Pearce IP BioBlast® for w/e 26 July 2024

26 July 2024 | EU | New Indication Alert: EU Approves AbbVie’s Skyrizi® (Risankizumab) for UC
On 26 July 2024, AbbVie announced European Commission approval of Skyrizi® (risankizumab) for moderate to severe ulcerative colitis (UC).  Skyrizi® was already approved in the EU for plaque psoriasis, psoriatic arthritis and moderate to severe Crohn’s disease.   

The UC indication was approved in the US in June 2024, following AbbVie’s FDA application in August 2023.   

Skyrizi® received Korean approval in November 2023 for moderate to severe active Crohn’s disease.  

26 July 2024 | EU | Positive CHMP Opinions For 6 Biosimilars, Including 3 for Ustekinumab
At its July 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for six biosimilars.   

Three are biosimilars to Janssen’s Stelara® (ustekinumab): Samsung Bioepis’ Eksunbi, Formycon’s Fymskina (FYB202) and Fresenius Kabi’s Otulfi (FYB202).  All are indicated for plaque psoriasis (adult and paediatric), psoriatic arthritis and Crohn’s disease, with Eksunbi and Fymskina additionally indicated for ulcerative colitis.  

These CHMP positive opinions follow earlier EU approvals with Alvotech/Stada’s Uzpruvo® approved in January 2024, Samsung Bioepis’ Pyzchiva® in April 2024, and Amgen’s Wezenla™ in June 2024.  On 1 July 2024, CHMP also recommended marketing authorisation for Celltrion’s Steqeyma® (CT-P47, ustekinumab).  Bio-Thera is behind the race on this molecule, announcing on 24 July 2024 that its MAA for BAT2206 (ustekinumab) was EMA accepted. 

Positive CHMP opinions were also adopted at the July 2024 meeting for Dr Reddy’s Ituxredi™, biosimilar to Genentech/Biogen’s Rituxan® (rituximab), Midas Pharma’s Ranibizumab Midas, biosimilar to Genentech’s Lucentis® (ranibizumab) and Prestige Biopharma’s Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab). 

In addition, CHMP adopted positive opinions for two innovator biologics, extended indications for five and issued a negative opinion for one, as reported here. 

26 July 2024 | EU | CHMP Positive Opinions for 2 New Biologics; Extended Indications Indications for 5 and Negative Opinion for 1
At its July 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Coherus/TMC Pharma’s Loqtorzi® (toripalimab) for nasopharyngeal carcinoma and oesophageal squamous cell carcinoma.  The CHMP also recommended granting marketing authorisation for Astella Pharma’s Vyloy™ (zolbetuximab) for gastric or gastro-oesophageal junction adenocarcinoma.  

Indication extensions were recommended for the following biologics: 

• MSD’s Keytruda® (pembrolizumab), in combination with enfortumab vedotin, for first-line treatment of unresectable or metastatic urothelial carcinoma. 

• Astella Pharma’s Padcev™ (enfortumab vedotin), in combination with pembrolizumab, for first-line treatment of unresectable or metastatic urothelial cancer in adults eligible for platinum-containing chemotherapy. 

• Janssen’s Rybrevant® (amivantamab), in combination with carboplatin and pemetrexed for adults with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI). 

• Boehringer Ingelheim’s Spevigo® (spesolimab), for generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age as monotherapy. 

• Roche’s Tecentriq® (atezolizumab), as monotherapy for first-line treatment of adults with advanced NSCLC who are ineligible for platinum-based therapy. 

The CHMP recommended against granting marketing authorisation for Eisai’s Leqembi® (lecanemab) for Alzheimer’s disease on the basis that the observed effect of Leqembi® on delaying cognitive decline does not counterbalance the risk of serious side effects.  Eisai has indicated it intends to seek review of the decision. 

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, Hong Kong and Israel, and applications are under review in Australia, Brazil, Canada, Great Britain, India, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland. 

