The Korea Biomedical Review reported that Celltrion has submitted an application for marketing authorisation to the FDA for CT-P41, its biosimilar to Amgen’s Prolia® (denosumab) for the treatment of osteoporosis and related diseases. The KBR reported that Celltrion has confirmed CT-P41’s equivalence and similarity in a phase III trial, and is seeking approval as an interchangeable biosimilar.
Samsung announced that has signed a settlement and licence agreement with Johnson & Johnson settling all pending US patent litigation between the companies, with a licence to Samsung to commercialise its Stelara (ustekinumab) biosimilar SB17 in the US from 22 February 2025.
Samsung and J&J subsidiary Janssen previously made reference to a settlement (without reference to the licence date) in their joint motion dated 3 August 2023, to terminate Samsung’s Inter Partes Review (IPR) challenging Janssen’s US patent 10 961 307.
Samsung’s BLA for SB17 is under review with the FDA and if approved will be commercialised in the US by Sandoz.
J&J has also entered into ustekinumab settlements with Celltrion (with a US licence date of 7 March 2025), Fresenius Kabi and Formycon (with a US licence date no later than 15 April 2025), Alvotech and Teva (with US licence date no later than 21 February 2025) and Amgen (with a US licence date no later than 1 January 2025).
Merck announced that the FDA has accepted for priority review its new supplemental Biologics License Application (sBLA) seeking approval for Keytruda® in combination with Seagen/Astellas’ Padcev® (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma. The FDA has set a target action date of 9 May 2024.
Alvotech announced that its pharmacokinetic study of AVT05, its Simponi®/Simponi Aria® (golimumab) biosimilar, met its primary endpoint. The study assessed the pharmacokinetics, safety and tolerability of AVT05 compared to Simponi® in healthy adult subjects.
Bio-Thera Solutions announced that its phase III study of BAT2206 demonstrated it is highly similar to Janssen’s Stelara® (ustekinumab) in patients with moderate to severe plaque psoriasis. Bio-Thera confirmed it will present the results at a future medical meeting or in a publication.
On 16 June 2023, Bio-Thera entered a distribution agreement for BAT2206 in Brazil. In 2021 Bio-Thera entered into a licence agreement with Hikma for the US (with option to add Europe) and with Pharmapark for Russia and other CIS countries.
Samsung Biologics disclosed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that it has taken ₩3T (US$2.3B) in orders in 2023 after it has entered a new confidential sales/supply contract worth ₩588B (~US$457M). The contract partner and contract period will be disclosed after 31 December 2025 for confidentiality reasons.
On 25 October 2023, Samsung Biologics announced its Q3/2023 financial results, demonstrating its highest ever quarterly consolidated revenue of ₩1.034T, marking an 18% increase from Q3 2023.
Daiichi Sankyo announced that it has received approval from Japan’s Ministry of Health, Labour and Welfare for Daichirona® for IV injection as an Omicron XBB.1.5-adapted monovalent mRNA vaccine against COVID-19. Daichirona® is the first Japanese-made mRNA vaccine, and will be distributed in the coming days in Japan.
On 19 October 2023, Daiichi and Merck announced a global development and commercialisation collaboration involving Daiichi’s three deruxtecan antibody-drug conjugate candidates: patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan.
Alvotech reported unaudited financial results for the first nine months of 2023. Results included product revenue of US$29.8 million in 2023 compared to US$11.1 million for the same period in 2022, and R&D expenses of US$152.8 million compared to US$133.1 million in 2022. The 2023 revenue consisted of European and Canadian sales of AVT02, Alvotech’s Humira® (adalimumab) biosimilar.
Alvotech also announced that it has resubmitted its BLA for AVT04 Stelara® (ustekinumab) biosimilar, which the FDA has accepted for review with a BsUFA goal date of 16 April 2024. It also reported highlights including the FDA’s acceptance for review of its resubmitted BLA for AVT02 with a goal date of 24 February 2024, as well as marketing approvals for AVT04 in Canada and Japan, and a positive CHMP opinion in Europe.
Formycon AG and Klinge Biopharma GmbH announced that they have applied to the European Medicines Agency (EMA) for marketing authorisation in the EU for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).
Only a few days before on 24 November 2023, Celltrion announced it also applied for EU approval of its aflibercept biosimilar CT-P43. On 29 August 2023, the FDA accepted Formycon’s BLA for FYB203, its biosimilar to Eylea®.
