Pearce IP BioBlast for fortnight ending 14 June 2024

14 June 2024 | AU | Approval Alert: Bayer’s High Dose Eylea® (aflibercept) Approved in Australia

On 14 June 2024, Australia’s Therapeutic Goods Administration (TGA) approved Regeneron’s and Bayer’s Eylea® (aflibercept) 8mg intravitreal injection for 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), Japan (January 2024 – nAMD and DME) and Korea (April 2024 – nAMD and DME).

13 June 2024 | EU | Adalvo’s Liraglutide Pre-Filled Pen Obtains First Generic Approval in Europe

On 13 June 2024, Adalvo announced its liraglutide pre-filled pen has been approved in the EU, making it the first EU approved generic liraglutide.  Originator Novo Nordisk supplies liraglutide as Victoza® in EU, which is indicated for the treatment of type 2 diabetes. Adalvo received approval via the decentralised procedure.

According to Adalvo’s announcement, Victoza achieved over $4.8 billion in global sales in 2023.

This news follows Biocon’s 27 March 2024 announcement of its approval of synthetic liraglutide in the UK.

13 June 2024 | Formycon Commences Ph 1 Clinical Trials for Pembrolizumab Biosimilar

On 13 June 2024, Formycon announced that it has commenced Phase 1 trials for its FYB206, biosimilar to Merck’s (MSD) blockbuster Keytruda® (pembrolizumab), in malignant melanoma.  A parallel Phase 3 trial, yet to commence, will compare the safety and efficacy of FYB206 with Keytruda® in non-small cell lung cancer (NSCLC).  Formycon says it expects the earliest market entry for FYB206 to be in 2029 in the US (after Keytruda’s market exclusivity expiry) and in 2030 in Europe.

Other pembrolizumab biosimilars in clinical trials are Amgen’s ABP 234 (Ph 3 study in non-squamous NSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 study for metastatic non-squamous NSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 and 3 clinical trials commenced in April/May 2024).  In March 2024, Korea Biomedical Review reported that Rophibio entered into an agreement with US biotech Avantor in relation to the development of a pembrolizumab biosimilar.

13 June 2024 | KR | Approval Alert: Celltrion’s Ustekinumab Biosimilar Receives South Korean Approval 

On 13 June 2024, the Korea Herald reported that Celltrion’s Steqeyma (CT-P43), biosimilar to J&J’s Stelara® (ustekinumab), has been approved by the South Korean Ministry of Food and Drug Safety for all indications of Stelara®.  No launch date has been announced.

Celltrion is also seeking approval for Steqeyma in Europe, the United States, and Australia.  The company submitted applications with the EMA in May 2023, the FDA in June 2023, and the TGA in April 2023.

Over the last 9 months, a number of ustekinumab biosimilars have been launched, approved or recommended for approval:

• Amgen’s Wezlana® – approved in US (October 2023) and Australia (January 2024, and  PBS listed in April 2024), launched in Canada (March 2024), and received a positive recommendation from EMA’s CHMP (April 2024);
• Alvotech’s AVTO4 – approved in US (as Selarsdi®, with Teva, April 2024), Europe (as Uzpruvo®, with STADA, January 2024) and Japan (with Fuji Pharma, September 2023), and launched in Canada (as Jamteki®, with JAMP Pharma, March 2024); and
• Samsung Bioepis’ SB17 – approved in Europe and Korea (as Pyzchiva® and Epyztek^TM, respectively, April 2024).  Samsung Bioepis is challenging two of Janssen’s Stelara® (ustekinumab) Australian patents in the Australian Federal Court. The trial is provisionally scheduled for November 2024.

12 June 2024 | Zumutor Biologics Commences First-In-Human Ph 1 Trial of ZM008

On 12 June 2024, Boston-based Zumutor Biologics announced that it has commenced its open-label, first-in-human, multicentre, Ph 1 trial of ZM008 in patients with advanced solid tumours.  The trial (NCT06451497) is evaluating ZM008 alone and in combination with pembrolizumab.  ZM008 is a fully human IgG1 monoclonal antibody against LLT1 and disrupts LLT1’s interaction with CD16 receptor on natural killer cells.

The FDA granted Zumutor’s Investigational New Drug (IND) application for ZM008 on 11 August 2023.

11 June 2024 | US | Ono Completes Acquisition of Deciphera for $2.4 Billion
On 11 June 2024, Japan’s Ono Pharma announced completion of its acquisition of US biopharmaceuticals company Deciphera for approximately $2.4 billion.

Ono plans to leverage Deciphera’s oncology research and development capabilities, as well as its sales presence in Europe and the United States, to accelerate Ono’s global expansion.

11 June 2024 | US | Court Orders Permanent Injunction Against Biocon in US Aflibercept Dispute

On 11 June 2024, Judge Kleeh of the US District Court for the Northern District of West Virginia made a permanent injunction order against Biocon in the dispute brought by Regeneron in relation to patents relating to aflibercept.  The order is currently sealed.