Six biosimilars received positive opinions at CHMP’s July 2024 meeting, as reported here. 

26 July 2024 | EU | Novo Nordisk’s Wegovy® EU Label Update for Reduction in Major Adverse Cardiovascular Events
Novo Nordisk A/S announced on 26 July 2024 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a “positive opinion” for an update to the label of Wegovy® (semaglutide 2.4 mg) to reflect a risk reduction of major adverse cardiovascular events in adults with established cardiovascular disease and either overweight or obesity without diabetes.  This update reflects the findings of the SELECT cardiovascular outcomes trial which demonstrated a significant 20% reduction in major adverse cardiovascular events.  Novo Nordisk expects implementation of the label update within approximately one month. 

The update also aligns with the US FDA approved label expansion for Wegovy® in March 2024. 

25 Jul 2024 | Kashiv BioSciences Completes Patient Enrolment in Phase III Biosimilar Omalizumab Trials
On 25 July 2024, Kashiv BioSciences announced completion of patient enrolment in a Phase III trial of ADL018, its biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab).  The study aims to compare ADL018 and Xolair® in terms of efficacy, safety, tolerability, and immunogenicity in patients with chronic idiopathic/spontaneous urticaria (CSU) who remain symptomatic following H1 antagonist treatment.  

Kashiv completed a Ph I clinical trial for ADL018 on 30 June 2023.  On 1 July 2024, Kashiv and Amneal Pharmaceuticals announced they had entered into an exclusive licence agreement for the US in relation to ADL018.  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. 

25 July 2024 | EU | Sandoz/Samsung Bioepis’ Ustekinumab Biosimilar Launched in EU 
On 25 July 2024, Sandoz announced the European launch of Pyzchiva®, biosimilar to Janssen’s Stelara® (ustekinumab) for treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and paediatric plaque psoriasis.  Although Pyzchiva® is not the first approved ustekinumab product in EU (it followed approval of Alvotech/Stada’s Uzpruvo® in January 2024 and announcement of its launch on 22 July 2024), it is the first ustekinumab biosimilar to be available in all reference medicine strengths.  

Pzychiva® was developed by Samsung Bioepis, and was approved in Europe in April 2024.  It is commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis. 

Amgen’s Wezenla™ has also been approved in Europe (June 2024).  The CHMP has recommended marketing authorisation for Celltrion’s Steqeyma (CT-P47, ustekinumab) (1 July 2024) and, at its July meeting, adopted positive opinions for three more ustekinumab biosimilars: Samsung Bioepis’ Eksunbi, Formycon’s Fymskina (FYB202) and Fresenius Kabi’s Otulfi (FYB202).  Bio-Thera is behind the race on this molecule, announcing on 24 July 2024 that its MAA for BAT2206 (ustekinumab) was EMA accepted. 

25 July 2024 | Bio-Thera’s Pembrolizumab Biosimilar Enters the Clinic in Ph I/III Trial
On 25 July 2024, Bio-Thera announced commencement of an integrated Phase I/III trial for its BAT3306, biosimilar to MSD’s Keytruda® (pembrolizumab), in non-squamous, non-small cell lung cancer (nsNSCLC).  The study will compare the pharmacokinetics, efficacy and safety of BAT3306 with Keytruda®. 

Other pembrolizumab biosimilars in clinical trials are Formycon’s FYB206 (Ph I commenced in June 2024 for malignant melanoma; Ph 3 planned for NSCLC), Amgen’s ABP 234 (Ph 3 study in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 study for metastatic nsNSCLC 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.  Xbrane and Celltrion have also each previously announced a joint pembrolizumab biosimilar development. 

25 July 2024 | Sanofi Reports Q2 2024 Dupixent® (Dupilumab) Sales Over €3.3B
On 25 July 2024, Sanofi revealed that its worldwide sales of Dupixent (dupilumab) grew by 29.2% to €3,303 million in the second quarter of 2024.  Sanofi expects the product to generate revenue of about €13 billion for 2024. 

