Aflibercept
23 September 2024 | Positive 52-Week, Ph 3 Results for Celltrion’s Aflibercept Biosimilar
On 23 September 2024, Celltrion announced that it presented the 52-week results of its Phase 3 trial of Eydenzelt™ (CT-P42), biosimilar to Regeneron’s Eylea® (aflibercept), at the European Society of Retina Specialists (EURETINA) conference… Read more here.
23 September 2024 | US | US Court Refuses Preliminary Injunction Regarding Amgen’s Aflibercept Biosimilar
On 23 September 2024, the United States District Court for the Northern District of West Virginia denied Regeneron’s motion for a preliminary injunction against Amgen seeking to prevent it from launching Pavblu™… Read more here.
Bimekizumab
23 September 2024 | US | New Indication Alert: FDA Approves Bimzelx® for Three New Indications
On 23 September 2024, UCB announced that its Bimzelx® (bimekizumab-bkzx) has received FDA approval for active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation and active ankylosing spondylitis… Read more here.
Dupilumab
27 September 2024 | US | CN | New Indication Alert: Sanofi and Regeneron’s Dupixent® Approved in US and China for COPD
On 27 September 2024, Sanofi and Regeneron announced that Dupixent® (dupilumab) has been approved in the US as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD)… Read more here.
Isatuximab
20 September 2024 | US | New Indication Alert: FDA Approves Sanofi’s Sarclisa® for Multiple Myeloma
On 20 September 2024, Sanofi announced that the US FDA has approved Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone as a first line treatment option… Read more here.
Lebrikizumab
25 September 2024 | Data Shows Sustained Efficacy of Eli Lilly’s Ebglyss™ (Lebrikizumab) for Atopic Dermatitis
On 25 September 2024, Eli Lilly published three-year data for its atopic dermatitis treatment, Ebglyss™ (lebrikizumab-lbkz). The results, presented at the European Academy of Dermatology and Venereology (EADV)… Read more here.
Pembrolizumab
25 September 2024 | JP | New Indication Alert: MSD’s Keytruda® Approved in Japan for NSCLC and Urothelial Carcinoma
On 25 September 2024, MSD announced that Japan’s Ministry of Health, Labour and Welfare approved its Keytruda® (pembrolizumab) in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy… Read more here.
Talquetamab
27 September 2024 | AU | Latest Australian Approvals Include Janssen’s Talvey® (Talquetamab) Plus Infliximab and Adalimumab Biosimilars
On 27 September 2024, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Ixifi™, biosimilar to Janssen’s Remicade® (infliximab), in 100mg powder for injection vial… Read more here.
Ustekinumab
27 September 2024 | EU | US | Approval Alert: Formycon/Fresenius’ Ustekinumab Biosimilar Approved in US and Europe
On 27 September 2024, Formycon and Fresenius Kabi announced that Otulfi®/FYB202, biosimilar to Janssen’s Stelara® (ustekinumab), has received approval from both the European Commission and the US FDA… Read more here.
26 September 2024 | UK | Janssen Refused Leave to Appeal UK Court Decision Revoking Stelara® (Ustekinumab) UC Patent
In a short decision published on 26 September 2024, Justice Meade of the High Court of Justice of England and Wales has refused Janssen leave to appeal from a decision that the UK counterpart of Janssen’s European Patent… Read more here.
Ustekinumab | Adalimumab
25 September 2024 | Biocon Presents New Data on Ustekinumab and Adalimumab Biosimilars
On 25 September 2024, Biocon Biologics Ltd announced new data on its adalimumab and ustekinumab biosimilars, presented at the 2024 European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam… Read more here.
Vedolizumab
25 September 2024 | Alvotech’s Vedolizumab Biosimilar Enters the Clinic in Ph 3 Trial
On 25 September 2024, Alvotech announced commencement of a Phase 3 clinical trial for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), in moderate to severe ulcerative colitis… Read more here.
Zolbetuximab
20 September 2024 | EU | KR | Approval Alert: Astellas’ Vyloy™ (Zolbetuximab) Approved for Gastric Cancer in Europe and Korea
On 20 September 2024, Astellas Pharma announced that the European Commission has approved Vyloy™ (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy… Read more here.
About Pearce IP
Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries. Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.
In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.
Maliha Hoque
Paralegal
Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®. She is currently completing her Juris Doctor at the University of Sydney. With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’. Maliha is interested in the intersection of law and science, and digital transformation. She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.
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.