Biosimilars Deals 2021 Archives | Page 7 of 8

FDA Accepts Alvotech/Dr Reddy’s BLA for Biosimilar Denosumab

Mar 18, 2025

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).

According to the companies, AVT03 will be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution, as well as a 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial.

In May 2024, Dr Reddy’s and Alvotech entered into a licence and supply agreement for the commercialisation of AVT03, under which Alvotech develops and manufactures the product and Dr Reddy’s will commercialise it exclusively in the US, and semi-exclusively in the EU and UK.

There are three 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).

Over the past year, the FDA has accepted a number of denosumab biosimilar BLAs for review, including for: Amneal/mAbxience (March 2025), Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024). Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

MSD’s Keytruda® Under Review and Approved for Additional Indications in Australia; Expanded Indications for BMS’ Opdivo®, Astellas’ Padcev®, Sanofi’s Dupixent® and AZ’s Imfinzi®

Mar 14, 2025

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for February 2025. Among the applications to be reviewed is a new indication for MSD’s Keytruda® (pembrolizumab) for patients with head and neck squamous cell carcinoma (HNSCC) as a preliminary treatment prior to surgery or as a treatment in combination with radiotherapy followed by Keytruda® alone.

The TGA has also updated its online list of prescription medicine registrations, with new registrations for the following expanded indications:

MSD’s Keytruda® in combination with chemoradiotherapy for treatment of patients with high-risk locally advanced cervical cancer (FIGO 2014 Stage IB1-IIB and node-positive, or Stage III-IVA) (3 March 2025) and in combination with Astellas Pharma’s Padcev® (enfortumab vedotin) for first-line treatment of adults with locally advanced or metastatic urothelial carcinoma (24 February 2025)
AstraZeneca’s Imfinzi® (durvalumab) as monotherapy for the treatment of adults with limited stage small cell lung cancer whose disease has not progressed following chemoradiation therapy (27 February 2025);
Sanofi’s Dupixent® (dupilumab) for chronic obstructive pulmonary disease (25 February 2025);
Astellas’ Padcev® (enfortumab vedotin) as monotherapy for treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed dealth-ligand-1 inhibitor (17 February 2025); and
Bristol-Myers Squibb’s Opdivo® (nivolumab), in combination with chemotherapy, for the neoadjuvant treatment of adults with resectable non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, followed by Opdivo® as a single agent in the adjuvant setting after surgical resection (6 February 2025).

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

Mar 14, 2025

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 preventing launch of Amgen’s Pavblu®/APB 938 (aflibercept), biosimilar to Regeneron’s Eylea®.

The Appeals Court agreed with the District Court’s September 2024 ruling that Pavblu® did not infringe the asserted claims of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept. An application to the US Appeals Court by Regeneron for an injunction preventing Amgen from launching Pavblu® pending the substantive appeal had also been rejected in October 2024. Amgen launched Pavblu® in the US immediately following the October 2024 decision.

The Appeals Court determined that the relevant claims of the US 865 patent required an aflibercept formulation that included a separate buffer component, but Amgen’s formulation did not contain any such separate buffer. Instead, the evidence was that “Amgen had discovered a way to prepare and formulate” aflibercept in a manner that eliminates the need for a separate buffer as the aflibercept itself provides sufficient buffering capacity to stabilise the formulation.

The litigation against Amgen is part of consolidated, multi-district BPCIA litigation brought by Regeneron regarding aflibercept biosimilars against each of Samsung Bioepis (2 actions; Opuviz™/SB15 approved May 2024), Biocon (Yesafili™ approved May 2024), Formycon (Ahzantive®/FYB203 approved June 2024), Celltrion (2 actions, aBLA for CT-P42 submitted to FDA in June 2023) and Sandoz (Enzeevu™ approved August 2024, litigation pending).

The Court’s refusal to grant a preliminary injunction against Amgen differs from decisions of the US District Court for the Northern District of Virginia to grant preliminary injunctions against Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025), Formycon (21 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025), and a permanent injunction against Biocon (11 June 2024), based on findings of infringement of the US 865 patent. Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024. That appeal remains pending. The aflibercept biosimilars of each of Samsung Bioepis, Formycon, Celltrion and Biocon are buffered.