Earlier this month, Dupixent® received European approval as an add-on maintenance treatment for adults with uncontrolled COPD, the first approval of Dupixent for COPD anywhere in the world.  In May 2024, the FDA accepted Sanofi’s and Regeneron’s sBLA for Dupixent® for adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP). 

24 July 2024| US | EU | FDA and EMA Accept Applications for Bio-Thera’s Ustekinumab Biosimilar
On 24 July 2024, Bio-Thera Solutions announced that the FDA BLA and EMA MAA for its BAT2206 have both been accepted.  BAT2206 is the first biosimilar to Janssen’s Stelara® (ustekinumab) developed by a Chinese company to be submitted to the FDA or EMA for approval.  

Bio-Thera is behind the race on this molecule, following three earlier EU approvals with Alvotech/Stada’s Uzpruvo® approved in January 2024, Samsung Bioepis’  Pyzchiva® in April 2024, and Amgen’s Wezenla™ in June 2024. On 1 July 2024, CHMP also recommended marketing authorisation for Celltrion’s Steqeyma (CT-P47, ustekinumab).  

In the US, the FDA has previously approved Samsung Bioepis’ Pyzchiva® (1 July 2024), Alvotech/Teva’s Selarsdi™ (April 2024) and Amgen’s Wezlana® (October 2023).  More approvals and launches are anticipated in the US in light of J&J/Janssen’s ustekinumab settlements with Accord BioPharma (BLA accepted January 2024, US launch date no later than 15 May 2025), Celltrion (application submitted with FDA in June 2023, US launch date of 7 March 2025) and Fresenius Kabi and Formycon (US launch date no later than 15 April 2025). 

In November 2023, Bio-Thera announced that its Phase III study of BAT2206 demonstrated it is highly similar to Stelara® in patients with moderate to severe plaque psoriasis.  

Bio-Thera’s BLA for BAT2206 is also currently under review by the China National Medicinal Product Administration.  

Bio-Thera has previously received approvals for the biosimilars QLETI® (adalimumab) in China (November 2019); TOFIDENCE™/BAT1806 (tocilizumab) in the US (September 2023, with Biogen acquiring all exclusive rights for countries other than China in a deal announced in April 2021), EU (June 2024) and China; and Avzivi®/Pobevcy® (bevacizumab,) in the US (December 2023, marketed by Sandoz) and China.

23 July 2024 | UK | New Indication Alert: Novo Nordisk’s Wegovy® UK Approved for Serious Heart Problems
On 23 July 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) approved a new indication for semaglutide (Wegovy®) to reduce the risk of serious heart problems or strokes in overweight and obese adults.  Already approved for obesity and weight management, semaglutide is now the first weight loss drug prescribed to prevent cardiovascular events in people with established cardiovascular disease and a BMI of 27 kg/m² or higher.  

This approval is based on the SELECT cardiovascular outcomes trial that semaglutide significantly lowers the incidence of major adverse cardiovascular events (MACE) by 20% compared to placebo, as demonstrated in a trial involving over 17,600 participants.  

Wegovy® was recently shown in a University of Oxford study, supported by the NIHR Oxford Health Biomedical Research Centre and the Medical Research Council, to lower dementia risk by 48% compared to MSD’s Januvia® (sitagliptin). 

23 July 2024 | MSD Reports Topline Results in Ph 2b/3 Trial for Clesrovimab (MK-1654)
On 23 July 2024, Merck (known as MSD outside the US and Canada) announced positive topline results from its Phase 2b/3 trial for clesrovimab (MK-1654) in healthy infants.  Clesrovimab, designed to protect infants from respiratory syncytial virus (RSV), met its primary endpoints, including reducing medically attended lower respiratory infections caused by RSV through Day 150 versus placebo.  MSD plans to present detailed results at an upcoming scientific congress and file them with global regulatory authorities. 

