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Biosimilars Deals 2021

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Jazz Pharmaceuticals’ Ziihera® Recommended by US NCCN for Biliary Tract Cancer

Dec 5, 2024

On 5 December 2024, Jazz Pharmaceuticals’ announced that Ziihera® (zanidatamab-hrii) 50 mg/mL for injection for intravenous use has been recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology as a category 2A treatment option for Biliary Tract Cancers.

The news follows accelerated approval of Ziihera® by the FDA for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an FDA-approved test (November 2024).

Approval Alert: BeiGene’s Tevimbra® (Tislelizumab) Approved in New Zealand

Dec 5, 2024

On 5 December 2024, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) approved BeiGene’s Tevimbra® (Tislelizumab) for the following indications:

as monotherapy for the treatment of adult patients with unresectable, recurrent, locally advanced or metastatic OSCC after prior systemic therapy;
as monotherapy for the treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy;
in combination with pemetrexed and platinum containing chemotherapy for first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC, with PD-L1 expression greater than or equal to 50% but no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations; and
in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of patients with locally advanced or metastatic squamous NSCLC.

This news follows EU approval of Tevimbra® in combination with chemotherapy for the first-line treatment of oesophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (November 2024). BeiGene has also sought Australian approval of Tevimbra® for the treatment of recurrent or metastatic nasopharyngeal carcinoma (July 2024).

Approval Alert: Eisai Receives Mexican Approval of Lecanemab® for Early Alzheimer’s Disease

Dec 5, 2024

On 5 December 2024, Eisai announced that it has received approval for Leqembi® (lecanemab) for use in the treatment of Early Alzheimer’s Disease from Mexico’s Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico.

This news follows approval of Leqembi^® in the UK for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease in August 2024. Leqembi® is approved for MCI and Early Alzheimer’s disease in the UK, US, Japan, China, South Korea, Hong Kong and Israel, and the UAE. Earlier announcements made by Eisai note that applications are under review in the EU, Brazil, Canada, India, Russia, Taiwan, Singapore, Saudi Arabia and Switzerland. In October 2024, Australia’s Therapeutic Goods Administration (TGA) rejected Leqembi® following safety and efficacy concerns.

FDA Approves Merus’ Bizengri® (Zenocutuzumab-zbco) as First Therapy for NRG1 Fusion Cancers

Dec 4, 2024

On 4 December 2024, Merus announced that the FDA has approved Bizengri® (zenocutuzumab-zbco) for adults with pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) that is advanced unresectable or metastatic and has an NRG1 gene fusion. According to Merus, this is the first and only approved treatment for this indication.

The accelerated FDA approval was based on overall response rate (ORR) and duration of response (DOR) in the eNRGy trial. Continued approval of the drug may be subject to a confirmatory clinical study.

This follows Merus’ announcement on 2 December 2024 that it has entered a licence agreement granting Partner Therapeutics US commercialisation rights for zenocutuzumab for the treatment of NRG1 fusion positive cancer.

MSD’s Sac-TMT Granted ‘Breakthrough Therapy’ Designation in US

Dec 4, 2024

On 3 December 2024, Merck, known as MSD outside the US and Canada, announced that sacituzumab tirumotecan (sac-TMT) has been granted Breakthrough Therapy designation by the FDA for advanced or metastatic NSCLC with epidermal growth factor receptor mutations whose disease progressed on or after tyrosine kinase inhibitor and platinum-based chemotherapy.

Sac-TMT is an antibody drug conjugate being developed by MSD in collaboration with Kelun Biotech, which has the commercialisation rights to sac-TMT in Mainland China, Hong Kong, Macau and Taiwan. MSD has a number of Phase 3 studies in progress evaluating sac-TMT as monotherapy, and in combination with Keytruda® (pembrolizumab), in solid tumours.

In November 2024, sac-TMT received its first marketing authorisation in China for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior systemic therapies.