Samsung Bioepis, Formycon and Celltrion are challenging the validity of Regeneron’s ‘865 patent before the USPTO, each having filed a petition for IPR (inter partes review) in November 2024, December 2024 and January 2025, respectively.

The End of the Road: High Court refuses Bayer’s Rivaroxaban Patents Special Leave Application

Mar 14, 2025

Last year, we reported on Sandoz’ victory in its appeal regarding the validity of two of Bayer’s Australian Xarelto® (rivaroxaban) patents. In that appeal, the Full Court unanimously overturned the primary judge’s decision, holding that the two Bayer patents lacked an inventive step in light of the common general knowledge taken together with a prior art patent specification. Bayer applied to the High Court of Australia for special leave to appeal the Full Court’s decision. Last week, the High Court refused Bayer’s special leave application on the basis that Bayer’s application did not raise an issue of principle sufficient to warrant a grant of special leave and that the proposed appeal had insufficient prospects of success.

The High Court’s rejection of Bayer’s special application is important for two key reasons. First, it marks the end of the road for Bayer’s domination of the Australian rivaroxaban market. Secondly, it means that the Full Court’s decision stands, a significant decision which has clarified the bar that needs to be met to prove obviousness and which has recalibrated the “ascertainment” test under the “pre-Raising the Bar” version of the Australian Patents Act.

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.

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information.

Throughout her career, Helen has maintained a strong focus on high-value patent mandates involving complex technologies. In these mandates, Helen has been able to draw upon her technical training in biochemistry and molecular biology, as well as her ability to up-skill swiftly in relation to diverse technologies. Helen’s patent work has encompassed the technical fields of inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology) and physics.

Helen is a member of the Intellectual Property Committee of the Law Council of Australia, as well as a member of the Intellectual Property Society of Australia and New Zealand.

Lumicera Announces US Purchase Agreement with Teva Subsidiary for Alvotech’s Biosimilar Ustekinumab

Mar 13, 2025

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 Janssen’s Stelara®.

Under the agreement, Lumicera’s discounted net acquisition cost is estimated to generate USD$120 million in annualised savings. These savings will be accessed immediately through Lumicera’s pass-through, acquisition cost-plus model, not delayed through a rebated model. Plan sponsors will save between USD$112,000 and $336,000 per patient per year compared to the annual per-patient cost of the reference product.

Earlier this year, on 21 February 2025, Alvotech and Teva announced the US launch of ustekinumab biosimilar, Selarsdi® (AVT04, ustekinumab-aekn for injection). This followed Alvotech’s and Teva’s US ustekinumab settlement with Johnson & Johnson in June 2023, which permitted US launch of the biosimilar from 21 February 2025.

Selarsdi® was developed by Alvotech and is commercialised by Teva in the US, pursuant to an agreement for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates. The partnership was expanded in July 2023 to include four additional products.

Sixth US Biosimilar Ustekinumab Launched by Celltrion

Mar 13, 2025

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 psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and paediatric psoriatic arthritis.

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® received US FDA approval in December 2024 and was launched across 5 major EU countries in January 2025.

The US launch of Steqeyma® follows the US launches of Formycon/Fresenius Kabi’s Otulfi®/FYB202 (ustekinumab-aauz) in early March 2025, Sandoz/Samsung Bioepis’ Pyzchiva® (ustekinumab-ttwe) and Biocon’s Yesintek™ (ustekinumab-kfce/Bmab 1200) on 24 February 2025, Alvotech/Teva’s Selarsdi® (ustekinumab-aekn) on 21 February 2025 and Amgen’s Wezlana® (ustekinumab-auub) in early January 2025 (through Optum Health Solution’s private label subsidiary Nuvaila).

New Zealand’s Pharmac Approves Funding for Pfizer’s Besponsa® (Inotuzumab Ozogamicin)

Mar 12, 2025

On 12 March 2025, New Zealand’s Pharmac announces that it has entered an agreement with Pfizer to fund a range of drugs from 1 April 2025, including its Besponsa® (inotuzumab ozogamicin) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL).

