Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending the 24 January 2025 are set out below:
Aflibercept
20 January 2025 | EU | New Approval Alert: Formycon’s Aflibercept Biosimilar Approved in Europe
15 January 2025 | US | Celltrion Challenges Regeneron’s US Aflibercept Formulation Patent in IPR Filing
On 15 January 2025, Celltrion filed a petition for inter partes review (IPR2025-00456) of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept, such as Eylea® … Read more here.
Amivantamab
16 January 2025 | CA | New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC
Bimekizumab
16 January 2025 | US | UCB Launches High Dose Bimekizumab in the US
On 16 January 2025, UCB announced that it has launched in the US a high dose presentation of Bimzelx® (bimekizumab-bkzx) in a single-injection 2 mL prefilled syringe and autoinjector… Read more here.
Daratumumab
22 January 2025 | J&J Reports Q4 2024 Results; Annual Darzalex® Sales Total USD11.7B
On 22 January 2025, Johnson & Johnson (J&J) reported its results for Q4 2024, which saw sales growth of 5.3% to $22.5B. On the same day, Genmab announced that worldwide … Read more here.
Denosumab
24 January 2025 | US | Amgen and Celltrion Settle US Denosumab Litigation
On 24 January 2025, Amgen announced that it has settled its patent infringement litigation against Celltrion in the US District Court for the State of New Jersey … Read more here.
20 January 2025 | US | EU | JP | Celltrion Plans 2025 US/EU/JP Launch of Biosimilar Denosumab at Significant Discount for Osteoporosis Prevention
Faricimab
20 January 2025 | CA | Health Canada Approves Roche’s Vabysmo® PFS
On 20 January 2025, Roche announced that Health Canada has approved its Vabysmo® (faricimab) 6.0 mg single-use pre-filled syringe (PFS) for use in the treatment of nAMD … Read more here.
On 24 January 2025, CSL announced that the Australian Therapeutic Goods Administration (TGA) has approved Andembry® (garadacimab)for routine prevention of recurrent hereditary … Read more here.
Golimumab
27 January 2025 | US | Alvotech/Teva’s BLAs for Biosimilar Golimumab First to be Accepted by FDA
On 27 January 2025, Alvotech and Teva Pharmaceuticals announced that the US FDA has accepted for review their Biologics Licence Applications for AVT05, biosimilar to Johnson & Johnson’s Simponi® … Read more here.
Isatuximab
22 January 2025 | EU | New Indication Alert: Sanofi’s Isatuximab Combination Therapy EU Approved for Multiple Myeloma
Lecanemab
27 January 2025 | US | FDA Approves Eisai/Biogen’s Leqembi® IV Maintenance Dosing for Early Alzheimer’s Disease
Tocilizumab
15 January 2025 | Positive Topline Results for Ph 1 & 3 Studies of Mochida/Richter’s Tocilizumab Biosimilar
Toripalimab
17 January 2025 | AU | Approval Alert: Junshi Biosciences/Dr Reddy’s Tuoyi® (Toripalimab) Approved in Australia
Ustekinumab
23 January 2025 | EU | Celltrion Confirms Launch of Biosimilar Ustekinumab in 5 Major EU Countries
On 23 January 2025, Celltrion confirmed that it has completed the launch of Steqeyma®/CT-P43, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in France, Italy, Spain, the UK, and Germany … Read more here.
16 January 2025 | US | Amgen’s Ustekinumab Biosimilar First to Launch in US; Available Through Nuvaila
On 16 January 2025, AIS Health reported that Amgen has launched Wezlana® (ustekinumab), biosimilar to J&J/Janssen’s Stelara® in the US through Optum Health Solution’s … Read more here.
Company News
22 January 2025 | Samsung Biologics Achieves Record 2024 Sales of KRW 4.54T
On 22 January 2025, Samsung Biologics revealed its Q4 and 2024 annual financial results, reporting full year 2024 consolidated revenue of over 4 trillion won(approx. USD2.78bn), … 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.
Naomi Pearce
CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)
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
Lawyer
Nathan is a lawyer specialising in life sciences, providing legal advice and litigation support across intellectual property and commercial disputes. He is passionate about the intersection of law and science, and during his time with the Science and Technology Law Association at the University of Melbourne, he helped lead events, workshops and publications across STEM fields including life sciences, AI and digital transformation.