Shanghai Henlius’ NDA for Pertuzumab Biosimilar Accepted in China

Dec 4, 2024

On 4 December 2024, Shanghai Henlius Biotech announced that an NDA for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab), has been accepted by China’s Center for Drug Evaluation of the National Medical Products Administration.

The indications include: use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence; and use in combination with trastuzumab and docetaxel for treatment of patients with HER 2-positive, metastatic or unresectable local recurrent breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

The new drug application was based on the data generated by HLX11 in comparison with Roche’s Perjeta® (pertuzumab), which includes analytical studies of similarities and clinical comparison studies. The data demonstrated that HLX11 is highly similar to Perjeta® in terms of quality, safety and efficacy.

This news follows Shanghai Henlius’ announcement of record net profits for the first half of 2024. In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 and HLX11 under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.

FDA Accepts sBLA for Genentech/Roche’s Columvi® Combination Therapy

Dec 4, 2024

On 4 October 2024, Genentech and Roche announced that the US FDA has accepted Roche’s supplemental biologics licence application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant. Genentech expects approval by 20 July 2025.

Columvi® has been previously approved in the US for the treatment of adults with R/R DLBCL or LBCL arising from follicular lymphoma, after two or more lines of systemic therapy.

This news follows the addition of Columvi® to Australia’s Therapeutic Goods Administration list of prescription medicines for evaluation for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma in September 2024.

FDA Grants Fast Track Designation to Corbus Pharmaceuticals’ CRB-701

Dec 3, 2024

On 3 December 2024, Corbus Pharmaceuticals announced that the US FDA has granted Fast Track designation to CRB-701 (SYS6002) for the treatment of relapsed or refractory metastatic cervical cancer. CRB-701 (SYS6002) is an antibody drug conjugate targeting Nectin-4 that contains a site-specific, cleavable linker and a precise drug antibody ratio of 2 using monomethyl auristatin E as the payload.

Pearce IP BioBlast® for the week ending 29 November 2024

Dec 2, 2024

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 29 November 2024 are set out below:

Belantamab mafodotin 

25 November 2024 | US | FDA Accepts BLA for GSK’s Blenrep® Combination Treatment for Multiple Myeloma

On 25 November 2024, GlaxoSmithKline (GSK) announced that the FDA has accepted its BLA for Blenrep® (belantamab mafodotin) in combination with BorDex… Read more here.

Daratumumab 

28 November 2024 | Global | Celltrion Phase 3 Clinical Trials for Daratumumab, Biosimilar To Janssen’s Darzalex®

On 28 November 2024, Celltrion announced the commencement of global phase 3 clinical trials for CT-P44, biosimilar to Janssen’s Darzalex® (daratumumab)… Read more here.

Dupilumab 

18 November 2024 | US | Regeneron Sues Sanofi For Breach of Dupixent® Collaboration Agreement

Regeneron has sued Sanofi, its partner in the commercialisation of the blockbuster eczema drug Dupixent® (dupilumab), in the US District Court for the Southern District of New York… Read more here.

Lecanemab

28 November 2024 | KR | Eisai Korean Launch of Leqembi for Alzheimer’s Disease

On 28 November 2024, each of Eisai and Biogen announced the launch of Leqembi® (lecanemab) in Korea for the treatment of adult patients with mild cognitive impairment … Read more here.

Olaparib

26 November 2024 | IN | New Indication Alert: AstraZeneca Receives Approval to Market Lynparza (Olaparib) in India

On 26 November 2024, The Economic Times reported that AstraZeneca has received approval from India’s Central Drugs Standard Control Organisation (CSDCO) to market Lynparza®… Read more here.

Omalizumab

26 November 2024 | AU | Approval Alert: Celltrion’s Omlyclo® Is Australia’s First Approved Omalizumab Biosimilar

On 26 November 2024, Celltrion’s Omlyclo®, biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab) was approved in Australia. Omlyclo® is the first omalizumab… Read more here.

Semaglutide 

27 November 2024 | CA | New Indication Alert: Novo Nordisk’s Wegovy® Approved in Canada

On 27 November 2024, Novo Nordisk Canada announced Canadian approval of Wegovy® (semaglutide) for the reduction of risk of non-fatal myocardial infarction in adults… Read more here.

