Biosimilars Deals 2021 Archives | Page 5 of 8

Celltrion’s Biosimilar Ustekinumab to be Supplied in the US by Costco

Mar 27, 2025

On 27 March 2025, Celltrion announced that its Steqeyma®, biosimilar to J&J’s Stelara® (ustekinumab), has been added to the US Costco Member Prescription Program. Steqeyma® will be available from US Costco Specialty Pharmacies from 1 April 2025 for self-funded employer plans and Costco members who are uninsured and want to pay cash for their Steqeyma® prescription or who have been denied coverage by their insurers. According to Celltrion, the wholesale acquisition cost (WAC) for Steqeyma® will be discounted by 85% compared with the current US WAC list price of Stelara®.

Steqeyma® was launched in the US in March 2025 for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, paediatric plaque psoriasis and paediatric psoriatic arthritis.

In August 2024, Celltrion also announced the addition of adalimumab-aaty, biosimilar to AbbVie’s Humira®, to the Costco Member Prescription Program.

Alvotech/Kashiv/Advanz’s Omalizumab Biosimilar MAA Accepted in UK

Mar 26, 2025

On 26 March 2025, Alvotech, Kashiv Biosciences and Advanz Pharma announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted its application for marketing authorisation (MAA) for AVT23, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).

In February 2023, Alvotech and Advanz Pharma entered into an exclusive agreement in relation to the commercialisation of AVT23, under which Alvotech was responsible for development and manufacture, while Advanz Pharma handles registration and commercialisation. In October 2023, Alvotech entered into an exclusive licensing agreement with Kashiv in relation to AVT23. Under that agreement, Alvotech has an exclusive licence to commercialise AVT23 in the EU, the UK, Australia, Canada, and New Zealand, while Kashiv is responsible for the development and manufacturing of the biosimilar.

Celltrion’s omalizumab biosimilar, Omlyclo® (CT-P39), was the first to be approved in the UK in July 2024. In January 2025, a UK Court denied Celltrion’s application to revoke Genentech/Novartis’ UK patent for an omalizumab formulation (EP (UK) 3 805 248), finding it was valid and infringed by Celltrion.

Bio-Thera and Dr Reddy’s Enter SE Asia Commercialisation Agreement for Golimumab and Ustekinumab Biosimilars

Mar 26, 2025

On 26 March 2025, Bio-Thera Solutions and Dr Reddy’s announced that they have entered exclusive commercialisation and licence agreements for BAT2206 and BAT2506, biosimilars to J&J/Janssen’s Stelara® (ustekinumab) and Simponi® (golimumab), respectively.

Under the agreement, Bio-Thera will be responsible for developing, manufacturing and supplying BAT2206 and BAT2506 and Dr Reddy’s will commercialise the products in certain Southeast Asian countries, including Cambodia, Indonesia, Malaysia, Philippines, Thailand and Vietnam. Dr Reddy’s will also receive the exclusive commercial rights to BAT2206 in Colombia. The SE Asia deal follows agreements that Bio-Thera entered with Intas/Accord in February 2025 and STADA in May 2024 for the commercialisation of golimumab (BAT2506) in the US and Europe, respectively.

In October 2024, Bio-Thera and Gedeon Richter entered into an exclusive commercialisation and licence agreement for BAT2206 (ustekinumab), under which Richter has exclusive rights to commercialise the product in the European Union, the UK, Switzerland and selected other countries. Bio-Thera’s MAA for BAT2206 (ustekinumab) was accepted by the EMA, and its BLA was accepted by the FDA, in July 2024. A marketing authorisation application is also currently under review by China’s National Medicinal Product Administration.

Approval Alert: FDA Approves Denosumab Biosimilars for Fourth Sponsor

Mar 26, 2025

On 26 March 2025, Fresenius Kabi announced that the US FDA approved its Biologics Licence Application (BLA) for Conexxence® and Bomyntra® (denosumab-bhnt), biosimilars to Amgen’s Prolia® and Xgeva® respectively, for all reference indications. Fresenius is the fourth sponsor to have denosumab biosimilars approved in the US.

Under the terms of a settlement between Fresenius Kabi and Amgen, resulting in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen in October 2024, Fresenius Kabi may launch its denosumab biosimilars in the US in “mid-2025”.

Fresenius Kabi has also confirmed that the global settlement permits European launch of its denosumab biosimilars “later in H2 of 2025”, subject to regulatory approvals.

