Pearce IP BioBlast for w/e 05 July 2024

7 July 2024 | IN | Approval Alert: Zydus Life Sciences’ Biosimilar Nivolumab Approved in India
On 7 July 2024, Medical Dialogues reported that Zydus Life Sciences’ biosimilar nivolumab has received approval from India’s Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), for locally advanced or metastatic non-small cell lung cancer.  The SEC has also conditionally approved Zydus’ biosimilar for all other approved indications of BMS’s Opdivo® (nivolumab) in India, subject to Zydus conducting a Phase IV study for those indications.

In September 2020, NeuClone Pharmaceuticals disclosed that it was working on a nivolumab biosimilar, with the product being developed in partnership with the Serum Institute of India.

4 July 2024 | EU | EC Approves New Remsima SC® (Infliximab) Dosing
On 4 July 2024, Celltrion announced that it received final approval from the European Commission for an additional dosing regimen and dose increase for Remsima SC® (infliximab). The approval comes almost a month after the CHMP issued a positive opinion for the new dosing.

As previously reported, the new dosing regimen involves three additional IV doses for CD and UC patients with Remsima SC administered from week 10.  The dose increase provides for as-needed escalation to 240 mg of Remsima SC® maintenance therapy in CD patients who have experienced decreased efficacy following 120mg of Remsima SC®.

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

3 July 2024 | EU | New Indication Alert: Dupixent (Dupilumab) Approved for COPD in EU
On 3 July 2024, Sanofi and Regeneron announced that the European Medicines Agency (EMA) approved their Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils.  This is the first approval of Dupixent for COPD anywhere in the world, and the sixth approved indication for the drug in the EU.

Dupixent was recommended by the CHMP for COPD on 31 May 2024.  In February 2024, the FDA accepted Dupixent® for priority review for the same indication.  The target action date for the FDA decision was 27 June 2024 but, on 31 May 2024, was revised to 27 September 2024.

3 July 2024 | Novo Nordisk’s Weekly Icodec Injection Nears Approval in India
Novo Nordisk’s weekly injection insulin Icodec is reported as nearing approval in India following a 19 June 2024 recommendation by the Subject Expert Committee under India’s drug controller to permit the import and sale of the drug.

This news follows the approval of Novo Nordisk’s Wegovy® in China for long-term weight management, targeting patients with a BMI of 30kg/m² and at least one weight-related comorbidity. The company also announced last month its plans for a $4.1 billion expansion of its US manufacturing capacity.

2 July 2024 | US | Checkpoint Therapeutics Resubmits BLA to the FDA for Cosibelimab
Checkpoint Therapeutics has announced that it has resubmitted to the FDA its Biologics License Application (BLA) for cosibelimab for metastatic or locally advanced cutaneous squamous cell carcinoma.  The resubmission aims to address “approvability deficiencies” identified in a previous Complete Response Letter (CRL), relating to findings during an inspection of its third-party contract manufacturing organisation. The CRL did not state concerns about the clinical data, safety, or labelling for cosibelimab.

2 July 2023 | US | Fresenius Kabi Launches Subcutaneous Formulation of its Tocilizumab Biosimilar in US
Fresenius Kabi has launched its subcutaneous formulation of Tyenne® (tocilizumab-aazg), biosimilar to Roche’s Actemra® (tocilizumab), in the United States.  This new formulation provides patients with primary immunodeficiency diseases a convenient alternative to intravenous administration.

Both subcutaneous and intravenous forms of Tyenne were FDA approved on 5 March 2024. Fresenius launched the IV formulation of Tyenne in the US in April 2024.  Fresenius Kabi launched Tyenne in Europe as the first to market biosimilar in November 2023 in both IV and SC formulations.

2 July 2024 | US | Samsung Biologics Signs Record-Breaking $1B CMO Contract
According to a corporate disclosure made to the Korean Exchange by Samsung Biologics, the company has entered into its largest contract manufacturing organisation (CMO) deal to date with an unnamed US based pharmaceutical company valued at USD $1.06b. The contract extends until 31 December 2030 and is said to significantly boost Samsung Biologics’ annual order volume, reflecting a 40% increase over the previous year’s total orders.

This follows Samsung Biologics’ contract manufacturing agreement with Kiniksa Pharmaceuticals last month and the announcement, on 7 February 2024 that Samsung Biologics has partnered with Lego Chem Biosciences to develop and manufacture ADCs.

2 July 2024 | US | Positive Topline Results for Alvotech’s Denosumab Biosimilar
Alvotech announced positive topline results from a confirmatory clinical study for AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®. The study, involving 532 postmenopausal women with osteoporosis, met its primary endpoints, demonstrating clinical similarity in efficacy, safety, immunogenicity, and pharmacokinetics (PK) between AVT03 and Prolia®. Positive results from two additional PK studies comparing AVT03 with Prolia® and Xgeva® also showed equivalent safety and tolerability.

Alvotech’s announcement states that it expects to file marketing applications for AVT03 in major global markets later in 2024.

This comes after Alvotech’s announcement last month that it has expanded its current partnership with STADA to include AVT03 for EU, UK and Switzerland.

Denosumab biosimilars have been approved in the US and EU (Sandoz’s Jubbonti® and Wyost®) and in China (Boan Biotech’s Byoubei® and Boluojia® and Mabwell’s Mailishu® and Maiweijian^TM).

