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...
Date: 11 May 2021 Forum: Australian Patent Office Delegate: Ranganath Subbarayan Background Mr Arieni was a former colleague of one of the named inventors (Mr Fry) of Innovation...
01 Mar 2021 | EU | Biocon and Viatris announced that the CHMP has adopted a positive opinion recommending the marking authorisation of Abevmy® (biosimilar bevacizumab). If...
23 Feb 2021 | In its Q4 2020 investor presentation, Fresenius Kabi announced it will launch its biosimilar adalimumab in Australia in Q2 2021 and in Brazil in Q3 2021....
13 Feb 2021 | Saudi Arabia's Tabuk Pharmaceuticals announced it has reached an exclusive licensing and distribution agreement with Korea's Prestige Biopharma for the...
Date: 16 February 2021Forum: Australian Patent OfficeDelegate: Kevin Restrick Background Under Australian law, business methods are not patent eligible because they are not...
As discussed in Part 1 of this blog series, TGA has invited submissions by 23 March 2021 on its consultation paper released last Thursday designed to facilitate indication...
In honour of UN International Day of Women and Girls in Science Last Thursday was the International Day of Women and Girls in Science, marking 6 years since the United Nations...
04 Feb 2021 | Roche reported a huge erosion of its year on year CER growth in key areas, attributing this decline to COVID-19 impacts and biosimilars. Roche reported the YoY CER...
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