There are three sponsors with denosumab biosimilars already approved in the US: Celltrion’s Stoboclo® and Osenvelt® (March 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024). A number of denosumab biosimilar BLAs are currently under review by the FDA, including for: Alvotech/Dr Reddy’s (March 2025), Amneal/mAbxience (March 2025), Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), and Teva (October 2024). Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

New Indication Alert: Sanofi’s Dupixent® Obtains Japanese Approval for COPD

Mar 25, 2025

On 28 March 2025, Sanofi and Regeneron announced that Japan’s Ministry of Health, Labour and Welfare has granted marketing and manufacturing authorisation for Dupixent® (dupliumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy.

Dupixent® was approved in the US and China, and the UK, as an add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype in September 2024.

In July 2024, 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.

Pearce IP BioBlast® for the week ending 21 March 2025

Mar 25, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 21 March 2025 are set out below:

Certolizumab

20 March 2025 | Alvotech Acquires Xbrane’s Swedish R&D Operations & Biosimilar Peg-Certolizumab

On 20 March 2025, Alvotech announced its acquisition of Xbrane’s Swedish R&D operations, as well as biosimilar candidate XB003 referencing UCB’s Cimzia® (certolizumab pegol). Xbrane will retain … Read more here.

Denosumab

19 March 2025 | KR | Celltrion Launches Biosimilar Denosumab in Korea; Samsung Bioepis Inks Deal with Hanmi Ahead of Korean Denosumab Biosimilar Launch

On 19 March 2025, Korea Biomedical Review (KBR) reported that Daewoong Pharmaceutical has launched Celltrion’s Stoboclo® (CT-P41), biosimilar to Amgen’s Prolia® (denosumab) at a 28%… Read more here.

18 March 2025 | US | FDA Accepts Alvotech/Dr Reddy’s BLA for Biosimilar Denosumab

In a joint press release on 18 March 2025, Alvotech and Dr Reddy’s announced that the US FDA has accepted their Biologic Licence Application (BLA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab)… Read more here.

Guselkumab

20 March 2025 | US | New Indication Alert: J&J’s Guselkumab FDA Approved for Crohn’s Disease

On 20 March 2025, Johnson & Johnson (J&J) announced that the US FDA has approved Tremfya® (guselkumab) for adult patients with moderately to severely active Crohn’s disease. According to… Read more here.

Pembrolizumab

19 March 2025 | US | New Indication Alert: FDA Approves MSD’s Keytruda® Combo for HER2 Positive Gastric or GEJ Adenocarcinoma

On 19 March 2025, the US FDA approved Merck/MSD’s Keytruda® (pembrolizumab) with trastuzumab, fluoropyrimidine- and platinum- containing chemotherapy for the first-line treatment… 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.

EMA Accepts GSK’s Mepolizumab Indication Expansion Application for COPD

Mar 24, 2025

On 24 March 2025, GSK announced that the European Medicines Agency (EMA) has accepted for review its application to expand the use of Nucala® (mepolizumab) as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.

Corresponding applications for the expanded indication have been made to China’s National Medical Products Administration (NMPA) (February 2024) and the US FDA (December 2024).

Bio-Thera is currently developing a mepolizumab biosimilar, BAT2606, which has completed Ph 1 trials according to the company’s pipeline, and is the subject of an exclusive commercialisation deal struck in March 2024 with Costa Rican healthcare product distributor SteinCares for the exclusive marketing rights of the drug across Latin America.

New Indication Alert: J&J’s Guselkumab FDA Approved for Crohn’s Disease

Mar 20, 2025

On 20 March 2025, Johnson & Johnson (J&J) announced that the US FDA has approved Tremfya® (guselkumab) for adult patients with moderately to severely active Crohn’s disease. According to J&J, Tremfya® is the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options.

Tremfya® is approved in the US for a number of indications, including for the treatment of adults with moderately to severely active ulcerative colitis (September 2024) and adults with plaque psoriasis (PsO) (July 2017).

In December 2024, J&J announced its submission to the FDA of two supplemental Biologics Licence Applications (sBLAs) for approval of Tremfya® for the treatment of children 6 years of age and older with moderate-to-severe PsO and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA).

Alvotech Acquires Xbrane’s Swedish R&D Operations & Biosimilar Peg-Certolizumab

Mar 20, 2025

On 20 March 2025, Alvotech announced its acquisition of Xbrane’s Swedish R&D operations, as well as biosimilar candidate XB003 referencing UCB’s Cimzia® (certolizumab pegol). Xbrane will retain some pre-clinical development programs and will continue to operate as a listed company.

According to Alvotech, the deal is worth approximately USD$27M and is expected to close in April 2025, subject to approvals from the relevant authorities and Xbrane’s shareholders.

