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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.

GSK’s Nucala® (Mepolizumab) Under Review in China for COPD

Feb 20, 2025

On 20 February 2025, GSK announced that China’s National Medical Products Administration (NMPA) has accepted for review a new drug application for the use of Nucala® (mepolizumab) as add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. According to GSK, if approved, Nucala® could be the first approved biologic with monthly dosing for patients with COPD.

Nucala® has been approved in China for a number of indications, including as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) (January 2025), and as add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older (January 2024).

In December 2024, GSK announced that the US FDA accepted for review data to support a new indication for the use of Nucala® as add-on maintenance treatment for patients with COPD with an eosinophilic phenotype.

Approval Alert: CSL’s Garadacimab Approved in Japan

Feb 20, 2025

On 20 February 2025, CSL announced that its Andembry® (garadacimab) has been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) in subcutaneous 200mg injection pens for the prevention of acute attacks of hereditary angioedema (HAE).

This approval makes Japan the fourth jurisdiction to approve Andembry® (previously referred to as CSL312). Australia was the first to approve Andembry® globally in January 2025, closely followed by the UK (January 2025) and the EU (February 2025).

Andembry® is currently under review by the FDA, with CSL’s Biologics Licence Application (BLA) for the drug accepted in December 2023. According to CSL, Andembry® is also under review by regulatory agencies in Switzerland and Canada.

New Indication Alert: Genmab’s Epkinly® (Epcoritamab) Approved in Japan for R/R Follicular Lymphoma

Feb 20, 2025

On 20 February 2025, Genmab announced that Japan’s Ministry of Health, Labour and Welfare has approved Epkinly® (epcoritamab) for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL; Grades 1 to 3A) who have received two or more prior lines of therapy.

Epkinly® (marketed as Tepkinly® in the EU) was co-developed by Genmab and AbbVie, and the companies share commercial responsibilities in the US and Japan.

In January 2025, New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) provisionally approved Epkinly® (epcoritamab) in 4mg/0.8mL concentrate and 48mg/0.8mL solution for injection, indicated for the treatment of adult patients with R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. This followed provisional approval of the same formulation and indications by Australia’s Therapeutic Goods Administration (TGA) in early January 2025.

Health Canada Approves Bayer/Regeneron’s Eylea® HD PFS with

Feb 20, 2025

On 20 February 2025, Bayer announced that Health Canada has approved Eylea® HD (aflibercept injection, 8mg) in a pre-filled syringe with integrated OcuClick™ dosing system for the treatment of nAMD and diabetic macular oedema (DME).

Eylea® 8mg was jointly developed by Bayer and Regeneron. Regeneron holds the exclusive rights to both low (2mg) and high dose Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

High dose Eylea® pre-filled syringe (OcuClick™) has also been approved in Australia (October 2024) and Europe (September 2024).

High dose Eylea® for intravitreal injection is approved for nAMD and DME in the EU (January 2024), Japan (January 2024), the UK (January 2024) and Australia (June 2024). On 10 February 2025, Bayer announced that it submitted a marketing authorisation application to the European Medicines Agency (EMA) for expanded treatment intervals of up to 6 months with Eylea™ 8 mg for nAMD and DME.

Approval Alert: Celltrion’s Denosumab Biosimilars Third to be Approved in Europe

Feb 19, 2025

On 19 February 2025, Celltrion announced that the European Commission has approved Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the same indications as the reference medicines.

Celltrion’s denosumab biosimilars are the third to be approved in Europe, following approval of Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024).

Stoboclo® and Osenvelt® received positive opinions from the EMA’s CHMP in December 2024.

The EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

Celltrion filed an abbreviated Biologics Licence Application for CT-P41 in the US in December 2023. However, in May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab. That litigation was settled in January 2025, allowing Celltrion to launch its denosumab biosimilars in the US from 1 June 2025.

Approval Alert: Henlius’ Biosimilar Bevacizumab Achieves First Overseas Approval in Bolivia

Feb 19, 2025

On 19 February 2025, Shanghai Henlius Biotech announced that its HANBEITAI, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) has received marketing approval from Bolivia’s Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) under the trade name Longiva™.

This is the drug’s first approval outside China (approved December 2021), making it the fourth self-developed product from Shanghai Henlius Biotech to be marketed overseas.