The agreement comes after Pharmac sought feedback on proposals to fund Besponsa® in December 2024.

Approval Alert: Amgen’s Uplizna® (Inebilizumab) Approved in Australia

Mar 12, 2025

On 12 March 2025, Australia’s Therapeutic Goods Administration (TGA) approved Amgen’s Uplizna® (Inebilizumab) for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.

Uplizna® has received previous approvals in other jurisdictions, including in the US (June 2020) and the EU (April 2022).

Inebilizumab was developed by Horizon Therapeutics before being acquired by Amgen in a $27.8 billion deal reached in December 2022.

Approval Alert: Cipla’s Generic Liraglutide Second to be Approved in Australia

Mar 12, 2025

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:

CIPLA LIRAGLUTIDE: liraglutide 6 mg/mL solution for injection pre-filled pen (424371)
LIRAGLUTIDE SANDOZ: liraglutide 6 mg/mL solution for injection pre-filled pen (449145)
ARX-LIRAGLUTIDE: liraglutide 6 mg/mL solution for injection pre-filled pen (424370)

All three brands (one of which will be marketed by Sandoz and another by Arrotex), are indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:

≥30 kg/m² (obese); or
≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.

The approval closely trails Sun Pharma’s generic liraglutide, which was approved in Australia across three brands for the same indication on 6 March 2025. Cipla’s liraglutide was accepted for review by the TGA in October 2023. Freyr’s Lobezyl® remains as the only other generic liraglutide currently under review by the TGA (accepted for review in September 2024).

On 12 December 2024, the Federal Court of Australia rejected Cipla’s challenge to the patent term extension of Novo Nordisk’s liraglutide formulation patent (AU 2004290862). As a result, the term of the AU formulation patent remains due to expire in August 2025. The Federal Court decision has not been appealed.

Intas’ Ophthalmic Bevacizumab Biosimilar to Enter Ph 2/3 Trials

Mar 12, 2025

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 conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

The only currently authorised ophthalmic bevacizumab is Outlook Therapeutics’ Lytenava™ (ONS-5010, bevacizumab-vikg), which received marketing authorisation in the EU in May 2024 and was approved in the UK in July 2024 following submission of a marketing authorisation application to the MHRA under the International Recognition Procedure (IRP). Outlook Therapeutics resubmitted a BLA to the US FDA for ONS-5010 in February 2025 after the FDA issued a complete response letter in 2023.

Celltrion Rebrands Canadian Biosimilar Infliximab to Remdantry™

Mar 11, 2025

On 11 March 2025, Celltrion announced that its biosimilar infliximab for injection, currently known as Inflectra®, will be rebranded to Remdantry™ in Canada commencing on 1 April 2025. The formulation, indications and dosages of Remdantry™ will remain the same as those for Inflectra®.

According to Celltrion, the rebrand reflects its “consolidation of both the intravenous (IV) and subcutaneous (SC) formulations” being directly commercialised by Celltrion in Canada in order to “provide healthcare professionals with a more streamlined prescribing experience”.

Inflectra®, biosimilar to Janssen’s Remicade®, was approved by Health Canada for the treatment of rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in January 2014 and for Crohn’s disease (CD), fistulising Crohn’s disease and ulcerative colitis (UC) in June 2016.

Celltrion’s SC infliximab, Remsima™ SC, was approved by Health Canada for RA in January 2021 and for UC and Crohn’s disease in February 2024.

Pearce IP BioBlast® for the week ending 7 March 2025

Mar 10, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 7 March 2025 are set out below:

Aflibercept

5 March 2025 | US | US Appeals Court Affirms Injunction Preventing Launch of Celltrion’s Aflibercept Biosimilar

On 5 March 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Celltrion from launching its biosimilar to Regeneron’s Eylea® (aflibercept) in… Read more here.

COVID-19 mRNA Vaccine; Respiratory Syncytial Virus Vaccine

3 March 2025 | CA | JP | CH | EU | Genevant/Arbutus Files 5 International Infringement Actions Against Moderna Relating to LNP Technology

On 3 March 2025, Genevant Sciences and Arbutus Biopharma announced that they have jointly filed five international lawsuits seeking to enforce patents protecting their lipid nanoparticle (LNP) technology against… Read more here.

