At the end of 2020, we reported on a Government review of the Australian patent system and its accessibility for small and medium sized enterprises (SMEs). The Patent...
24 May 21 | IN | Zydus Cadila announced it has launched Ujvira (trastuzumab emtansine) in India. Ujvira is an antibody drug conjugate biosimilar and is available in 100mg and...
12 May 21 | Celltrion released its Q1 2020 financial results, reporting that YoY sales of Celltrion biosimilars increased by 23%. Celltrion announced that it is planning to...
11 May | US | Alvotech filed a federal lawsuit against AbbVie in the US District Court of the Eastern District of Virginia, seeking to clear patent barriers relating to its...
On 11 May 2021, Treasurer Josh Frydenberg announced that the 2021-2022 Australian Federal Budget would introduce a Patent Box tax break. This regime is designed to encourage...
IP waivers alone are nowhere near enough to increase COVID-19 vaccine access for developing countries, but US support for such waivers will create enormous pressure on existing...
01 May 21 | Samsung Bioepis announced a new study demonstrating the structural, physicochemical and biological similarity between its SB11 (proposed ranibizumab biosimilar) and...
Date: 5 May 2021Court: Full Court of the Federal Court of AustraliaJudges: Beach, Moshinsky and Thawley JJ Background Australian Patents AU2012304245 and AU2013100458 (Patents),...
In light of the COVID-19 vaccine supply shortages in Australia, it was refreshing to hear NSW Premier Gladys Berejiklian announce yesterday that the NSW Government will establish...
23 April | Boehringer Ingelheim announced results from a Ph III switching study of Cyltezo® (biosimilar adalimumab) with Humira® produced similar clinical outcomes in terms of...
Pearce IP is proud to announce that our team of patent and trademark lawyers and attorneys have once again been listed as Australia's leading practitioners in the World...
As a second wave of COVID-19 ravages India, the rest of the world should be paying close attention to the reported meltdown of its pharmaceutical manufacturing capabilities and...
Date: 27 April 2021Court: Federal Court of AustraliaJudge: Yates J Background In March 2012, Otsuka Pharmaceutical Co., Ltd and Bristol Myer Squibb Company (together Otsuka/BMS)...
15 April 21 | US | The Centre for Biosimilars reported a poster presented at AMCP 2021 shows a New York state Medicaid biosimilar preference initiative was successful in...
Recent decisions of the Australian Federal Court reinforce the need for exclusive patent licences to include all rights to the patent and provide a timely reminder to patentees...
13 April 2021 | Purple Biotech announced it presented further preclinical data supporting the mechanism of action of NT219 at the American Association of Cancer Research 2021...
06 April 2021 | PlantForm announced it has reached a collaborative research and development agreement with Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab for the...
29 March 2021 | Samsung Bioepis announced on 29 March 2021 that it has launched Hadlima®, its 50mg/mL biosimilar adalimumab in Australia and Canada. Australia's PBAC previously...
24 March 2021 | EirGenix announced that its Ph III clinical trial of EG12014 (proposed trastuzumab biosimilar) has met its primary endpoint. EirGenix announced that EG12014 has...
In February 2021, H. Lundbeck A/S (Lundbeck) was granted special leave by the High Court to appeal the 2020 Full Court decision[1] involving the long running litigation in...
Background In October 2020, the Australian Government announced a $1.5 billion investment in a Modern Manufacturing Strategy (MMS) to help Australian manufacturers become more...
15 March 2021 | Alvotech announced it has completed a second round of its US$100 million private placement. In the first round, Alvotech raised US$65 million, including...
Date: 19 March 2021 Court: Federal Court of Australia Judge: Beach J Background Celgene Corporation (Celgene) markets lenalidomide for a number of blood cancers including...
04 Mar 21 | US | The US Senate unanimously passed the Ensuring Innovation Act and the Advancing Education on Biosimilars Act. The Ensuring Innovation Act aims to stop...
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