Significant biosimilar activities this week include 30 Mar 20 | Biocad announced it had received registration certificates from Bosnia and Herzegovina for Acellbia® (rituximab) and Herticad® (trastuzumab), with a...
Significant biosimilar activities this week include March 20 | The UK High Court ruled filing errors in a Supplementary Protection Certificate (SPC) for Lucentis® (ranibizumab) have cut almost two years from...
Significant biosimilar activities this week include 16 Mar 20 | Teva and Celltrion launched Herzuma (trastuzumab) in the US. Herzuma is indicated for the treatment of breast cancer, metastatic breast cancer and...
Significant biosimilar activities this week include 09 Mar 20 | The FDA and FTC held a public workshop to further their efforts in creating a better biosimilar landscape in the US. The Centre for Biosimilars reported...
Significant biosimilar activities this week include 02 Mar 20 | Celltrion launched Remsima SC, its subcutaneous infliximab product, in the UK. To support the launch, Celltrion held a symposium at which it showcased the...
Significant biosimilar activities this week include 24 Feb 20 | The FDA launched a searchable version of the 'Purple Book', containing information about FDA licensed biological products. 24 Feb 20 | Canadian News...
As we previously foreshadowed, the innovation patent system has been given its end dates: 25 August 2021: last date to lodge innovation patents; and 25 August 2029: date on which last of the innovation patents will...
Significant biosimilar activities this week include 12 Feb 20 | Wockhardt announced divestment of assets to Dr Reddy's, under which 62 products and a manufacturing facility will be sold for $259 million. Wockhardt...
Significant biosimilar activities this fortnight include 05 Feb 20 | Merck announced a new spin-off company which will incorporate products from its Women's Health, Legacy Brands and Biosimilars businesses. The company...
Significant biosimilar activities this week include Jan 20 | Genentech and Roche commenced recruitment for Ph III clinical trials of their ranibizumab Port Delivery System (PDS) in patients with diabetic macular edema....
The Intellectual Property Laws Amendment (Productivity Commission Response Part 2 and Other Measures) Bill 2019 clears the Senate and heads to the House of Reps What is in the Bill? While certain proposed changes to...
The Intellectual Property Office of New Zealand (IPONZ) has announced the introduction of excess claims fee, an increase in the examination fee, and increases in application/patent maintenance/renewal fees. A full...
Today the Federal Court ordered an interlocutory injunction against Sandoz, restraining it from selling biosimilar rituximab (Riximyo) in Australia until 11 August 2019. The 4 Roche patents involved in the...
J&J suffered another blow today as a key Remicade® (infliximab) patent was revoked by US Court of Appeals (Federal Circuit). Upholding the USPTO decision on reexamination of US 6,284,471, the Fed Cir held that...
Biosimilar development is not for the faint hearted. The time and costs involved in R&D, clinical, and regulatory are exorbitant, and the patent barriers to launch are unprecedented. From a legal perspective, not...
IP Australia is inviting submissions by 17 November 2017 on the first wave of IP reform initiatives arising from the Government's response to the Productivity Commission Report on 25 August 2017. Life sciences...
Eleven years after the launch of the first biosimilar product in EU, we are now in a position to calibrate our biosimilar market expectations with market experience, rather than extrapolating them using educated...
In a case relating to patents for global blockbuster biologic Humira™ (Adalimumab), the Full Federal Court has drawn a bright line around the limitations of the PTE regime in Australia, excluding from eligibility swiss...
This afternoon, the Australian Government released its response to the report of the Productivity Commission Inquiry into IP released 20 December 2016. In its 25 page response to the 752 page Productivity Commission...
Just over a week ago, the US Federal Circuit provided BPCIA “dance lessons” for reference product sponsors and biosimilar applicants, as it handed down its decision in Amgen v Hospira, the third of the Amgen “trilogy”...
The TGA consultation paper can be found here. The TGA paper outlines the biosimilar naming conventions implemented in EU (INN), Japan (BSn), and the planned US 4 letter biologics suffix, and seeks input on whether...
Subscribe to our Pearce IP Blogs and BioBlast™ to recieve our updates via email.