Denosumab

7 March 2025 | US | Amgen and Fresenius Kabi Settle US BPCIA Denosumab Litigation

On 7 March 2025, the US District Court for the District of New Jersey ordered the dismissal of all claims and counterclaims in Amgen’s BPCIA patent infringement proceeding against Fresenius Kabi… Read more here.

3 March 2025 | US | Approval Alert: Celltrion’s Biosimilar Denosumab Third to be Approved in US

On 3 March 2025, Celltrion announced that it has received US FDA approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the… Read more here.

3 March 2025 | US | FDA Accepts Amneal/mAbxience’s Denosumab BLA for Review

On 3 March 2025, Amneal Pharmaceuticals and mAbxience announced that the FDA has accepted for review their aBLA for two new denosumab biosimilars referencing Amgen’s Prolia® and Xgeva®… Read more here.

Eculizumab

5 March 2025 | US | Amgen Launches First US Eculizumab Biosimilar with Interchangeability

On 5 March 2025, Generics Bulletin reported that Amgen has launched Bkemv® (eculizumab-aeeb) in the US as the first available interchangeable biosimilar to Alexion’s Soliris®… Read more here.

4 March 2025 | US | New Indication Alert: Soliris® (Eculizumab) Approved in US for Paediatric Myasthenia Gravis

On 4 March 2025, NeurologyLive reported that the US FDA has approved an expanded indication of Alexion/AstraZeneca’s Soliris® (eculizumab) to include both adult and paediatric patients 6 years of… Read more here.

Lecanemab

6 March 2025 | UK | Eisai/Biogen’s Leqembi® Receives Further Reimbursement Consideration by UK’s NICE for Early Alzheimer’s Disease

On 6 March 2025, the UK’s National Institute for Health and Care Excellence (NICE) opened a second consultation period in respect of the use of Eisai/Biogen’s Leqembi® (lecanemab) on the NHS in… Read more here.

3 March 2025 | AU | Eisai/Biogen’s Leqembi® (Lecanemab) Rejected by Australia’s TGA

On 3 March 2025, Eisai and Biogen announced that Australia’s Therapeutic Goods Administration (TGA) has confirmed its initial decision to decline the approval of Leqembi® (lecanemab) for the… Read more here.

Liraglutide

6 March 2025 | AU | Approval Alert: Sun Pharma Achieves First Generic Liraglutide Approval in Australia

On 6 March 2025, Sun Pharma’s liraglutide became the first approved generic to Novo Nordisk’s Saxenda® in Australia. The product was approved by Australia’s Therapeutic Goods… Read more here.

Nivolumab, Ipilimumab

7 March 2025 | EU | New Indication Alert: BMS’ Opdivo®/Yervoy® Combo EU-Approved for First Line Treatment of Unresectable/Advanced HCC

On 7 March 2025, Bristol Myers Squibb (BMS) announced that the European Commission has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first line treatment of adults with… Read more here.

28 February 2025 | US | Amgen Challenges Validity of BMS’ US Patents for Methods of Treatment Using Opdivo®/Yervoy®

On 28 February 2025, Amgen filed petitions for inter partes review (IPR) challenging the validity of three of Bristol Myers Squibb’s US patents relating to methods of treatment using nivolumab and… Read more here.

Omalizumab

7 March 2025 | US | Approval Alert: FDA Approves Celltrion’s Omlyclo® as First Interchangeable Omalizumab Biosimilar

On 7 March 2025, the US FDA approved Celltrion’s Omlyclo® (omalizumab-igec, CT-P39), as the first interchangeable biosimilar to Genentech/Novartis’ Xolair® (omalizumab). Omlyclo® is approved as a… Read more here.

Pembrolizumab

5 March 2025 | US | Merck (MSD) and Halozyme in US Patent Dispute as Subcutaneous Pembrolizumab Launch Approaches

On 5 March 2025, the Wall Street Journal (WSJ) reported that Halozyme Therapeutics has offered Merck (known as MSD outside the US and Canada) an opportunity to licence patents owned by Halozyme… Read more here.

