Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 13 December 2024 are set out below:
Aflibercept
2 December 2024 | US | Update on Challenges to Regeneron’s US Aflibercept Formulation Patent
On 2 December 2024, Formycon filed a petition for inter partes review of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept, such as Eylea®… Read more here.
Aflibercept, Denosumab, Tocilizumab
12 December 2024 | EU | Celltrion’s Aflibercept, Denosumab and Tocilizumab Biosimilars Among Six to Receive Positive CHMP Opinions
Denosumab
12 December 2024 | US | FDA Accepts Hikma/Richter’s Biosimilar Denosumab Application
On 12 December 2024, Gedeon Richter and Hikma Pharmaceuticals announced that FDA has accepted for review Hikma’s BLA for RGB-14 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®… Read more here.
Dupilumab
14 December 2024 | AU | Sanofi Secures Continued PBS Listing of Dupixent®
The Australian Government has reached an agreement with Sanofi and Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) to ensure Dupixent® (dupilumab) remains listed on the… Read more here.
Faricimab
13 December 2024 | EU | Roche’s Vabysmo® (Faricimab) PFS Approved in EU
On 13 December 2024, Roche announced that the European Medicines Agency (EMA) has approved Vabysmo® (faricimab) pre-filled syringe (PFS) (6mg) for treatment of neovascular or ‘wet’ age-related… Read more here.
Garadacimab, Nemolizumab
At its December 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for CSL’s Andembry® (garadacimab)… Read more here.
Liraglutide
12 December 2024 | AU | Cipla Loses Challenge to Extended Term of Novo Nordisk’s AU Liraglutide Formulation Patent
On 14 May 2024, we reported that Cipla had commenced Federal Court proceedings challenging the patent term extension (PTE) to Novo Nordisk’s liraglutide formulation patent (AU2004290862)… Read more here.
Mepolizumab
9 December 2024 | US | FDA Accepts Review for New COPD Indication of GSK’s Nucala®
On 9 December 2024, GSK announced that the US FDA has accepted for review data to support a new indication for the use of Nucala® (mepolizumab) as an add-on maintenance treatment for… Read more here.
Omalizumab
9 December 2024 | CA | Approval Alert: Celltrion’s Omalizumab Biosimilar First Approved in Canada
Pembrolizumab
9 December 2024 | MSD’s Keytruda® Ph 3 Trial in Ovarian Cancer Meets Primary Endpoint
On 9 December 2024, MSD (known as Merck in the US and Canada) announced that its Phase 3 KEYLYNK-0001 trial for Keytruda® (pembrolizumab) plus chemotherapy, followed by maintenance … Read more here.
Semaglutide
12 December 2024 | EU | EMA Adopts Positive Opinion for Novo Nordisk’s Ozempic®
On 12 December 2024, Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic®… Read more here.
Ustekinumab
9 December 2024 | MENA | MS Pharma & Formycon Partner to Commercialise Biosimilar Ustekinumab in MENA
On 9 December 2024, Formycon and MS Pharma announced that they have entered into a licence and supply agreement for commercialisation of Formycon’s FYB202, biosimilar to Janssen’s Stelara® … 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.