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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 Stelara...

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 involv...

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 ost...

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 instabil...

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 letter ...

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 usteki...

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. 

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 Biologics Lic...

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 exten...