Risankizumab

4 March 2025 | CA | AbbVie Launches Skyrizi® (Risankizumab) in Canada for UC

On 4 March 2025, AbbVie announced that Skyrizi® (risankizumab) is now available in Canada for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had… Read more here.

Tislelizumab

4 March 2025 | US | New Indication Alert: FDA Approves BeiGene’s Tevimbra® for ESCC

On 4 March 2025, BeiGene announced that the US FDA has approved its Tevimbra® (tislelizumab), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with … Read more here.

Ustekinumab

7 March 2025 | Biocon Announces Positive Ph 3 Results for Biosimilar Ustekinumab

On 7 March 2025, Biocon Biologics announced the results of a Phase 3 study comparing Yesintek™ (biosimilar ustekinumab) with J&J/Janssen’s Stelara® in adults with moderate to severe chronic … Read more here.

3 March 2025 | Formycon/Fresenius Kabi Launches Fourth Biosimilar Ustekinumab in US

On 3 March 2025, Fresenius announced the US launch of Otulfi®/FYB202 (ustekinumab-aauz), biosimilar to J&J/Janssen’s Stelara®… 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

Law Graduate

Nathan is a law graduate focused on providing 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.

Coherus Exits Biosimilar Business with Pegfilgrastim Sale to Accord BioPharma

Mar 10, 2025

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’ specialty unit, Accord BioPharma. The move will reduce Coherus’ workforce by around 30%, leaving it with approximately 155 employees.

The divestiture follows Coherus’ December 2024 agreement with Accord’s parent company, Intas Pharmaceuticals, for the sale of its pegfilgrastim (Udenyca®), biosimilar to Amgen’s Neulasta®, under which Coherus received USD$483.4 million upfront, with up to USD$75 million in potential milestone payments based on net sales performance. With the Udenyca® divesture, Coherus has now fully transition away from biosimilars, refocusing on its immune-oncology pipeline.

The addition of Udenyca® to Accord’s portfolio follows a number of important milestones achieved by the company for its biosimilar pipeline in recent months. In February 2025, Intas and Bio-Thera reached an exclusive commercialisation and licence agreement for golimumab (BAT2506), biosimilar to J&J’s Simponi® and Simponi Aria®, under which Accord will be responsible for commercialising the product in the US and Bio-Thera will retain responsibility for development, manufacturing and supply.

In December 2024, the European Commission granted marketing authorisation for Accord Healthcare’s Imuldosa®, biosimilar ustekinumab, for a range of immune medicated inflammatory diseases. Imuldosa® was developed jointly by Dong-A Socio Holdings and Meiji Seika Pharma. In July 2021, Dong-A ST signed a global out-licensing agreement with Intas Pharmaceuticals. Imuldosa® will be launched in multiple regions, through Intas and its subsidiaries, including Accord Biopharma in the United States and Accord Healthcare in Europe, the UK, and Canada.

Sun Pharma to Acquire Checkpoint Therapeutics

Mar 9, 2025

On 9 March 2025, Sun Pharma and Checkpoint Therapeutics announced that they have entered into an agreement for Sun Pharma to acquire Checkpoint Therapeutics. Under the deal, Sun Pharma will own Checkpoint’s leading biopharmaceutical Unloxcyt™ (cosibelimab).

Unloxcyt™ received FDA approval in December 2024 for the treatment of adults with metastatic cutaneous squamous cell carcinoma or locally advanced cSCC who are not candidates for curative surgery or curative radiation. The approval followed Checkpoint Therapeutics resubmission of its BLA to the FDA in July 2024.

According to the announcement, Checkpoint Therapeutics shareholders will receive a cash payment of USD$4.10 per share, but will be entitled to receive an additional USD$0.70 per share if cosibelimab is approved prior to certain deadlines in the European Union pursuant to the centralised approval procedure, or in Germany, France, Italy, Spain or the United Kingdom, subject to the terms and conditions in the agreement.

