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Mar 4, 2024
Amgen announced that Wezlana™ (ustekinumab injection) and Wezlana™ (ustekinumab for injection, solution for intravenous infusion), biosimilar to Janssen’s Stelara®, is now available in Canada. Wezlana™ is the first biosimilar to be approved by Health Canada for all...
Mar 4, 2024
Biocon announced a settlement with Regeneron and Bayer under which it can launch its Yesafili® (aflibercept), biosimilar to Regeneron’s Eylea®, in Canada from 1 July 2025. The settlement resolves multiple patent infringement proceedings in the Federal Court of Canda...
Mar 4, 2024
On 4 March 2024, Sandoz announced that Health Canada approved Wyost® as biosimilar to, and for all indications of, Amgen’s Xgeva® (denosumab). This follows the Canadian approval of Sandoz’s Jubbonti®, biosimilar to Amgen’s Prolia® (denosumab) in February 2024 for...
Mar 4, 2024
On 4 March 2024, Merck Sharp & Dohme, LLC filed petitions for inter partes review against four Johns Hopkins University (JHU) patents relating to methods of treatment using pembrolizumab in patients whose cancers have a genetic instability called microsatellite...
Mar 1, 2024
The Australian Financial Review reported that on 1 March 2024 TGA investigators raided Como Compounding Pharmacy in Melbourne and seized ‘off-brand’ Ozempic® (semaglutide) and other allegedly unlawfully made medications. As reportedly revealed in a confidential TGA...
Mar 1, 2024
On 1 March 2024, JAMP Pharma announced that it launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada. Jamteki™ was approved by Health Canada in November 2023 and JAMP’s launch follows a settlement between Alvotech and J&J last month regarding...
Feb 29, 2024
The Medicines and Healthcare Regulatory Agency issued a safety update regarding (dupilumab) and ocular side effects. The regulator warned that side effects can include conjunctivitis and ulcerative keratitis.
Feb 29, 2024
On 29 February 2024, Biocon Biologics Ltd, announced a settlement with J&J and Janssen, under which it can launch its Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in the USA from February 2025. The FDA previously accepted for review Biocon’s...
Feb 29, 2024
On 29 February 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for Xgeva® (denosumab) as a 120mg solution for injection in a prefilled syringe. This Xgeva PFS product is a high concentration product which is a line...
Feb 28, 2024
On 28 February 2024, Celltrion announced that it filed an application with MFDS for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab). The application seeks registration across the full Actemra® label and is based on Phase 3 results confirming equivalence of...
Feb 28, 2024
On 28 February 2024, Celltrion announced that its first batch of Zymfentra® (SC infliximab) arrived in Atlanta, with three more shipments expected to arrive by early March this year. Zymfentra® was approved by the FDA in October 2023. Zymfentra® (SC infliximab),...
Feb 27, 2024
On 27 February 2024, Akeso announced results of a Phase II clinical trial for cadonilimab combined with standard treatment (chemotherapy +/- bevacizumab) for treating recurrent/metastatic cervical cancer. The results were published in the American Association for...
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