Sanofi and Regeneron have announced they plan to file a supplemental biologics licence application (sBLA) with the FDA for Dupixent® (dupilumab) to treat chronic obstructive pulmonary disease (COPD) by the end of 2023. This application will be based on two phase III clinical trials.
On 20 October 2023, Sanofi and Regeneron received a complete response letter from the FDA regarding its sBLA for Dupixent® for its use in chronic spontaneous urticaria.
Outlook Therapeutics announced that it had a ‘Type A’ meeting with the FDA in October 2023 to discuss the Complete Response Letter (CRL) it received in August 2023 regarding its Biologics License Application (BLA) for ONS-5010, an ophthalmic formulation of bevacizumab, marketed by Genentech as Avastin®, to treat wet AMD. On 29 September 2023 Outlook Therapeutics requested a Type A meeting with the FDA (an immediately necessary meeting for a drug development program to proceed). The FDA confirmed in the Type A meeting that Outlook can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary endpoint at 2 months.
In the CRL dated 30 August 2023, the FDA acknowledged the Outlook NORSE TWO pivotal trial met their safety and efficacy endpoints, but suggested the BLA could not be approved due to several chemistry, manufacturing and control issues, as well as open observations from pre-approval manufacturing inspections and a lack of substantial evidence.
Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Samsung Bioepis asserting infringement of 37 US aflibercept patents. The heavily redacted Complaint does not disclose any information about Samsung’s abbreviated Biologics Drug Application (aBLA) for SB15, biosimilar to Regeneron’s Eylea® (aflibercept), an intravitreal treatment for age-related macular degeneration and other VEGF-mediated eye conditions. However, the Complaint states on information and belief that between 2 July 2019 and 8 June 2023 Samsung entities imported or directed the importation into the US of 36 shipments of SB15.
Samsung has filed IPR petitions against a number of Regeneron aflibercept patents: US10,464,992 on 18 August 2023, relating to formulations of aflibercept, and method of treatment patents US11,253,572 in April 2023, US10,888,601 in April 2023 and US10,130,681 in January 2023.
On 21 November 2023, the Canadian Federal Court of Appeals dismissed Janssen’s appeal from a decision of the Federal Court upholding Canada’s Office of Submission and Intellectual Property (OSIP) refusal of Janssen’s application to list Canadian Patent 3113837 on the PMNOC register for two supplementary new drug submissions relating to Stelara® (ustekinumab).
The Federal Court decision was handed down in July 2023.
CVS Caremark published its Performance Drug List for January 2024, notably removing Amgen’s Amjevita® (adalimumab), the first Humira® biosimilar launched in the US, and replacing it with Sandoz’s Hyrimoz® (adalimumab-adaz) as the preferred adalimumab product.CVS will remove Regeneron’s Eylea® (aflibercept) and Genentech’s Lucentis® (ranibizumab), preferring either Biogen’s Byooviz® or Coherus’ Cimerli® (both ranibizumab biosimilars). There are currently no FDA-approved aflibercept biosimilars, however on 31 October 2023 the FDA accepted Amgen’s BLA for ABP938, and on 29 August 2023 the FDA accepted Formycon’s BLA for FYB203.
CVS will de-list Sandoz’s Ziextenzo® (pegfilgrastim), biosimilar to Amgen’s Neulasta®, and prefer Amneal Bioscience’s Fylnetra® and Pfizer’s Nyvepria®. CVS will also remove Amgen’s Kanjinti® and Pfizer’s Trazimera®, trastuzumab biosimilars to Genentech’s Herceptin®, preferring Teva’s Herzuma® or Biocon’s Ogivri®.
CEO, Executive Lawyer, Patent & Trade Mark Attorney
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is market leading in the field of pharma/biopharma, biotechnology and animal health.
Underpinning Naomi’s legal work is a deep understanding of pharma/biopharma industries, resulting from 25+ years' experience, including as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm and as the Founding Principal of Pearce IP.
Special Counsel, Lawyer
Kate is an experienced IP and patent lawyer, providing IP leadership for pharmaceutical product development and commercialisation in global markets – from initial scoping through to post-launch.
She has developed and implemented global IP strategies over more than 15 years at multi-national pharmaceutical companies. She is an Australian qualified and registered legal practitioner, and has a Master’s degree in IP Law and a BSc in biochemistry.