Biocon Announces Positive Ph 3 Results for Biosimilar Ustekinumab

Mar 7, 2025

On 7 March 2025, Biocon Biologics announced the results of a Phase 3 study comparing Yesintek™ (biosimilar ustekinumab) with J&J/Janssen’s Stelara® in adults with moderate to severe chronic plaque psoriasis (PsO). The study reportedly demonstrated equivalent efficacy, safety, immunogenicity and pharmacokinetics between the biosimilar and its reference product and continued efficacy and safety of switching from Stelara® to Yesintek™ from week 16 to week 52. Biocon intends to present the results at the March 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.

Biocon launched Yesintek™ in the US in February 2025 following its approval in early December 2024 for adult patients with moderate to severe PsO who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis.

The European Commission granted marketing authorisation for Yesintek™ in February 2025 for the treatment of adults and children with plaque psoriasis and treatment of adults with psoriatic arthritis and Crohn’s disease. The European approval followed a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on 14 December 2024.

Approval Alert: FDA Approves Celltrion’s Omlyclo® as First Interchangeable Omalizumab Biosimilar

Mar 7, 2025

On 7 March 2025, the US FDA approved Celltrion’s Omlyclo® (omalizumab-igec, CT-P39), as the first interchangeable biosimilar to Genentech/Novartis’ Xolair® (omalizumab). Omlyclo® is approved as a 75 mg/0.5ml and 150mg/ml injection in a single pre-filled syringe for subcutaneous use. The approval covers all US indications of Xolair®, including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy and chronic spontaneous urticaria.

Omlyclo® was the first omalizumab biosimilar to be approved in Canada (December 2024), Australia (November 2024), the UK (July 2024), South Korea (June 2024), and Europe (May 2024).

On 30 January 2025, the Patents Court (England and Wales) ruled that Genentech/Novartis’ UK patent for a formulation of omalizumab (EP (UK) 3 805 248) was valid and infringed by Celltrion. The UK Court judgment followed a decision of the Dusseldorf Local Division of the UPC in September 2024, which rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion for “imminent infringement” of the EP ‘248 patent.

Disputes between Novartis/Genentech and Celltrion regarding omalizumab are ongoing in the Netherlands (with accelerated proceedings on the merits before the District Court of The Hague), and in the European Patent Office (EPO), where Celltrion (and another party) filed an opposition against EP 3 805 248 in October 2023. In a preliminary opinion issued on 2 September 2024, the Opposition Division of the EPO indicated its view that EP ‘248 is valid. The oral proceedings in the opposition are due to take place in April 2025.

Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark have previously been reported to have omalizumab biosimilars under development.

New Indication Alert: BMS’ Opdivo®/Yervoy® Combo EU-Approved for First Line Treatment of Unresectable/Advanced HCC

Mar 7, 2025

On 7 March 2025, Bristol Myers Squibb (BMS) announced that the European Commission has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first line treatment of adults with unresectable or advanced hepatocellular carcinoma (HCC). The EC approval follows the CHMP’s positive opinion for the expanded indication in January 2025.

The same indication for the Opdivo®/Yervoy® combination is currently under review by the FDA, with BMS’ sBLA accepted in August 2024. The FDA assigned a PDUFA goal date of 21 April 2025.

In December 2024, the European Commission approved Opdivo®/Yervoy® for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). Applications for this indication are also pending in countries including the US (sBLA accepted in February 2025), Australia (TGA application filed in July 2024) and Japan (supplemental application filed in September 2024).

New Indication Alert: AstraZeneca’s Durvalumab Approved in India for Limited-Stage Small Cell Lung Cancer

Mar 7, 2025

On 7 March 2025, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved its Imfinzi® (durvalumab) 120 mg/2.4 mL and 500 mg/10 mL solution for infusion, for the treatment of patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).

In February this year, the EU’s CHMP recommended Imfinzi® for the new indication of treating adults with resectable NSCLC at high risk of recurrence, and in January, recommended Imfinzi® for LS-SCLC.

Also in February 2025, Australia’s TGA is accepted for review an indication expansion of Imfinzi® for muscle invasive bladder cancer, and was approved for LS-SCLC later thatd month.