Tiselizumab 

27 November 2024 | EU | New Indication Alert: European Commission Approves BeiGene’s Tevimbra® (Tislelizumab) for ESCC and G/GEJ

On 27 November 2024, BeiGene announced that the European Commission approved Tevimbra® (tislelizumab) in combination with chemotherapy for the first-line treatment… Read more here.

Ustekinumab 

26 November 2024 | CN | Acceptance Alert: CSPC Pharmaceutical’s Ustekinumab Biosimilar Accepted by China’s NMPA

On 26 November 2024, CSPC Pharmaceutical Group Limited (CSPC) announced that its biologic license application for ustekinumab (biosimilar to Johnson & Johnson’s Stelara®)… Read more here.

PBAC News 

28 November 2024 | AU | Pfizer’s Infliximab, Sandoz’s Natalizumab & Samsung Bioepis’ Ustekinumab on Australia’s PBAC March 2025 Agenda

On 28 November 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the March 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting… Read more 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.

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.

Imogen Bain

Paralegal

Imogen is a paralegal supporting Pearce IP’s legal and trade mark teams. Imogen prepares patent litigation updates, conducts legal research, and provides paralegal and administrative assistance.

Imogen comes from a background working in hospitality, where she has learnt how to be an effective communicator and work efficiently. Imogen has an interest in the design space, having completed her Certificate III in Design Fundamentals. Her knowledge of the design industry has improved her understanding of the IP realm and has strengthened her passion for IP law. Imogen is a highly disciplined and organised individual who works to assist her colleagues with dedication and optimism.

Approval Alert: Biocon’s Yesintek® Becomes Sixth Ustekinumab Biosimilar Approved in US

Dec 2, 2024

On 2 December 2024, Biocon Biologics announced that the FDA has approved its Yesintek® (ustekinumab-kfce), biosimilar to J&J’s Stelara® (ustekinumab). Yesintek® joins five other previously FDA-approved Stelara® biosimilars: Formycon and Fresenius Kabi’s Otulfi® (September 2024), Alvotech and Teva’s Selarsdi™ (April 2024), Meiji Seika’s Imuldosa™ (October 2024), Samsung Bioepis’s Pyzchiva® (July 2024), and Amgen’s Wezlana® (October 2024).

Biocon can launch Yesintek® in February 2025 as agreed in a settlement deal between Biocon and J&J entered in February 2024.

J&J Submits sBLAs for Tremfya® for PsO and jPsA

Dec 2, 2024

On 2 December 2024, Johnson & Johnson announced its submission of two supplemental Biologics License Applications (sBLAs) to FDA for approval of Tremfya® (guselkumab) for the treatment of children 6 years of age and older with moderate-to-severe plaque psoriasis (PsO) and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA). These submissions come more than seven years after Tremfya® was approved for treating PsO in adults in the US, where it is also approved for PsA and ulcerative colitis in adults.

Tremfya® is approved in Europe and other countries for plaque psoriasis and active psoriatic arthritis.

Update on Challenges to Regeneron’s US Aflibercept Formulation Patent

Dec 2, 2024

On 2 December 2024, Formycon filed a petition for inter partes review of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept, such as Eylea®. The petition closely followed a petition filed by Samsung Bioepis in relation to the same patent on 20 November 2024. Both petitions challenge the 865 patent for obviousness. Formycon has requested joinder of its petition with that of Samsung Bioepis.

Formycon/Klinge’s aflibercept biosimilar, Ahzantive®/FYB203, was approved in the US in June 2024. Samsung Bioepis’ Opuviz™/SB15 received US approval in May 2024. Other aflibercept biosimilars approved in the US are Sandoz’s Enzeevu™ (August 2024), Amgen’s Pavblu™ (August 2024) and Biocon’s Yesafili™ (May 2024). Amgen’s Pavblu® was launched in the US in October 2024 following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen earlier in October 2024.

