On 15 March 2024, the Australian Department of Health and Aged Care published the public summary documents considered...
CuraTeQ’s Omalizumab Biosimilar (BP11) Phase I Completion
On 15 March 2024, CuraTeQ Biologics (a subsidiary of Aurobindo) announced that it successfully completed phase I...
AstraZeneca to Acquire Amolyt Pharma for $1.05B
On 14 March 2024, AstraZeneca announced that it has entered into an agreement to acquire Amolyt Pharma, a...
Earnings for Sandoz Biosimilars Grow by 15% in 2023
On 13 March 2024, Sandoz reported double-digit growth of 15% in its 2023 biosimilar sales. Sandoz attributed this...
Regeneron Appeals PTAB Invalidity Findings for Two Aflibercept Patents
On 12 March 2024, Regeneron filed notices of appeal in the United States Court of Appeals for the Federal Circuit...
Biden Administration Proposes Biosimilar Substitution Without Interchangeability
The Biden Administration proposes to amend s352 of the Public Health Service Act so that all approved biosimilars are...
Celltrion Submits BLA for Interchangeable Omalizumab (Xolair®) Biosimilar
Celltrion announced that it has submitted an abbreviated Biologics License Application (A-BLA) in the US for approval...
Approval Alert: Formycon AG / MS Pharma’s Ranibizumab Biosimilar (Ravegza®) Approved in Saudi
On 11 March 2024, Formycon AG and MS Pharma announced that ranibizumab (FYB201 / Ravegza®), biosimilar to Genentech’s...
J&J Submits sBLA to FDA for TREMFYA® (guselkumab)
On 11 March 2024, Johnson & Johnson announced that it submitted a supplemental Biologics License Application...
Merck (MSD) Completes Acquisition of Harpoon Therapeutics for ~USD$650M
On 11 March 2024, Merck (MSD) announced the completion of the acquisition of Harpoon Therapeutics for about USD $650M...
Approval Alert: MSD’s Keytruda® (pembrolizumab) Approved in Korea for HER2-negative Gastric Cancer
On 11 March 2024, Korea Biomedical Review reported that Merck Sharp & Dohme (MSD)’s anti-PD-1 therapy Keytruda...
Approval Alert: FDA Approves Regeneron’s Praluent® (alirocumab) Injection for Treating Children with Genetic Form of High Cholesterol
On 11 March 2024, Regeneron announced that the FDA approved Praluent® (alirocumab) injection for treating children...
Eli Lilly’s ADmirable Lebrikizumab Study Shows Positive Results
On 10 March 2024, Eli Lilly announced results for its ADmirable lebrikizumab study. This is the first-of-its-kind...
Samsung Bioepis Presents Interchangeability Updates for its Adalimumab and Ustekinumab Biosimilars at AAD
On 9 March 2024, Samsung Bioepis presented two papers of study results for its immunology portfolio at the 2024...
NEW INDICATION ALERT: FDA Approves Novo Nordisk’s Wegovy® (semaglutide) for Cardiovascular Risk Reduction
Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse...
Regeneron’s High Dose Eylea® (aflibercept) With Extended Dosing Intervals May Reduce Treatment Burden
Regeneron announced one-year results from studies show that extended dosing regimens (12 or 16 weeks) for Regeneron’s...