In January 2025, the UK’s NICE recommended Imfinzi® in combination with chemotherapy (etoposide) plus either carboplatin or cisplatin for the treatment of adults with untreated extensive- SCLC

Amgen and Fresenius Kabi Settle US BPCIA Denosumab Litigation

Mar 7, 2025

On 7 March 2025, the US District Court for the District of New Jersey ordered the dismissal of all claims and counterclaims in Amgen’s BPCIA patent infringement proceeding against Fresenius Kabi in relation to its denosumab biosimilar. The order followed a stipulation by the parties as to their settlement of the litigation, which was filed with the Court on 4 March 2025.

Neither Amgen nor Fresenius Kabi have issued press releases about the settlement as at the date of this report and the terms on which the proceeding was settled, including the US launch date for Fresenius’ denosumab biosimilars, are currently unknown.

Amgen originally commenced proceedings against Fresenius Kabi on 4 October 2024 in the US District Court for the Northern District of Illinois (Eastern Division) alleging infringement of 33 US patents relating to denosumab. The litigation followed Fresenius’ submission of an abbreviated Biologics Licence Application (aBLA) to the US FDA seeking approval to manufacture and sell its FKS518, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab). Fresenius’ aBLA for denosumab was accepted for review by the FDA on 27 May 2024.

In the context of the litigation, Amgen issued a subpoena to Cytiva subsidiary media supplier HyClone Laboratories requesting information including the full formulation of HyClone’s off-the-shelf cell culture supplement, HyClone™ Cell Boost™ 7a (CB7A). Amgen has now withdrawn that subpoena given the settlement of the underlying litigation with Fresenius.

The BPCIA proceeding against Fresenius was one of five that Amgen had commenced in the US in relation to denosumab biosimilars, which were centralised in the US District Court for the District of New Jersey in February 2025. 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. The remaining court proceedings, against Samsung Bioepis (Ospomyv™/Xbryk™/SB16 approved February 2025, litigation commenced August 2024) and Accord/Intas (INTP23, litigation commenced November 2024), remain pending.

Approval Alert: Sun Pharma Achieves First Generic Liraglutide Approval in Australia

Mar 6, 2025

On 6 March 2025, Sun Pharma’s liraglutide became the first approved generic to Novo Nordisk’s Saxenda® in Australia. The product was approved by Australia’s Therapeutic Goods Administration (TGA) across three brands:

Benedo: liraglutide 6 mg/mL solution for injection pre-filled pen (428573);
Liraglutide RBX: liraglutide 6 mg/mL solution for injection pre-filled pen (428571); and
Liraglutide Sun: liraglutide 6 mg/mL solution for injection pre-filled pen (428572).

All three brands are indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:

≥30 kg/m² (obese); or
≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.

Sun Pharma’s generic liraglutide was accepted for review by the TGA in January 2024. There are currently two other generic liraglutide products being reviewed by the TGA: Freyr’s Lobezyl® (accepted for review in September 2024) and Cipla’s unnamed generic liraglutide (accepted for review in October 2023).

On 12 December 2024, the Federal Court of Australia rejected Cipla’s challenge to the patent term extension of Novo Nordisk’s liraglutide formulation patent (AU 2004290862). As a result, the term of the AU formulation patent remains due to expire in August 2025. The Federal Court decision has not been appealed.

Adalvo’s generic liraglutide was the first to be approved in the EU in June 2024, while Biocon’s liraglutide was the first generic approved in the UK in March 2024. Teva Pharmaceuticals launched the first authorised generic liraglutide in the US in June 2024.

Eisai/Biogen’s Leqembi® Receives Further Reimbursement Consideration by UK’s NICE for Early Alzheimer’s Disease

Mar 6, 2025

On 6 March 2025, the UK’s National Institute for Health and Care Excellence (NICE) opened a second consultation period in respect of the use of Eisai/Biogen’s Leqembi® (lecanemab) on the NHS in England for treating mild cognitive impairment (MCI) or mild dementia caused by Alzheimer’s disease. The consultation follows NICE’s draft guidance in August 2024 determining that the benefits of lecanemab were too small to warrant making the drug available on the NHS for this indication.

The closing date for comments to be provided to the evaluation committee is 27 March 2025. An evaluation committee meeting is scheduled for 14 May 2025, with publication of the decision expected in July 2025.