This patent is hotly contested in the US. The US District Court for the Northern District of West Virginia recently granted preliminary injunctions against Samsung Bioepis (14 June 2024), Formycon (21 June 2024) and Celltrion (June-July 2024), and a permanent injunction against Biocon (11 June 2024), based on findings of infringement of the same patent (Regeneron’s US patent 11,084,865). Samsung Bioepis, Formycon and Celltrion lodged appeals from the preliminary injunction orders (on 14 June 2024, 25 June 2024, and 10 July 2024, respectively). Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024. Those appeals are all pending.

Approval Alert: Intas Pharmaceutical Receives Approval to Manufacture and Market Biosimilar Pertuzumab in India

Dec 1, 2024

India’s Medical Dialogues reports that Intas Pharmaceuticals has received approval from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the anti-cancer drug pertuzumab, biosimilar to Roche’s Perjeta®, for HER2-positive metastatic breast cancer. This approval is subject to Intas conducting Phase IV studies in India and submitting the Phase IV study protocol within three months of the grant of marketing authorisation of the drug.

China Adds Enhertu® to Health Insurance Plan

Nov 29, 2024

On 29 November 2024, Reuters reported that AstraZeneca and Daiichi Sankyo’s Enhertu® (trastazumab deruxtecan), will be added to China’s state-run health insurance scheme. The addition of the drug, projected to be incorporated from early 2025, will aid in reducing the costs associated with the treatment of breast cancer for patients, with expected price cuts of over 50%. Currently, breast cancer is the second most common type of cancer diagnosed in women in China. Of these diagnoses, approximately 20% are HER2-positive cases, which is the primary target of Enhertu®.

This news follows the previous approval of Enhertu® in China for this indication in July 2023.

Pfizer’s Infliximab, Sandoz’s Natalizumab & Samsung Bioepis’ Ustekinumab on Australia’s PBAC March 2025 Agenda

Nov 28, 2024

On 28 November 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the March 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting. This follows the PBAC’s publication of its September 2024 intracycle meeting outcomes, which noted that, to date, it had not received an acceptable proposal for an expanded listing to facilitate broad access to PD-(L)1 inhibitors which includes MSD’s pembrolizumab and BMS’ nivolumab.

For the March 2025 agenda, half of the submissions selected for consideration are for monoclonal antibodies, 17 of which are list for new PBS additions and 6 for amendments.

Four biosimilars will be considered for new listings:

Pfizer’s Ixifi®, biosimilar to Janssen’s Remicade® (infliximab), for severe active rheumatoid arthritis, ankylosing spondylitis, severe psoriatic arthritis, severe chronic plaque psoriasis, severe Crohn disease, complex refractory fistulising Crohn Disease, and moderate to severe ulcerative colitis

Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), for relapsing-remitting multiple sclerosis

Celltrion’s Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab), for uncontrolled severe asthma, uncontrolled severe allergic asthma, and severe chronic spontaneous urticaria

Samsung Bioepis’ Epyztek®, biosimilar to Janssen’s Stelara® (ustekinumab), for severe chronic plaque psoriasis, severe psoriatic arthritis, severe Crohn disease, and complex refractory fistulising Crohn Disease

One biosimilar is being considered for changes to an existing listing: Celltrion’s Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab).

Other applications for PBS listing additions or amendments that the PBAC will consider at its March 2025 meeting include the following:

