On 31 October 2023, the FDA approved Amgen’s Wezlana® (ustekinumab-auub), as the first FDA-approved biosimilar to...
New Indication Alert: FDA Approves Novartis’ Cosentyx® (secukinumab) for HS
Novartis announced that the FDA approved Cosentyx® (secukinumab) to treat moderate to severe hidradenitis suppurativa...
Sandoz Study Finds 8 Sandoz Biosimilars are Comparable to Originator Biologics
A Sandoz study published in Drug Safety found that eight Sandoz biosimilars (adalimumab (Hyrimoz®), epoetin alfa...
New Indication Alert: FDA Approves BMS’s Orenica® (abatacept) for JPsA
The FDA has approved Bristol Myers Squibb’s supplemental biologics license application (sBLA) for subcutaneous use of...
Aragen to Establish New US$30M Biologics Manufacturing Facility in India
Aragen announced it is establishing a new US$30M, 160,000m2 biologics manufacturing site in Bangalore, India. The...
EMA Validates BMS’s Type II Variation for Opdivo® (nivolumab)
Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its type II variation...
Dr Reddy’s Biologics Facility Receives Further Form 483 Objections Following US FDA Inspection
Dr Reddy’s informed the Indian National Stock exchange on 28 October 2023 that the FDA issued a Form 483 with ten...
Sanofi to Spin-Off Consumer Business and Focus on Biopharma by End Q4 2023
Sanofi announced that it will separate its Consumer Healthcare Business as soon as the end of Q4 2024, creating a...
July 2023 PBAC Public Summary Documents Available
The Department of Health and Aged Care has published the public summary documents considered at the July 2023 PBAC...
Approval Alert: Coherus/Shanghai Junshi’s Loqtorzi® (toripalimab) Approved to Treat NPC
Coherus BioSciences announced that the FDA has approved its Loqtorzi® (toripalimab) in combination with cisplatin and...
New Indication Alert: FDA Approves Roche’s Vabysmo® (faricimab) for Macular Oedema following Retinal Vein Occlusion RVO
Roche announced that the FDA has approved Vabysmo® (faricimab) to treat a new indication: macular oedema following...
NICE Recommends Novartis’ Cosentyx® (secukinumab) for Moderate to Severe HS
Novartis announced that the National Institute for Health and Care Excellence (NICE) issued final draft guidance...
German court issues preliminary injunction for Formycon’s Stelara® (Ustekinumab) Biosimilar
It has been reported that the Munich Regional Court has issued a preliminary injunction against Formycon’s manufacture...
Approval Alert: FDA Approves Eli Lilly’s Omvoh® (mirikizumab) to Treat Moderate to Severe UC
Eli Lilly announced that the FDA has approved its Omvoh® (mirikizumab-mrkz) for the treatment of moderately to...
Samsung Biologics’ Q3 Results: Highest Ever Quarterly Revenue Exceeding ₩1T, an 18% Increase YoY
Samsung Biologics has announced its Q3/2023 financial results, demonstrating its highest ever quarterly consolidated...
FDA Designates Samsung Bioepis/Biogen’s Ranibizumab Biosimilar as Interchangeable with Lucentis®
FDA has approved Samsung Bioepis’ sBLA for Byooviz®, as an interchangeable biosimilar to Genentech’s Lucentis®...