22 July 2024 | US | Approval Alert: FDA Approves Samsung Bioepis’ Epysqli™ as Second Soliris Biosimilar
On 22 July 2024, Samsung Bioepis announced FDA approval of Epysqli™ (SB12, eculizumab-aagh), biosimilar to Alexion’s Soliris® (eculizumab), for paroxysmal nocturnal hemoglobinuria (PNH) and atypical haemolytic uremic syndrome (aHUS).   

This is the second eculizumab biosimilar approved by the FDA, following the approval of Amgen’s Bkemv (eculizumab-aeeb) in May 2024. 

Alexion sued Samsung Bioepis in the UPC in March 2024 and the US in January 2024 alleging infringement of eculizumab patents.  In June 2024, the US Court refused Alexion’s application for an emergency injunction, as reported here. 

Samsung Bioepis’ SB12 (Epysqli®) was EU approved in May 2023.  It was launched in Germany, Italy and Spain in 2023 and in Korea in April 2024. 

22 July 2024 | EU | STADA and Alvotech Launch First Approved Ustekinumab Biosimilar in Europe
On 22 July 2024, STADA and Alvotech announced the launch of biosimilar ustekinumab Uzpruvo® in Europe across the majority of European countries.  STADA and Alvotech plan to launch Uzpruvo® in additional European countries in the coming months, following national price approvals.  Uzpruvo® is the first biosimilar to Janssen’s Stelara® (ustekinumab) approved, and to be launched, in Europe.  The launch follows immediately on the expiry of the European molecule patent. 

Uzpruvo® is the second immunology biosimilar brought to market through the strategic partnership between STADA and Alvotech, following the 2022 launch of Hukyndra® (high-concentration, citrate-free adalimumab). 

Two other ustekinumab biosimilars are approved in Europe: Samsung Bioepis’  Pyzchiva® (April 2024) and Amgen’s Wezenla™ (June 2024).  On 1 July 2024, CHMP also recommended marketing authorisation for Celltrion’s Steqeyma (CT-P47, ustekinumab).   

22 July 2024| MX | Approval Alert: Zydus’ Biosimilar Bevacizumab Approved in Mexico
On 22 July 2024, Zydus Lifesciences announced that it has received approval in Mexico to market Bhava™, biosimilar to Genentech’s Avastin® (bevacizumab) for metastatic colorectal cancer, non-squamous non-small cell lung cancer, metastatic breast cancer, glioblastoma, renal cell carcinoma and ovarian cancer.  Bhava™ is Zydus’ first approved biosimilar in Latin America.  Zydus originally launched its biosimilar bevacizumab in India in 2015 (as Bryxta).   

This comes after Sandoz’s Avzivi® (bevacizumab) received a positive opinion from Europe’s CHMP in May 2024 and Dr Reddy’s launched its Versavo® (bevacizumab) in the UK in March 2024, 5 years after its Indian launch and 6 years after first bevacizumab UK biosimilar approval. 

22 July 2024 | US | FDA Seeks Comment on Biosimilar Development Guidance Documents: 23 October Deadline
The US FDA is seeking information and comments to assist it in assessing how best to advance the development of new biosimilars, as part of the Biosimilar User Fee Amendments of 2022.  The deadline for submitting comments is 23 October 2024. 

Specifically, the FDA is seeking input on the following questions: 

1. Which would be more useful for accelerating biosimilar development: guidance documents that focus on a particular product (product-specific guidance), or guidance documents that are cross-cutting for a class of biosimilar products (product class-specific guidance) such as monoclonal antibodies?
2. Should FDA focus on development of guidance documents for biological products (or classes of biological products) for which there are no approved biosimilars? Or would it be useful for FDA to continue to develop guidance on biosimilar development programs even after one or more biosimilar products have been approved for that biological product or class of biological products? 

Instructions for submitting comments electronically or by paper are provided here. 

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.