The first bevacizumab biosimilar was approved in the US in September 2017 and in Europe in January 2018.

GSK’s Blenrep® and AbbVie’s Elahere® Under Review in AU; Expanded Indications for 4 More Biologics

Feb 19, 2025

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the month of January. Among the applications for new medicines to be reviewed is GSK’s Blenrep® (belantamab mafodotin) for the treatment of patients with multiple myeloma that has returned or did not respond to treatment.

Meanwhile, AbbVie’s Elahere® (mirvetuximab soravtansine) has been accepted for review for the treatment for adult patients with a specific type of ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based chemotherapy. Elahere® received EU approval for this indication in November 2024.

Applications for new indications of biopharmaceuticals currently under evaluation by the TGA include:

AstraZeneca’s Imfinzi® (durvalumab) for muscle invasive bladder cancer. Imfinzi® is already also under review by the TGA for the treatment of patients with limited-stage small cell lung cancer;
Takeda’s Adcetris® (brentuximab vedotin) for the treatment of adult patients with previously untreated Hodgkin Lymphoma, in combination with other anti-cancer drugs;
Janssen’s Darzalex SC® (daratumumab) for the treatment of patients with newly-diagnosed multiple myeloma who are ineligible for a stem cell transplant, and high-risk smouldering multiple myeloma; and
Janssen’s Tremfya® (guselkumab) for the treatment of children aged 6 years and older with moderate to severe plaque psoriasis who are eligible for systemic (whole-body) therapy or phototherapy (ultraviolet light therapy.

Approval Alert: European Commission Approves Celltrion’s Aflibercept Biosimilar

Feb 18, 2025

On 18 February 2025, Celltrion announced that the European Commission has approved Eydenzelt® (CT-P42), biosimilar to Bayer/Regeneron’s Eylea® (aflibercept), for the treatment of multiple retinal disorders, including nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV). Eydenzelt® received a positive opinion from the CHMP in December 2024.

Eydenzelt® is the fifth aflibercept biosimilar to be approved in the EU, following: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s FYB203/Baiama®/Ahzantive® (January 2025). Amgen’s Pavblu® and Skojoy® received positive recommendations for marketing approval from the CHMP in January 2025, while Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept biosimilars.

Celltrion filed an NDA with the FDA in June 2023 for Eydenzelt® and received Korean approval for the product in May 2024.

Approval Alert: Biocon’s Ustekinumab Biosimilar Approved in Europe

Feb 18, 2025

On 18 February 2025, Biocon Biologics announced that the European Commission has granted marketing authorisation for Yesintek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). Yesintek® is indicated for the treatment of adults and children with plaque psoriasis and treatment of adults with psoriatic arthritis and Crohn’s disease. The marketing authorisation approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on 14 December 2024.

On 29 August 2024, Biocon announced that it signed a patent settlement and licence agreement with Janssen, which enables Biocon to commercialise Bmab 1200/Yesintek® in Europe, the United Kingdom, Canada and Japan. The agreed launch dates for these jurisdictions remain confidential.

There are a number of ustekinumab biosimilars being marketed in the EU, with three launched during 2024, STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024. Previously approved ustekinumab biosimilars in Europe include Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024). Bio-Thera’s MAA for BAT2206 (ustekinumab) was also accepted by the EMA in July 2024.

Yesintek® was approved in the US in early December 2024 for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. In January 2025, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved Biocon’s subcutaneous ustekinumab (Bmab 1200).

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

Merus’ Petosemtamab Granted FDA Breakthrough Therapy Designation for HNSCC in Combination with Pembrolizumab

Feb 18, 2025

On 18 February 2025, Merus announced that the FDA has granted Breakthrough Therapy Designation (BTD) to petosemtamab in combination with pembrolizumab for the first-line treatment of adults with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (r/m HNSCC).

This is the second BTD for petosemtamab following the same designation given in May 2024 for treatment of patients with r/m HNSCC whose disease has progressed following chemotherapy and an anti-PD-1 antibody. Petosemtamab received Fast Track designation for this indication in August 2023.

Approval Alert: Galderma’s Nemolizumab Approved in the UK and Switzerland

Feb 18, 2025

On 18 February 2025, Galderma announced that Nemluvio® (nemolizumab) for subcutaneous administration has been approved in the UK and Switzerland for two indications:

moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents 12 years of age and older with a body weight of at least 30kg, who are candidates for systemic therapy; and
moderate-to-severe prurigo nodularis in adults who are candidates for systemic therapy.