New listing applications:	Amendment Applications
Janssen’s Rybrevant® (amivantamab) in combination with Lazcluze® (lazertinib) for non-small cell lung cancer	Janssen’s Darzalex® (daratumumab) for multiple myeloma
Sanofi’s Dupixent® (dupilumab) for severe atopic dermatitis and uncontrolled severe asthma	Amgen’s Xgeva® (denosumab) for giant cell tumour of bone and bone metastases
Pfizer’s Elrexfio® (elranatamab) for relapsed or refractory multiple myeloma	MSD’s Keytruda® (pembrolizumab) for cervical cancer
Roche’s Vabysmo® (faricimab) for macular oedema secondary to retinal vein occlusion	Roche’s Perjeta® (pertuzumab) for HER2+ locally advanced, inflammatory or early stage breast cancer
Kyowa Kirin’s Poteligeo® (mogamulizumab) for cutaneous T-cell lymphoma	Alexion’s Ultomiris® (ravulizumab) for generalised myasthenia gravis
Sanofi’s Beyfortus® (nirsevimab) for the prevention of lower respiratory tract disease caused by respiratory syncytial virus
Novartis’s Xolair® (omalizumab) for uncontrolled severe asthma, uncontrolled severe allergic asthma, and severe chronic spontaneous urticaria
Roche’s Polivy® (polatuzumab vedotin) for diffuse large B-cell lymphoma
UCB Australia’s Rystiggo® (rozanolixizumab) for generalised myasthenia gravis
Amgen’s Imdelltra® (tarlatamab) for small cell lung cancer
Amgen’s Tepezza® (teprotumumab) for thyroid eye disease
Dr Reddy’s Zytorvi® (toripalimab) for nasopharyngeal carcinoma
Astellas’s Vyloy® (zolbetuximab) for gastric or gastroesophageal junction cancer

Eisai Korean Launch of Leqembi for Alzheimer’s Disease

Nov 28, 2024

On 28 November 2024, each of Eisai and Biogen announced the launch of Leqembi® (lecanemab) in Korea for the treatment of adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD dementia (early AD). The product was approved by Korea’s Ministry of Food and Drug Safety (MFDS) in May 2024.

Earlier this month, Eisai announced that it had received a positive opinion from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of Leqembi®.

Leqembi® is approved for MCI and Early Alzheimer’s disease in the  UK,  US,  Japan,  China,  South Korea,  Hong Kong and Israel, and  the UAE. Earlier announcements made by Eisai note that applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland.  In October 2024, Australia’s TGA rejected Leqembi® following safety and efficacy concerns.

Celltrion Phase 3 Clinical Trials for Daratumumab, Biosimilar To Janssen’s Darzalex®

Nov 28, 2024

On 28 November 2024, Celltrion announced the commencement of global phase 3 clinical trials for CT-P44, biosimilar to Janssen’s Darzalex® (daratumumab).

This news follows Celltrion’s announcement earlier this month of record high sales for Q3 2024, reaching KRW 2.4 trillion, up 31.2% year on year. Celltrion also revealed this month the preclinical study results of two new antibody-drug conjugate (ADC) candidates – with Celltrion internal codes CT-P70 and CT-P71, designed to target solid cancers.

New Indication Alert: European Commission Approves BeiGene’s Tevimbra® (Tislelizumab) for ESCC and G/GEJ

Nov 27, 2024

On 27 November 2024, BeiGene announced that the European Commission approved Tevimbra® (tislelizumab) in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. Tevimbra® was previously EU approved for unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy and for three NSCLC indications covering both the first- and second-line settings (April 2024).

This news follows recommendation of these new indications by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2024. BeiGine has also sought Australian approval of Tevimbra® for the treatment of recurrent or metastatic nasopharyngeal carcinoma (July 2024).

New Indication Alert: Novo Nordisk’s Wegovy® Approved in Canada

Nov 27, 2024

On 27 November 2024, Novo Nordisk Canada announced Canadian approval of Wegovy® (semaglutide) for the reduction of risk of non-fatal myocardial infarction in adults with established cardiovascular disease. 

Wegovy® was approved in Canada for the treatment of obesity in November 2021. Wegovy® is the first Health Canada-approved treatment supporting both chronic weight management and risk reduction regarding myocardial infarction.

Acceptance Alert: CSPC Pharmaceutical’s Ustekinumab Biosimilar Accepted by China’s NMPA

Nov 26, 2024

On 26 November 2024, CSPC Pharmaceutical Group Limited (CSPC) announced that its biologic license application for ustekinumab (biosimilar to Johnson & Johnson’s Stelara®) was accepted by the People’s Republic of China’s National Medical Products Administration (NMPA).

CSPC’s ustekinumab biosimilar was developed by related company CSPC Megalith Biopharmaceuticals.

