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 Brazilian market. 06 April 2021 | US | 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 confirmed that Hadlima® would be PBS...
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 shown equivalent efficacy to Herceptin®,...
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 relation to the blockbuster antidepressant...
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 competitive, resilient and build scale in...
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 investments from Korea's Shinhan, US' Baxter...
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 'evergreening' by preventing pharmaceutical...
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 approved, Abevmy® will be available for the...
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. Additionally, Fresenius Kabi announced it will...
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 commercialisation of Tuznue® (biosimilar...
Boutique specialist firm Pearce IP is delighted to announce that Special Counsel, Kate Legge commenced with Pearce IP this week. Kate is an IP and patent lawyer with more than 20 years’ experience providing IP...
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 “repurposing”. In particular, TGA has sought...
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 officially declared that 11 February would...
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 growth of Avastin (bevacizumab) was...
Under Australian law, patent infringement proceedings may be started in the Australian Federal Court only by a patentee or an exclusive licensee.[1] When it comes to determining the identity of the patentee or...
TGA has invited submissions on its consultation paper released last Thursday designed to facilitate indication "repurposing", a phrase coined by TGA to describe the Australian registration of new indications for known...
29 Jan 21 | EU | The CHMP recommended 13 medicines for approval. Among the recommendations were two bevacizumab biosimilars, Mabxience's Alymsys® and STADA's Oyavas®. 01 Feb 21 | CA | Celltrion announced it has...
25 Jan 21 | Samsung Bioepis announced the opening of its new headquarters in Incheon. The building was complete in December 2020, and will house approximately 1000 new employees, laboratory and office space. 27 Jan 21...
18 Jan 21 | Prestige Biopharma announced it is set for an IPO in early February 2021. The IPO is expected to be worth US $348 million, with the majority of the funds to be reinvested in R&D. 18 Jan 21 | Innovent...
07 Jan 21 | ADQ announced it will acquire Pharmax Pharmaceuticals, as well as investing in a minority stake in Biocon Biologics. 13 Jan 21 | Kamada announced it has entered into agreements with two undisclosed...
On 5 November 2020, the High Court of Australia refused a special leave application by Mylan Health Pty Ltd to appeal the decision of the Full Federal Court (FFC) in which three patents licensed to Mylan covering its...
05 Jan 21 | EU | The Centre for Biosimilars reported a study presented at the 2020 San Antonio Breast Cancer Symposium found strong uptake of Amgen's Kanjinti (biosimilar trastuzumab) in Europe. 08 Jan 21 | A new...
27 Dec 20 | CN | Innovent announced China's NMPA has approved Byvasda® (biosimilar bevacizumab) for the additional indication of adult recurrent glioblastoma. 30 Dec 20 | Alvotech announced it has broken ground...
21 Dec 20 | Celltrion announced Ph III trials of its proposed ustekinumab biosimilar CT-P43 will be completed by the second half of 2022. Celltrion also announced plans to launch the product when the API patents expire...
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