In August 2024, Xbrane commenced its out-licensing process for XB003 and in October 2024, announced that it received the first non-binding proposals on XB003. In that announcement, Xbrane said that it had successfully scaled up the production process to clinical scale, analytical similarity to the reference product had been demonstrated, and scientific advice from EMA and FDA on the clinical development plan was expected in Q1 2025.

New Indication Alert: FDA Approves MSD’s Keytruda® Combo for HER2 Positive Gastric or GEJ Adenocarcinoma

Mar 19, 2025

On 19 March 2025, the US FDA approved Merck/MSD’s Keytruda® (pembrolizumab) with trastuzumab, fluoropyrimidine- and platinum- containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-postiive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours express PD-L1 (CPS≥1).

The Keytruda® combination first received accelerated approval for the HER2 positive Gastric/GEJ cancer indication in May 2021 based on an interim analysis of the KEYNOTE-811 trial, with the indication subsequently being revised in November 2023 to add a restriction to patients whose tumours express PD-L1 (Combined Positive Scope [CPS] ≥ 1) as determined by an FDA-approved test.

Keytruda® (with trastuzumab and chemotherapy) was approved in Europe for the same indication in August 2023.

Celltrion Launches Biosimilar Denosumab in Korea; Samsung Bioepis Inks Deal with Hanmi Ahead of Korean Denosumab Biosimilar Launch

Mar 19, 2025

On 19 March 2025, Korea Biomedical Review (KBR) reported that Daewoong Pharmaceutical has launched Celltrion’s Stoboclo® (CT-P41), biosimilar to Amgen’s Prolia® (denosumab) at a 28% discount. Celltrion entered into a joint sales agreement with Daewoong in October 2024, under which the two companies jointly promote Celltrion’s denosumab biosimilars in Korea.

KBR also reported on 19 March 2025, that Samsung Bioepis and Hanmi Pharmaceutical have entered into a joint sales agreement for Samsung Bioepis’ SB16, biosimilar to Amgen’s Prolia® (denosumab). Under the agreement, Samsung Bioepis will be responsible for the development and supply of the biosimilar, with both companies managing marketing and sales.

While Samsung Bioepis’ denosumab biosimilars have not yet been approved in Korea, they were approved in February 2025 in the US (Ospomyv™/Xbryk™) and Europe (Obodence™/ Xbryk™). In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars. Those proceedings are ongoing.

Pearce IP BioBlast® for the week ending 14 March 2025

Mar 18, 2025

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

Aflibercept

14 March 2025 | US | US Appeals Court Denies Injunction Against Amgen’s Aflibercept Biosimilar due to Self-Buffering Design-Around

On 14 March 2025, the US Court of Appeals for the Federal Circuit upheld the ruling of the District Court for the Northern District of Virginia refusing Regeneron’s application for a preliminary injunction… Read more here.

Bevacizumab

12 March 2025 | Intas’ Ophthalmic Bevacizumab Biosimilar to Enter Ph 2/3 Trials

On 12 March 2025, Medical Dialogues reported that Intas Pharmaceuticals has received approval from India’s Subject Expert Committee functional under the Central Drug Standard Control Organisation (CDSCO) to… Read more here.

Liraglutide

12 March 2025 | AU | Approval Alert: Cipla’s Generic Liraglutide Second to be Approved in Australia

On 12 March 2025, Australia’s Therapeutic Goods Administration approved three brands of Cipla’s liraglutide, making it the second approved generic to Novo Nordisk’s Saxenda® in Australia… Read more here.

Pegfilgrastim

10 March 2025 | US | Coherus Exits Biosimilar Business with Pegfilgrastim Sale to Accord BioPharma

On 10 March 2025, Coherus BioSciences reported its fourth quarter and full year financial results for 2024, and announced that it will transfer approximately 50 employees to Intas Pharmaceuticals’… Read more here.

Ustekinumab

13 March 2025 | US | Fifth US Biosimilar Ustekinumab Launched by Celltrion

On 13 March 2025, Celltrion announced that Steqeyma® (CT-P43), biosimilar to J&J’s/Janssen’s Stelara® (ustekinumab), is now available in the US for the treatment of psoriatic arthritis, plaque … Read more here.

13 March 2025 | US | Lumicera Announces US Purchase Agreement with Teva Subsidiary for Alvotech’s Biosimilar Ustekinumab

On 13 March 2025, Business Wire reported that Lumicera Health Services has entered into a purchase agreement with Anda, Inc., a Teva subsidiary, for unbranded ustekinumab, biosimilar to … Read more here.