On 5 April 2024, Samsung Bioepis announced the commencement of Phase 3 clinical trials for SB27, biosimilar to MSD’s Keytruda® (pembrolizumab) in patients with metastatic non-squamous non-small cell lung cancer (NCT06348199).
Biocad initiated phase 1 clinical trials for its pembrolizumab biosimilar BCD-201 in July 2022. Sandoz anticipates commencing phase 1 clinical trials for its pembrolizumab biosimilar in 2024. Formycon, Xbrane, and Celltrion have each previously announced their development of pembrolizumab biosimilars.
On 5 April 2024, Shanghai Henlius Biotech (SHB) announced that its phase 3 studies confirmed that HLX14 (denosumab) is equivalent in efficacy, safety, tolerability and immunogenicity to Amgen’s Prolia®. HLX14 will be indicated for the treatment of osteoporosis in postmenopausal women at high risk of fracture.
SHB announced the successful completion of its phase 1 clinical trials of HLX14 in January 2024.
In June 2022, SHB announced its licence agreement with Organon under which Organon received exclusive global commercialisation rights to HLX14, excluding China, Hong Kong, Macau and Taiwan.
On 4 April 2024, each of Teva Pharmaceuticals and Fresenius Kabi-owned mAbxience announced a strategic licensing agreement relating to an unnamed biosimilar which is already in development for the treatment of multiple oncology conditions. The deal covers multiple markets, including the Europe and the United States. MAbxience offers its biosimilar development expertise and manufacturing facilities in Spain and Argentina whilst Teva will oversee the regulatory processes and commercialisation.
The Korea Biomedical Review reported that, on 3 April 2024, the Korean Ministry of Food and Drug Safety approved Regeneron’s and Bayer’s Eylea® (aflibercept) 8mg intravitreal injection for the treatment of nAMD and DME.
High Dose Eylea® has previously been approved in multiple countries including the US (August 2023 – nAMD, DME and diabetic retinopathy), the EU (January 2024 – nAMD and DME) and Japan (January 2024 – nAMD and DME).
On 3 April 2024, Australia’s PBAC published the July 2024 Meeting Agenda. On the list of drugs seeking to be PBS reimbursed is Sandoz’s high concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab). Hyrimoz® is currently PBS-listed in a 40mg/0.8mL form and reimbursement is now being sought for 20mg/0.2mL, 40mg/0.4ml and 80mg/0.8ml forms.
Sandoz launched its high concentration formulation of Hyrimoz® in Europe in November 2023 and in the US in July 2023.
Also on the PBAC July Agenda are applications for new PBS-listings of:
- Eisai’s Leqembi® (lecanemab) for the treatment of early Alzheimer’s disease and Pfizer’s multiple myeloma treatment Elrexfio® (elranatamab), which are each yet to be TGA-approved; and
- Sanofi’s Beyfortux® (nirsevimab) for the prevention of respiratory syncytial virus in babies, approved by the TGA in November 2023.
Roche has applied to PBS-list a new indication (retinal vein occlusion) and new PFS form of its Vabysmo® (faricimab).
BMS is seeking to vary the existing listings for nivolumab and ipilimumab, and Takeda is seeking authority script listing for vedolizumab for continuing treatment of chronic pouchitis.
The reimbursement of Novo Nordisk’s PBS listed Ozempic® (semaglutide) (and other GLP-1 analogues) for the treatment of type 2 diabetes mellitus will also be considered.
On 2 April 2024, Hangzhou Jiuyan Gene Engineering announced the acceptance of its Chinese application for JiyoutaiTM, biosimilar to Novo Nordisk’s Ozempic® (semaglutide), for type 2 diabetes. This application is reportedly the first in PRC for a semaglutide biosimilar.
According to Novo’s 2023 annual report, patent protection in China for Ozempic expires in 2026.
On 2 April 2024, Korea Biomedical Review reported Samsung Bioepis’ Korean launch of Epysqli®, biosimilar to AstraZeneca’s Soliris® (eculizumab), with a 30% price reduction. Soliris®, developed by Alexion Pharmaceuticals and marketed by AstraZeneca, is used for the treatment of rare conditions such as paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. The annual cost for treatment with Soliris® is approximately 400 million won per patient.
Samsung Bioepis launched Epysqli® in three European countries on 19 October 2023. Epysqli® was approved by the EMA on 30 May 2023.
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
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.