On 23 February 2024, Samsung Bioepis presented two new study results for ustekinumab SB17 (biosimilar to Janssen’s Stelara®) at the 19th Congress of European Crohn’s and Colitis Organisation (ECCO) in Stockholm, Sweden. The results demonstrate SB17 is highly similar to Stelara® in structural, physicochemical, and biological attributes. On 25 February 2024, CHMP provided a positive recommendation for SB17.
The medicine will be commercialised by Sandoz in the US, Canada, EEA, Switzerland and the UK under an exclusive commercialisation agreement entered in September 2023.
Alvotech and Teva Pharmaceuticals announced that FDA approved SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable high concentration, citrate-free biosimilar to Humira®. SIMLANDI® is the first high concentration adalimumab product to be US approved. It is approved for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, and adult ankylosing spondylitis. AVT02 is already approved in CA, AU, EG, EC and Saudi.
On 23 February 2024, the Australian quoted Eli Lilly’s CEO David Ricks as stating that its Alzheimer’s drug donanemab is expected to receive US approval “any day” with approval elsewhere to follow later this year. This news comes after Phase 3 clinical trial results for donanemab, presented at the Alzheimer’s Association International Conference in July 2023, showed that the drug significantly slowed cognitive and functional decline for amyloid-positive early symptomatic Alzheimer’s disease patients.
On 23 February 2024, Regeneron and Sanofi announced that the FDA has accepted to priority review their Dupixent®’s supplemental biologics license application (sBLA) for a 6th indication of uncontrolled chronic obstructive pulmonary disease (COPD) in adults. The target action date for the FDA decision is 27 June 2024. Priority review was granted following positive results from two phase 3 trials. Notably, if approved, Dupixent® would be the first new treatment for COPD in over a decade and the only biologic for this disease.
AstraZeneca announced the successful acquisition of Gracell Biotechnologies, a global clinical-stage biopharmaceutical company specialising in cell therapies for cancer and autoimmune diseases. Gracell’s portfolio notably includes GC012F a clinical stage chimeric antigen receptor T-cell therapy, which is potential new treatment for multiple myeloma, autoimmune diseases and haematologic malignancies. The total transaction is valued at $1.2B USD. Previously on 12 December 2020, AstraZeneca announced its acquisition of Alexion.
On 22 February 2024, EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Samsung Bioepis’s Pyzchiva® (ustekinumab biosimilar). Pyzchiva® is recommended for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease in adults. Pyzchiva® is intended to be supplied as 45 mg and 90 mg solutions for injection and a 130 mg solution for infusion.
Pyzchiva® will be commercialised by Sandoz pursuant to a deal entered into in September 2023, between Sandoz and Samsung Bioepis for SB17 which covers the US, Canada, EEA, Switzerland and the UK.
On 21 February 2023, Polpharma Biologics announced that PB016 (vedolizumab) demonstrated topline pharmacokinetic (PK) and pharmacodynamic (PD) results in comparison to Entyvio® (vedolizumab). The results came from a double blinded, randomised, single dose study which assessed PB016’s PK/PD and immunogenicity in 120 subjects, and demonstrated that PB016 has comparable PK/PD and immunogenicity to Entyvio®.
Samsung Bioepis announced that it has commenced a Ph 1 clinical trial for SB27, biosimilar to Merck’s Keytruda® (pembrolizumab). The study will compare the pharmacokinetics, efficacy, safety, and immunogenicity of SB27 with EU and US-sourced Keytruda®, in patients with stage II-IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy. This announcement follows the report on 15 November 2023 that Samsung Bioepis had received approval from the Ministry of Food and Drug Safety for a Ph I clinical trial of SB27.
Each of Formycon, Xbrane and Celltrion announced (on 19 September 2022, 13 December 2021 and 14 February 2018 respectively) that they have pembrolizumab biosimilars in development. A pembrolizumab biosimilar (BCD-201) is currently the subject of clinical trials commenced by Biocad in July 2022. Sandoz is expecting to commence pembrolizumab biosimilar clinical trials in 2024
On 21 February 2024, Regeneron announced that the FDA has accepted for priority review its BLA for Linvoseltamab for relapsed / refractory multiple myeloma. The target action date is set for 22 August 2024. Priority review was granted following data from a combined Ph 1 | 2 clinical trial (LINKER-MM1).
Earlier in February 2024, the European Medicines Agency accepted for review the marketing authorisation application of linovoseltamab for the same indication.
On 20 February 2024, BMS announced that FDA has accepted, for priority review, its supplemental new drug application (sNDA) for KRAZATI® (adagrasib) in combination with cetuximab for treating patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer. FDA has assigned 21 June 2024 as the Prescription Drug User Fee Act (PDUFA) goal date.
On 20 February 2024, FDA approved J&J ‘s supplemental biologics license application to use TECVAYLI® (teclistamab) with a reduced dosing frequency for cancer patients. This approval increases dosing flexibility in patients on a weight-based dosing regimen. TECVAYLI® was originally approved by the FDA in October 2022 for the treatment of adult patients with RRMM who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
On 20 February 2024, Sandoz announced that Health Canada approved Jubbonti® (denosumab) biosimilar to Amgen’s Prolia®, for all Prolia® indications. Jubbonti® is the first and only Health Canada-approved denosumab biosimilar for osteoporosis and increasing bone mass.
In February 2023 and May 2023 respectively applications for Sandoz’s denosumab biosimilar were accepted by the FDA and EMA.
In March 2023, Mabwell (Shanghai) Bioscience announced that it received Chinese marketing approval for its Mailishu® (denosumab) and it was reported in December 2023 that Celltrion applied to the FDA for marketing authorisation for its Prolia® biosimilar (CT-P41). Other companies have Prolia® biosimilars under development including Samsung Bioepis, Alvotech, Intas,and Shanghai Henlius Biotech.
Health Canada announced that Celltrion’s Remsima™ SC (SC infliximab) has been approved for maintenance therapy in adults with moderate to severe active ulcerative colitis and Crohn’s disease. Remsima™ SC was previously approved by Health Canada for RA on 28 January 2021.
This follows Celltrion’s success in January 2024 in securing the Norwegian government tender for the supply of Remsima SC until 2026.
On 19 February 2024, AstraZeneca and Daiichi Sankyo announced that FDA has accepted its biologics license application (BLA) for the use of datopotamab deruxtecan in treating adult patients with locally advanced or metastatic non–squamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. FDA has decided the fourth quarter of 2024 as the Prescription Drug User Fee Act date. The application was approved based on the Phase III results of study TROPION-Lung01 which showed that datopotamab deruxtecan significantly improved progression-free survival (PFS) in comparison to docetaxel (the current standard of care).
On 19 February 2024, the Korea Biomedical Review published that Celltrion secured a series of tenders to supply biosimilars in Peru including relating to Herzuma® (trastuzumab biosimilar), Truxima® (rituximab biosimilar) and Yulfyma® (adalimumab). These contracts effectively secure more than 50% of the Peruvian rituximab and trastuzumab markets, and an estimated 20% of the Peruvian adalimumab market.
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.