According to Galderma, these are the first approvals from countries within the Access Consortium framework, an international collaborative initiative comprised of regulatory authorities which work together to address shared challenges. Nemluvio® is currently under review in Australia and Singapore, the remaining members of the Access Consortium, with decisions expected later this year.

Just four days earlier, Galderma announced the approval of Nemluvio® in the EU for the same indications. Nemluvio® has also been approved in the US for moderate to severe atopic dermatitis (December 2024) and prurigo nodularis (August 2024).

Regeneron/Sanofi’s Dupixent® sBLA Accepted for Priority Review for Treating Bullous Pemphigoid

Feb 18, 2025

On 18 February 2025, Regeneron and Sanofi announced that the US FDA has accepted their sBLA for priority review of Dupixent® (dupilumab) for the targeted treatment of bullous pemphigoid (BP). The FDA’s decision is expected by 20 June 2025. If approved, Dupixent® will be the first and only targeted medicine to treat BP in the US.

The FDA is also reviewing a Dupixent® sBLA for chronic spontaneous urticaria (CSU), with action due on 18 April 2025.

Despite the appearance of “business as usual”, Regeneron’s litigation against Sanofi in the US District Court for the Southern District of New York remains on foot, in which Regeneron alleges Sanofi violated the terms of their Dupixent® collaboration agreement.

FDA to Review Alvotech/Teva’s BLA for Biosimilar Aflibercept

Feb 18, 2025

On 18 February 2025, Alvotech and Teva announced that the US FDA has accepted for review a Biologics Licence Application (BLA) for Alvotech-developed AVT06, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg). The companies expect that regulatory approval will be obtained in Q4/2025.

Alvotech and Teva’s partnership commenced in August 2020 for the commercialisation of 5 biosimilars in the US and has subsequently expanded. In addition to AVT06, Alvotech is also developing AVT29, biosimilar to Regeneron’s Eylea HD® (aflibercept, 8 mg). Teva also holds commercialisation rights for AVT29 in the US.

There are currently five aflibercept (2 mg) biosimilars approved in the US: Sandoz’s Enzeevu™ (August 2024), Amgen’s Pavblu™ (August 2024), Formycon/Klinge’s Ahzantive®/FYB203 (June 2024), Biocon’s Yesafili™ (May 2024) and Samsung Bioepis’ Opuviz™/SB15 (May 2024). Amgen’s Pavblu® was the first aflibercept biosimilar to be 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.

On 15 August 2024, Alvotech and its European commercialisation partner, Advanz Pharma announced that the European Medicines Agency (EMA) had accepted a Marketing Authorisation Application (MAA) for AVT06, with marketing authorisation expected to be granted in Q3 2025.

Pearce IP BioBlast® for the week ending 14 February 2025

Feb 17, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending the 14 February 2025 are set out below:

Aflibercept

10 February 2025 | EU | Bayer Submits MAA in Europe for High Dose Eylea™ with Expanded Treatment Intervals

On 10 February 2025, Bayer announced that it has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for expanded treatment intervals of up to 6 months… Read more here.

Bevacizumab

12 February 2025 | NZ | NZ’s Pharmac Expands Funding of and Awards “Principal Supply Status” to Celltrion’s Bevacizumab Biosimilar

On 12 February 2025, New Zealand’s Pharmac announced that, from 1 March 2025, it will extend funding of Celltrion’s Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), for… Read more here.

Bimekizumab

12 February 2025 | UCB’s Two-Year Data for Bimzelx® Demonstrates Sustained Disease Control in HS

On 12 February 2025, UCB announced that two-year data from the BE HEARD trials for Bimzelx® (bimekizumab) demonstrated sustained disease control in patients with moderate to severe… Read more here.

Brentuximab vedotin

12 February 2025 | US | New Indication Alert: FDA Approves Pfizer’s Adcetris® (Brentuximab Vedotin) Combination Therapy for LBCL

Denosumab

16 February 2025 | EU | Approval Alert: Samsung Bioepis’ Denosumab Biosimilars Second to be Approved in EU

13 February 2025 | US | Approval Alert: Samsung Bioepis’ Denosumab Biosimilars Second to be Approved in US

On 13 February 2025, the US FDA approved Samsung Bioepis’ Ospomyv™ and Xbryk™ (denosumab-dssb, SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively. The biosimilars… Read more here.

