDA published draft guidance for industry ‘Classification Categories for Certain Supplements...
Regeneron Publishes 96 Week Results of Aflibercept 8mg In wAMD
On 10 August 2023, Regeneron announced the results of two-year (96 week) data from its PULSAR trials investigating...
UPC Appoints 21 Additional Technically Qualified Judges
The UPC has appointed 21 new technically qualified judges (TQJs) across various areas, including chemistry and...
Samsung Bioepis IPR Terminated Following Agreement With Janssen For Stelara® (ustekinumab)
The USPTO Patent Trial and Appeal Board has terminated Samsung Bioepis’s Inter Partes Review (IPR) challenging...
Puerto Rico Economic Development Bank grants US$3.85M to Biosimilar Sciences and OcyonBio
News is my Business reported that the Puerto Rico Economic Development Bank (BDE) has approved US$3.85M in funding for...
Celltrion’s Aflibercept IPR Terminated After Regeneron Disclaims Patent
Regeneron filed an unopposed motion to terminate IPR2023-00620 after disclaiming all claims of the US process patent...
Fresenius & Formycon Settle with J&J in US Over Ustekinumab Enabling Sales from no later than 15 April 2025
Fresenius Kabi and Formycon AG announced they reached a settlement in the US with Johnson & Johnson relating to...
Gingko Bioworks & Merck Announce US$490M Collaboration For Biologics
On 7 August 2023 Gingko Bioworks and Merck announced a collaboration to improve biologic manufacturing. Gingko will...
Teva confirms intention to launch US adalimumab biosimilar AVT02 in 2024
Teva’s CEO confirmed that it will still pursue launching its Alvotech developed adalimumab biosimilar of AbbVie's...
Coherus’ Q2 2023 Financial Results Show Quadrupling of Cimerli® (Ranibizumab) Sales Since Last Quarter
Coherus BioSciences announced its Q2 2023 financial results, reporting that sales of its Cimerli® (ranibizumab),...