2 July 2024 | US | New Approval Alert: FDA Approves Eli Lilly’s Kisunla^TM (donanemab-azbt) for Alzheimer’s Disease
On 2 July 2024, Eli Lilly announced that the US FDA has approved its Kisunla^TM (donanemab-azbt) for early symptomatic Alzheimer’s Disease (patients with mild cognitive impairment or mild dementia stage of disease).  Once-monthly Kisunla is the first amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed.  This is reported to result in lower treatment costs and fewer infusions.

The 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.

1 July 2024 | EU | AZ Imfinzi/Lynparza Combo Recommended for EU Approval
AstraZeneca has announced that Imfinzi® (durvalumab) and Lynparza® (olaparib) combination has been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP) for certain patients with primary advanced or recurrent endometrial cancer.

1 July 2024 | US | Approval Alert: Tanvex’s Filgrastim Biosimilar Approved by the FDA
Tanvex has announced that the FDA has approved its Nypozi® (TX01), biosimilar to Amgen’s Neupogen® (filgrastim). Nypozi® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.

In December 2019, Tanvex and Amgen settled US litigation brought by Amgen in relation to Tanvex’s filgrastim biosimilar.

The first filgrastim biosimilars approved in Europe were Ratiograstim and Tevagrastim in 2009.  Soon after, Hospira’s filgrastim biosimilar was approved in Australia in 2010. Sandoz’s Zarxio was approved in the US in March 2015.  It is interesting to see new biosimilars still being approved over 20 years later.

1 July 2024 | US | Approval Alert: Samsung Bioepis’ Ustekinumab Biosimilar Approved in US
On 1 July 2024, Samsung Bioepis announced that the FDA approved its Pyzchiva® (SB17), biosimilar to Janssen’s Stelara® (ustekinumab) for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis.  The FDA has provisionally determined Pyzchiva® as interchangeable with Stelara®.

Samsung Bioepis is licensed to launch Pyzchiva® in the US in Q2 2025, under a settlement and licence agreement with J&J entered into in November 2023 resolving pending US litigation between the companies

Samsung Bioepis’ SB17 was approved in April 2024 in Europe (as Pyzchiva®) and Korea (as Epyztek^TM).  Pyzchiva® will be commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

A number of ustekinumab biosimilars are currently approved in Europe, including Alvotech and STADA’s Uzpruvo® (January 2024). Amgen’s Wezenla® received a positive CHMP recommendation in April 2024.

1 July 2024 | EU | Celltrion’s Ustekinumab Biosimilar Recommended by EMA’s CHMP
On 1 July 2024, The Korea Herald reported that EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended European marketing authorisation for Steqeyma (CT-P47), biosimilar to Janssen’s Stelara® (ustekinumab), for plaque psoriasis, psoriatic arthritis, and Crohn’s disease. CHMP’s recommendation is a key step in the European Commission’s final approval process, with approval imminently anticipated.

CHMP’s recommendation follows Celltrion’s earlier approval for Steqeyma in Korea on 13 June 2024. Celltrion is also seeking approval for Steqeyma in the United States, and Australia, submitting applications with FDA in June 2023, and TGA in April 2023.

1 July 2024 | EU | Alteogen Subsidiary Submits EU Application for Aflibercept Biosimilar
On 1 July 2024, South Korea’s Alteogen announced that its subsidiary Altos Biologics submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its ALT-L9, biosimilar to Regeneron’s Eylea® (aflibercept).  According to the press release, Altos Biologics expects to receive approval by 2025 and intends to negotiate licence agreements with potential distributors worldwide.

Altos Biologics completed enrolment in its Phase III trials of ALT-L9 in patients with nAMD in February 2023.  The trials reportedly demonstrated therapeutic equivalence between ALT-L9 and Eylea®.

Biocon received marketing approval for its aflibercept biosimilar (Yesafili®) in the UK (November 2023) and the EU (September 2023), while Formycon’s MAA application for FYB203 (aflibercept) was accepted by EMA in December 2023.

1 July 2024 | US | Amneal and Kashiv Partner on Omalizumab Biosimilar in US
On 1 July 2024, Amneal Pharmaceuticals and Kashiv Biosciences announced that they have entered into an exclusive licence agreement for the US in relation to ADL018, biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab).

ADL018 was developed by Kashiv and is currently in a Phase III clinical trial, commenced in October 2023, in patients with chronic idiopathic/spontaneous urticaria.  Kashiv completed a Phase I clinical trial for ADL018 on 30 June 2023.

Amneal and Kashiv have previously partnered including in relation to Fylnetra™ (biosimilar pegfilgrastim), which was approved by the FDA on 27 May 2022.

In October 2023, Alvotech announced that it had entered an exclusive licensing agreement with Kashiv for ADL018 (AVT23) in the EU, UK, Australia, Canada, and New Zealand.

28 June 2024 | New Indication Alert: Positive CHMP Opinion issued for Third Indication of Roche’s Vabysmo® (Faricimab)
Roche has announced that the EMA’s CHMP has issued a positive opinion for extension of the marketing authorisation for Roche’s Vabysmo® (faricimab) to include visual impairment due to macular oedema secondary to retinal vein occlusion.  If approved, faricimab will be the first bispecific antibody treatment available in the EU for RVO.  A final decision of the European Commission is expected soon.

Vabysmo has previously been approved in the US (in October 2023) and Japan (in March 2024) for macular oedema following retinal vein occlusion.  It is approved in 95 countries for nAMD and diabetic macular oedema.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.