4 February 2025 | US | Cytiva Subsidiary Seeks to Quash Subpoena Issued in Amgen’s US Denosumab Litigation Against Fresenius Kabi

On 4 February 2025, Cytiva subsidiary media supplier HyClone Laboratories filed a motion in the US District Court for the District of Utah, seeking to quash a subpoena issued to it by Amgen in the… Read more here.

Durvalumab, Cemiplimab, Olaparib, Lecanemab

10 February 2025 | GB-SCT | NHS Scotland to Reimburse Durvalumab, Cemiplimab, and Olaparib; Lecanemab Rejected

On 10 February 2025, the Scottish Medicines Consortium (SMC) issued its February 2025 decisions on medicines for reimbursement by NHS Scotland, including accepting three biologics and rejecting… Read more here.

Enfortumab vedotin

10 February 2025 | Pfizer and Astellas Announce Positive Ph 3 Results for Enfortumab Vedotin/Pembrolizumab Combo

On 10 February 2025, Pfizer and Astellas Pharma announced positive results from their Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The trial evaluated the efficacy and safety of… Read more here.

Garadacimab

13 February 2025 | EU | Approval Alert: CSL’s Garadacimab Approved in Europe

On 13 February 2025, CSL announced that the European Commission has approved Andembry® (garadacimab) to prevent attacks of hereditary angioedema (HAE) in adult and adolescent patients… Read more here.

Golimumab

10 February 2025 | US | Bio-Thera and Intas Partner to Commercialise Golimumab Biosimilar in US

On 10 February 2025, Bio-Thera Solutions announced that it has entered an exclusive US commercialisation and licence agreement with Intas Pharmaceuticals for BAT2506 (golimumab)… Read more here.

Insulin aspart

14 February 2025 | US | Approval Alert: FDA Approves Sanofi’s Merilog™/Merilog™ SoloStar as First Rapid Acting Insulin Biosimilars to Novo Nordisk’s Novolog®

On 14 February 2025, the FDA approved Sanofi-Aventis US’s Merilog™ (injection, 10 mL)/Merilog™ SoloStar (injection, 3 mL) (insulin-aspart-szjj), biosimilars to Novo Nordisk’s Novolog® (insulin aspart)… Read more here.

Linvoseltamab

11 February 2025 | US | FDA Accepts Regeneron’s Resubmitted Linvoseltamab BLA

On 11 February 2025, Regeneron announced that the US FDA has accepted for review its resubmitted Biologics Licence Application (BLA) for linvoseltamab. Linvoseltamab, a BCMAxCD3… Read more here.

Nemolizumab

14 February 2025 | EU | Approval Alert: European Commission Approves Galderma’s Nemolizumab

On 14 February 2025, Galderma announced that the European Commission has approved Nemluvio® (nemolizumab) for both moderate to severe atopic dermatitis and prurigo nodularis… Read more here.

Pembrolizumab

11 February 2025 | CA | New Indication Alert: Health Canada Approves Merck/MSD’s Keytruda® (Pembrolizumab) for Resectable NSCLC

On 11 February 2025, Merck (known as MSD outside the US and Canada) announced that Health Canada has approved Keytruda® (pembrolizumab) for the treatment of adults with resectable Stage… Read more here.

Tocilizumab

13 February 2025 | KR | Celltrion’s Biosimilar Tocilizumab SC Formulation Approved in Korea

Ustekinumab

12 February 2025 | CN | Approval Alert: China’s NMPA Approves Qyuns Therapeutics’ Biosimilar Ustekinumab for Crohn’s Disease

11 February 2025 | AU | Approval Alert: Alvotech/Cipla’s Ustekinumab Biosimilar Approved in Australia

On 11 February 2025, the Australian Therapeutic Goods Administration (TGA) approved Alovtech and Cipla’s Uteknix®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in two formulations… Read more here.

Vedolizumab

9 February 2025 | IN | Intas Receives CDSCO Panel Nod for Biosimilar Vedolizumab Ph 1 Study

Medical Dialogues reports that Intas Pharmaceuticals has received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its… 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 Attorney (AU, NZ) & Trade Mark Attorney (AU)

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.