Approval Alert: Celltrion’s Omlyclo® Is Australia’s First Approved Omalizumab Biosimilar

Nov 26, 2024

On 26 November 2024, Celltrion’s Omlyclo®, biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab) was approved in Australia. Omlyclo® is the first omalizumab biosimilar approved in Australia.

Omylclo® was approved in Australia for two presentations:

75 mg/0.5 mL solution for injection in a pre-filled syringe with needle guard (427223)

150 mg/ mL solution for injection in a pre-filled syringe with needle guard (427224)

Whilst there are no Australian patent proceedings on foot to date regarding omalizumab, Novartis/Genentech and Celltrion are involved in UPC proceedings regarding alleged infringement of EP3805248 relating to an omalizumab formulation. In September 2024, the Dusseldorf Local Division of the UPC rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion.

Celltrion’s Omlyclo® is approved in  Europe (May 2024), the  UK (July 2024) and  South Korea (June 2024).  Celltrion  submitted an aBLA in the US  for its omalizumab biosimilar in March 2024 and in  Canada in December 2023.

KashivBiosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.

New Indication Alert: AstraZeneca Receives Approval to Market Lynparza (Olaparib) in India

Nov 26, 2024

On 26 November 2024, The Economic Times reported that AstraZeneca has received approval from India’s Central Drugs Standard Control Organisation (CSDCO) to market Lynparza® (olaparib) in India.

The CDSCO granted approval for the use of Lynparza® in combination with durvalumab for the maintenance treatment of advanced or recurrent endometrial cancer in adults whose disease has not progressed on first-line platinum-based chemotherapy. Lynparza® received Indian approval in August 2022 as a monotherapy for adjuvant treatment of patients with high-risk early breast cancer.

This follows European approval of the combination treatment in August 2024. AstraZeneca confirmed in August 2024 that regulatory submissions for Imfinzi® and Lynparza® were (then) under review in Japan and several other countries.

FDA Accepts BLA for GSK’s Blenrep® Combination Treatment for Multiple Myeloma

Nov 25, 2024

On 25 November 2024, GlaxoSmithKline (GSK) announced that the FDA has accepted its BLA for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) or PomDex (pomalidomide plus dexamethasone) for the treatment of patients with multiple myeloma who have received at least one prior line of therapy. Both combination treatments were accepted for review in Japan in September 2024 and the BorDex combination was granted Breakthrough Therapy Designation (BTD) in China in September 2024. BlenRep is approved as a monotherapy in Hong Kong.

This follows GSK’s announcement a week earlier of positive results demonstrating that Blenrep® in combination with BorDex reduced the risk of death when compared with standard of care.

Pearce IP BioBlast® for the week ending 22 November 2024

Nov 25, 2024

Aflibercept

18 November 2024 | EU | Approval Alert: Samsung Bioepis/Biogen’s Aflibercept Biosimilar Approved in EU

On 18 November 2024, Samsung Bioepis and Biogen announced that the European Commission has approved Opuviz™/SB15, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)… … Read more here.

Bimekizumab

20 November 2024 | US | New Indication Alert: FDA Approves UCB’s Bimzelx® (Bimekizumab-bkzx) as First IL-17A/IL-17F Inhibitor for Hidradenitis Suppurativa

On 20 November 2024, UCB announced that Bimzelx® (bimekizumab-bkzx) was approved by the FDA as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa… Read more here.

Denosumab

22 November 2024 | KR | Celltrion Denosumab Biosimilars First to be Approved in Korea

On 22 November 2024, Celltrion announced that the Korean Ministry of Food and Drug Safety has approved its Stoboclo™ (CT-P41, denosumab) and Osenvelt™ (CT-P41, denosumab)… Read more here.

18 November 2024 | US | Amgen Sues Accord and Intas in Fifth US BPCIA Denosumab Patent Suit; Seeks to Consolidate Proceedings

On 13 November 2024, Amgen filed a BPCIA Complaint for Patent Infringement in the US District Court for the Eastern District of North Carolina against Accord Biopharma… Read more here.

