Aflibercept
18 November 2024 | EU | Approval Alert: Samsung Bioepis/Biogen’s Aflibercept Biosimilar Approved in EU
On 18 November 2024, Samsung Bioepis and Biogen announced that the European Commission has approved Opuviz™/SB15, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)… … Read more here.
Bimekizumab
20 November 2024 | US | New Indication Alert: FDA Approves UCB’s Bimzelx® (Bimekizumab-bkzx) as First IL-17A/IL-17F Inhibitor for Hidradenitis Suppurativa
On 20 November 2024, UCB announced that Bimzelx® (bimekizumab-bkzx) was approved by the FDA as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa… Read more here.
Denosumab
22 November 2024 | KR | Celltrion Denosumab Biosimilars First to be Approved in Korea
On 22 November 2024, Celltrion announced that the Korean Ministry of Food and Drug Safety has approved its Stoboclo™ (CT-P41, denosumab) and Osenvelt™ (CT-P41, denosumab)… Read more here.
18 November 2024 | US | Amgen Sues Accord and Intas in Fifth US BPCIA Denosumab Patent Suit; Seeks to Consolidate Proceedings
On 13 November 2024, Amgen filed a BPCIA Complaint for Patent Infringement in the US District Court for the Eastern District of North Carolina against Accord Biopharma… Read more here.
Denosumab, Tocilizumab
18 November 2024 | Celltrion Publishes Additional Phase 3 Study Results Supporting Denosumab and Tocilizumab Biosimilars
In April 2024, we reported that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to Amgen’s Prolia® (denosumab), and published those results in late July… Read more here.
Guselkumab
22 November 2024 | US | J&J Seeks FDA Approval for SC Induction Regimen of Tremfya® (Guselkumab) in Ulcerative Colitis
On 22 November 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the FDA seeking approval of a subcutaneous (SC) induction regimen of Tremfya®… Read more here.
Lebrikizumab
19 November 2024 | CA | Canada’s Drug Agency Recommends Against Reimbursement of Ebglyss™ (Lebrikizumab)
On 15 November 2024, Canada’s Drug Agency (CDA-AMC) published its final recommendation for Eli Lilly’s Ebglyss™ (lebrikizumab), recommending against reimbursement of Ebglyss™… Read more here.
Marstacimab
20 November 2024 | EU | Approval Alert: Pfizer’s Hympavzi™ (Marstacimab) Receives EU Approval
On 20 November 2024, Pfizer announced that the European Commission (EC) has approved its Hympavzi™ (marstacimab) for the routine prophylaxis of bleeding episodes in patients… Read more here.
Mirvetuximab soravtansine
18 November 2024 | EU | Approval Alert: AbbVie’s Elahere® (Mirvetuximab Soravtansine) EU-Approved for Platinum-Resistant Ovarian Cancer
On 18 November 2024, AbbVie announced that European Commission (EC) has approved Elahere® (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha… Read more here.
Nivolumab
19 November 2024 | Xbrane and Intas to Jointly Develop Nivolumab Biosimilar
On 19 November 2024, Xbrane and Intas announced they have entered an exclusive, global licensing and co-development agreement in relation to Xbrane´s nivolumab biosimilar candidate… Read more here.
6 November 2024 | IN | India’s SEC Recommends Approval of BMS’ Opdivo® for Unresectable or Metastatic Urothelial Carcinoma
India’s Subject Expert Committee (SEC) has recommended the approval of an additional indication for BMS’ Opdivo® (nivolumab) in combination with cisplatin and gemcitabine… Read more here.
Pembrolizumab
19 November 2024 | MSD’s Positive Phase 3 Results for Subcutaneous Pembrolizumab
On 19 November 2024, MSD (Merck in the US and Canada) announced positive topline results from its Phase 3 trial evaluating subcutaneous (SC) administration of pembrolizumab… Read more here.
Pertuzumab
19 November 2024 | IN | Supreme Court of India Directs Delhi HC to Reconsider Injunction Against Zydus’ Pertuzumab Biosimilar
On 19 November 2024, the Economic Times reported that the Supreme Court of India has directed the Delhi High Court to move quickly on reconsidering an injunction… Read more here.
Rituximab
22 November 2024 | JP | New Indication Alert: Chugai/Zenyaku’s Rituximab Approved in Japan for Chronic ITP in Children
On 22 November 2024, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health… Read more here.
Semaglutide
19 November 2024 | CN | Novo Nordisk Launches Wegovy® in China
On 19 November 2024, Reuters reported that Novo Nordisk has launched Wegovy® (semaglutide) in China. The report states that sales will initially be made without insurance subsidy… Read more here.
Zanidatamab
20 November 2024 | US | Approval Alert: FDA Approves Jazz Pharmaceutical’s Ziihera® (Zanidatamab-hrii) for Biliary Tract Cancer
On 20 November 2024, Jazz Pharmaceuticals announced that the US FDA has granted accelerated approval of Ziihera® (zanidatamab-hrii) for the treatment of adults with previously treated… Read more here.
About Pearce IP
Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.
Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.
Naomi Pearce
CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.
Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.
Chantal Savage
Special Counsel, Lawyer
Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.
With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.
Nathan Kan
Graduate (Law)
Nathan is a Graduate (Law) focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.
Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.