Nathan Kan

Lawyer

Nathan is a lawyer focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

New Indication Alert: Novo Nordisk’s Wegovy® AU-Approved for Heart Disease

Feb 17, 2025

The Australian Financial Review reports that on 17 February 2025, Novo Nordisk confirmed that Australia’s Therapeutic Goods Administration (TGA) approved an indication extension for Wegovy® (semaglutide) as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (MACE) in overweight and obese adults with established cardiovascular disease (CVD) and without established Type 1 or Type 2 diabetes. The indication extension was registered by the TGA on 19 December 2024.

Novo Nordisk obtained US approval for the same indication of Wegovy® in March 2024. In July 2024, the CHMP adopted a positive opinion for an update to the label for Wegovy® in Europe to reflect a risk reduction of MACE in adults with established CVD and either overweight or obesity without diabetes.

Formycon to Terminate Ph 3 Trial and Pursue US-Approval of Pembrolizumab Biosimilar Based on Ph 1/Analytical Data

Feb 17, 2025

On 17 February 2025, Formycon announced that it will be prematurely terminating the “Lotus” Phase 3 trial of FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab). According to Formycon, based on “intensive scientific dialogue” with the US FDA, it has concluded that the Phase 3 study is no longer necessary for the development and US approval of FYB206. Instead, Formycon proposes to rely on data from its ongoing Phase 1 trial (“Dahlia”), combined with “a comprehensive analytical program”.

The Phase 1 trial was commenced in June 2024 and is comparing the pharmacokinetics, safety and tolerability of FYB206 with Keytruda® in malignant melanoma. The Lotus Phase 3 trial was commenced in July 2024 to compare the efficacy and safety of FYB206 with Keytruda® in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC).

In October 2024, Formycon announced that results of a comparative analytical evaluation of FYB206, published in Drugs in R&D, showed FYB206 to be structurally and functionally “highly similar” to Keytruda®.

Other pembrolizumab biosimilars in clinical trials include Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024), Bio-Thera’s BAT3306 (Ph 1/3 in nsNSCLC commenced 25 July 2024), Amgen’s ABP 234 (Ph 3 in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 and 3 commenced in April 2024 (Ph 3)/May 2024 (Ph 1)). In September 2024, Shanghai Henlius Biotech received approval in China for a clinical trial of its pembrolizumab biosimilar, HLX17.

Approval Alert: Samsung Bioepis’ Denosumab Biosimilars Second to be Approved in EU

Feb 16, 2025

On 16 February 2025, Samsung Bioepis announced that the European Commission has approved Obodence™ (60mg pre-filled syringe) and Xbryk™ (120mg vial), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively. The biosimilars are approved for the same indications as the reference medicines.

This announcement came just days after the FDA approval of Samsung Bioepis’ Ospomyv™and Xbryk™(denosumab-dssb) on 13 February 2025.

Obodence™ and Xbryk™ received positive CHMP opinions in November 2024, and are the second set of denosumab biosimilars to be approved in the EU, following Sandoz’s Wyost® and Jubbonti® (approved May 2024).

The European Medicines Agency has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024). The CHMP adopted positive opinions for Celltrion’s Osenvelt®/CT-P41 and Stoboclo®/CT-P41 in December 2024.

Approval Alert: European Commission Approves Galderma’s Nemolizumab

Feb 14, 2025

On 14 February 2025, Galderma announced that the European Commission has approved Nemluvio® (nemolizumab) for both moderate to severe atopic dermatitis and prurigo nodularis.

According to Galderma, Nemluvio® is the first approved mAb specifically targeting IL-31 receptor alpha, inhibiting the signalling of IL-31 (which drives itch and is involved in inflammation and skin barrier dysfunction), and the only approved biologic for atopic dermatitis and prurigo nodularis with 4-week dosing intervals from the start of treatment.

Nemluvio® received a positive opinion from the EMA’s CHMP in December 2024.