Denosumab, Tocilizumab

18 November 2024 | Celltrion Publishes Additional Phase 3 Study Results Supporting Denosumab and Tocilizumab Biosimilars

In April 2024, we reported that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to Amgen’s Prolia® (denosumab), and published those results in late July… Read more here.

Guselkumab

22 November 2024 | US | J&J Seeks FDA Approval for SC Induction Regimen of Tremfya® (Guselkumab) in Ulcerative Colitis

On 22 November 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the FDA seeking approval of a subcutaneous (SC) induction regimen of Tremfya®… Read more here.

Lebrikizumab

19 November 2024 | CA | Canada’s Drug Agency Recommends Against Reimbursement of Ebglyss™ (Lebrikizumab)

On 15 November 2024, Canada’s Drug Agency (CDA-AMC) published its final recommendation for Eli Lilly’s Ebglyss™ (lebrikizumab), recommending against reimbursement of Ebglyss™… Read more here.

Marstacimab

20 November 2024 | EU | Approval Alert: Pfizer’s Hympavzi™ (Marstacimab) Receives EU Approval

On 20 November 2024, Pfizer announced that the European Commission (EC) has approved its Hympavzi™ (marstacimab) for the routine prophylaxis of bleeding episodes in patients… Read more here.

Mirvetuximab soravtansine

18 November 2024 | EU | Approval Alert: AbbVie’s Elahere® (Mirvetuximab Soravtansine) EU-Approved for Platinum-Resistant Ovarian Cancer

On 18 November 2024, AbbVie announced that European Commission (EC) has approved Elahere® (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha… Read more here.

Nivolumab

19 November 2024 | Xbrane and Intas to Jointly Develop Nivolumab Biosimilar

On 19 November 2024, Xbrane and Intas announced they have entered an exclusive, global licensing and co-development agreement in relation to Xbrane´s nivolumab biosimilar candidate… Read more here.

6 November 2024 | IN | India’s SEC Recommends Approval of BMS’ Opdivo® for Unresectable or Metastatic Urothelial Carcinoma

India’s Subject Expert Committee (SEC) has recommended the approval of an additional indication for BMS’ Opdivo® (nivolumab) in combination with cisplatin and gemcitabine… Read more here.

Pembrolizumab

19 November 2024 | MSD’s Positive Phase 3 Results for Subcutaneous Pembrolizumab

On 19 November 2024, MSD (Merck in the US and Canada) announced positive topline results from its Phase 3 trial evaluating subcutaneous (SC) administration of pembrolizumab… Read more here.

Pertuzumab

19 November 2024 | IN | Supreme Court of India Directs Delhi HC to Reconsider Injunction Against Zydus’ Pertuzumab Biosimilar

On 19 November 2024, the Economic Times reported that the Supreme Court of India has directed the Delhi High Court to move quickly on reconsidering an injunction… Read more here.

Rituximab

22 November 2024 | JP | New Indication Alert: Chugai/Zenyaku’s Rituximab Approved in Japan for Chronic ITP in Children

On 22 November 2024, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health… Read more here.

Semaglutide

19 November 2024 | CN | Novo Nordisk Launches Wegovy® in China

On 19 November 2024, Reuters reported that Novo Nordisk has launched Wegovy® (semaglutide) in China. The report states that sales will initially be made without insurance subsidy… Read more here.

Zanidatamab

20 November 2024 | US | Approval Alert: FDA Approves Jazz Pharmaceutical’s Ziihera® (Zanidatamab-hrii) for Biliary Tract Cancer

On 20 November 2024, Jazz Pharmaceuticals announced that the US FDA has granted accelerated approval of Ziihera® (zanidatamab-hrii) for the treatment of adults with previously treated… Read more here.

About Pearce IP

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Chantal Savage

Special Counsel, Lawyer

Imogen Bain

Paralegal

Imogen is a paralegal supporting Pearce IP’s legal and trade mark teams. Imogen prepares patent litigation updates, conducts legal research, and provides paralegal and administrative assistance.