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Significant biosimilar activities this week include: 01 April 2023 | AU | Humira® 24.39% PBS price drop 30 March 2023...
The High Court recently issued its decision in the case of Self Care IP Holdings Pty Ltd & Anor v Allergan...
EMA recommended granting marketing authorisation for Samsung Bioepis’ Epysqli™ (eculizumab), biosimilar to Alexion’s...
Two biosimilars are on the July 2023 PBAC meeting agenda seeking to be PBS reimbursed for Australia: Cipla Australia...
Daiichi Sankyo announced that its Enhertu® (trastuzumab deruxtecan) has been approved by Japan’s Ministry of Health,...
Eli Lilly has announced a $1B investment to build a new biotech facility in Raheen (Ireland) for the manufacture of...
The Supreme Court heard the opening oral arguments in the Amgen v Sanofi case (2020-1074; No. 21-757) this week. The...
Significant biosimilar activities this week include: 22 March 2023 | US | PTAB institutes Celltrion and Samsung IPRs...
Coya Therapeutics, Inc. announced an exclusive worldwide licensing agreement with Dr Reddy’s Laboratories, Ltd for...
Significant biosimilar activities this week include: 01 March 2023 | CA | Study finds nonmedical switching policy did...
A central tenet of patent interpretation under Australian law is that the specification should be a given a purposive...
Significant biosimilar activities this week include: 09 March 2023 | EU | Sandoz signs MOU for USD$400M biologics...
In this patent infringement/validity dispute, Hanwha failed to establish that REC infringed its “old Act” Australian patent No 2008323025, and its dependant ACL claims were dismissed.
Significant biosimilar activities this week include: 28 February 2023 | IN | Enzene Biosciences begins supply of...
The ‘Increasing Access to Biosimilar Act of 2023’ (HR 1352) was introduced into the US House of Representatives. The...
Significant biosimilar activities this week include: 22 February 2023 | EU | AbbVie sued by Dutch group over Humira®...