Approval Alert: FDA Approves Sanofi’s Merilog™/Merilog™ SoloStar as First Rapid Acting Insulin Biosimilars to Novo Nordisk’s Novolog®

Feb 14, 2025

Merilog™/Merilog™ SoloStar are the first rapid-acting insulin biosimilars to be approved in the US. There were two long-acting insulin biosimilar products (insulin glargine) approved in 2021, Biocon/Mylan’s Semglee® and Eli Lilly’s Rezvoglar® (reference product: Sanofi’s Lantus®).

Celltrion’s Biosimilar Tocilizumab SC Formulation Approved in Korea

Feb 13, 2025

On 13 February 2025, Celltrion announced that Korea’s Ministry of Food and Drug Safety has approved its subcutaneous formulation for Aptozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), for rheumatoid arthritis (RA). In the same announcement, Celltrion also confirmed that its intravenous (IV) Aptozma™ in 80 mg/4ml formulation received approval.

According to Celltrion, this approval completes its Aptozma™ line up in Korea following approval of IV Aptozma™ in 200mg/10ml and 400mg/20ml formulations in December 2024. The December approval marked the first tocilizumab biosimilar approved in Korea.

In January 2025, Aptozma™ became the third tocilizumab biosimilar approved in the US, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

Approval Alert: CSL’s Garadacimab Approved in Europe

Feb 13, 2025

This is the third approval for the anti-FXIIa mAb, following January 2025 approvals by Australia’s Therapeutic Goods Administration (TGA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Andembry® was recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for funding on Australia’s Pharmaceutical Benefits Scheme (PBS) at its November 2024 meeting.

Andembry® is currently under review by the FDA, with CSL’s Biologics Licence Application (BLA) for the drug (previously referred to as CSL312) accepted in December 2023. According to CSL, Andembry® is also under review by regulatory agencies in Japan, Switzerland and Canada.

Approval Alert: Samsung Bioepis’ Denosumab Biosimilars Second to be Approved in US

Feb 13, 2025

Ospomyv™ and Xbryk™ are the second denosumab biosimilars to be approved in the US, following the approval of Sandoz’s Wyost® and Jubbonti® in March 2024.

There are also a number of denosumab biosimilars in the wings, with the FDA having accepted applications for review, including for: Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024). In December 2023, Celltrion filed an abbreviated Biologics Licence Application (aBLA) for its denosumab biosimilar, CT-P41. Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars. That litigation remains pending, as do similar proceedings brought by Amgen against Fresenius Kabi (FKS518/commenced October 2024) and Accord/Intas (INTP23/commenced November 2024). A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025 (or earlier in certain undisclosed circumstances). Amgen also settled its US litigation against Celltrion in January 2025, permitting launch of Celltrion’s yet to be US-approved denosumab biosimilar from 1 June 2025.

Samsung Bioepis received a positive opinion from the European Medicine Agency’s CHMP in November 2024 for its denosumab biosimilars (to be marketed as Obodence™ and Xbryk™ in Europe).

Approval Alert: China’s NMPA Approves Qyuns Therapeutics’ Biosimilar Ustekinumab for Crohn’s Disease

Feb 12, 2025

On 12 February 2025, Qyuns Therapeutics Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has accepted the marketing authorisation application and supplemental application for QX001S, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), for use in Crohn’s disease. The NMPA has previously approved QX001S for the treatment of moderate-to-severe plaque psoriasis in adults (October 2024) and for use in paediatric plaque psoriasis (December 2024).

Qyuns Therapeutics jointly conducted the R&D and clinical trials for QX001S with Zhongmei Huadong, with QX001S obtaining clinical trial approval in 2018, its Phase I clinical trial completing in 2020, and the Phase III clinical study completing in June 2023.

QX001S was the first ustekinumab biosimilar approved in China, followed closely by CSPC Pharmaceutical Group which announced in November 2024 that its biologic licence application for ustekinumab was accepted by the NMPA.

New Indication Alert: FDA Approves Pfizer’s Adcetris® (Brentuximab Vedotin) Combination Therapy for LBCL

Feb 12, 2025

On 12 February 2025, Pfizer announced that the US FDA has approved Adcetris® (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL). Specific indications include treatment for patients with:

diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS);
DLBCL arising from indolent lymphoma; and
high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy.

The approval is based on data from the Phase 3 ECHELON-3 study, which demonstrated that patients with relapsed/refractory DLBCL who were treated with Adcetris® in combination with lenalidomide and rituximab achieved a statistically significant and clinically meaningful improvement in overall survival.