As previously reported, following a December 2023 judgment that Biocon infringed eight claims of Regeneron’s US patent 11,084,864, a temporary restraining order was granted on 17 May 2024, and extended on 30 May 2024, preventing Biocon from launching its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from Regeneron.  The temporary order was made to preserve the status quo until the Court could determine the motion for a permanent injunction.

Preliminary injunction motions remain pending against Celltrion (aBLA for CT-P42 submitted to FDA in June 2023), Formycon (aBLA for FYB203 accepted by FDA in August 2023) and Samsung Bioepis (Opuviz FDA-approved in May 2024) in respect of alleged infringement of US Patent No. 11,084,855 (ophthalmic formulations of a VEGF antagonist). On 7 June 2023, Regeneron filed a preliminary injunction motion (under seal) against Amgen (aBLA for ABP 938 accepted by FDA in October 2023) in relation to the same patent.

11 June 2024 | EU | UK | CH | Alvotech and STADA Expand Partnership to Include Denosumab Biosimilar in EU, UK & Switzerland 

On 11 June 2024, Alvotech announced that it has expanded its current partnership with STADA to include AVT03  (denosumab), biosimilar to Amgen’s Prolia®/Xgeva®.

Under the agreement, STADA will be the sponsor of the Alvotech developed product, with semi-exclusive rights to commercialise AVT03 in Europe, Switzerland and the UK and exclusive rights in certain Central Asian and Middle Eastern countries.

The companies’ November 2019 strategic partnership already covers:

• Hukyndra® (AVT02), a high concentration biosimilar to AbbVie’s Humira® (adalimumab), first launched in Europe in June 2022 and in Switzerland in September 2022; and
• Uzprovo® (AVT04), biosimilar to Janssen’s Stelara® (ustekinumab), EU-approved in January 2024 and expected to launch following the expiry of Stelara’s SPC in July 2024.

Under the June 2024 agreement, STADA’s commercialisation rights to the adalimumab and ustekinumab biosimilars will be extended to Commonwealth of Independent States (CIS).  Alvotech will regain commercial rights from STADA to AVT06, biosimilar to Regeneron’s Eylea (aflibercept), for which positive top-line results were reported in January 2024.

11 June 2024 | US | New Indication Alert: Regeneron’s and Sanofi’s Kevzara® (Sarilumab) FDA-Approved for Polyarticular Juvenile Idiopathic Arthritis

On 11 June 2024, Regeneron announced that the FDA approved its Kevzara® (sarilumab) for active polyarticular juvenile idiopathic arthritis (PJIA).  Kevzara® is jointly developed by Regeneron and Sanofi under a global collaboration agreement.

Kevzara® is approved in 25 countries for moderately to severely active rheumatoid arthritis after a DMARD has been used and in the US for polymyalgia rheumatica in patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.

10 June 2024 | US | FDA Accepts Eisai’s sBLA for Leqembi® (lecanemab-irmb) for IV Maintenance Dosing in Treating Early Alzheimer’s Disease

On 10 June 2024, Eisai and Biogen announced that the FDA has accepted Eisai’s Supplemental Biologics License Application (sBLA) for Leqembi® (lecanemab-irmb) for monthly intravenous maintenance dosing in treating early Alzheimer’s disease.  The target PDUFA action date is 25 January 2025.

Biogen reports that Leqembi® is approved for treating Alzheimer’s disease in patients with mild cognitive impairment or mild dementia in the US, Japan, China, and South Korea, and applications are under review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.

6 June 2024 | EU| CHMP Issues Positive Opinion for New Remsima SC® (Infliximab) Dosing

On 6 June 2024, the Korea Biomedical Review reported that Celltrion has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for an additional dosing regimen and dose increase for RemsimaSC® (infliximab).

The new dosing regimen involves three additional IV doses for CD and UC patients commencing at week 10 of IV dosing.  The dose increase provides for as-needed escalation to 240 mg of RemsimaSC® maintenance therapy in CD patients and escalation in patients who have experienced decreased efficacy following 120mg of RemsimaSC®.

RemsimaSC® has been approved in Europe since 2013.  In February 2024, Celltrion launched RemsimaSC® as Zymfentra® in the US.

31 May – 4 June 2024 | Study Demonstrates Biosimilarity of Fresenius Kabi’s FKS518 (Denosumab) with Amgen’s Prolia

At the American Society of Clinical Oncology (ASCO) conference, held from 31 May to 4 June 2024, Fresenius Kabi presented results of a Phase 3 study comparing its FKS518 with Amgen’s Prolia® (denosumab) in postmenopausal women with osteoporosis.  FKS518 was shown to have therapeutic equivalence to Prolia®, with similar safety profiles.

On 27 May 2024, Fresenius Kabi announced that its BLA for denosumab was accepted for review by the US FDA as biosimilar to Prolia®.