The UK was the first country in Europe to authorise Leqembi® in August 2024 for the treatment of MCI or mild dementia due to Alzheimer’s disease. After NICE’s draft guidance against recommending making the drug available on the NHS for this indication, in February 2025, the Scottish Medicines Consortium (SMC) similarly declined to recommend reimbursement of Leqembi® for treating early-stage Alzheimer’s disease, citing uncertainties surrounding the drug’s clinical benefits and cost-effectiveness.

Leqembi® has been approved for MCI and mild dementia due to Alzheimer’s disease in the US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland. While Australia’s Therapeutic Goods Administration (TGA) has declined to approve Leqembi® (lecanemab) for the treatment for early Alzheimer’s Disease, in February 2025, the CHMP reaffirmed its positive recommendation for approval of this indication.

MSD and Halozyme in US Patent Dispute as Subcutaneous Pembrolizumab Launch Approaches

Mar 5, 2025

On 5 March 2025, the Wall Street Journal (WSJ) reported that Halozyme Therapeutics has offered MSD an opportunity to licence patents owned by Halozyme in relation to a specific enzyme, known as Mdase. Halozyme executives reportedly claimed during a recent investor conference that MSD’s subcutaneous (SC) version of Keytruda® (pembrolizumab) infringes those patents.

WSJ reports that a spokesperson from MSD said the enzyme used in SC Keytruda® was “developed independently” from Halozyme and that MSD “strongly believe” that any Halozyme patents that attempt to cover the enzyme variant are invalid.

The WSJ report follows petitions for post-grant review filed by MSD with the US Patent Trial and Appeal Board challenging the validity of seven of Halozyme’s US patents. The petitions, which are currently pending, were filed between November 2024 and February 2025 in relation to: US 11952600, US 12018298, US 12152262, US 12123035, US 12110520, US 12054758 and US 12060590.

In November 2024, MSD revealed positive topline results from its Phase 3 trial evaluating SC pembrolizumab (MK-3475A), together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy. The SC pembrolizumab demonstrated noninferior pharmacokinetics compared to intravenous (IV) Keytruda® (pembrolizumab) in combination with chemotherapy, in adults with metastatic non-small cell lung cancer (NSCLC). At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, MSD announced an expected 2025 launch for SC Keytruda®.

MSD and Halozyme in US Patent Dispute as Subcutaneous Pembrolizumab Launch Approaches

Mar 5, 2025

On 5 March 2025, the Wall Street Journal (WSJ) reported that Halozyme Therapeutics has offered MSD an opportunity to licence patents owned by Halozyme in relation to a specific enzyme, known as Mdase. Halozyme executives reportedly claimed during a recent investor conference that MSD’s subcutaneous (SC) version of Keytruda® (pembrolizumab) infringes those patents.

WSJ reports that a spokesperson from MSD said the enzyme used in SC Keytruda® was “developed independently” from Halozyme and that MSD “strongly believe” that any Halozyme patents that attempt to cover the enzyme variant are invalid.

The WSJ report follows petitions for post-grant review filed by MSD with the US Patent Trial and Appeal Board challenging the validity of seven of Halozyme’s US patents. The petitions, which are currently pending, were filed between November 2024 and February 2025 in relation to: US 11952600, US 12018298, US 12152262, US 12123035, US 12110520, US 12054758 and US 12060590.

In November 2024, MSD revealed positive topline results from its Phase 3 trial evaluating SC pembrolizumab (MK-3475A), together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy. The SC pembrolizumab demonstrated noninferior pharmacokinetics compared to intravenous (IV) Keytruda® (pembrolizumab) in combination with chemotherapy, in adults with metastatic non-small cell lung cancer (NSCLC). At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, MSD announced an expected 2025 launch for SC Keytruda®.

Amgen Launches First US Eculizumab Biosimilar with Interchangeability

Mar 5, 2025

On 5 March 2025, Generics Bulletin reported that Amgen has launched Bkemv® (eculizumab-aeeb) in the US as the first available interchangeable biosimilar to Alexion’s Soliris®.

Bkemv® was approved by the FDA in May 2024 for the same indications as Soliris® (atypical haemolytic uremic syndrome (aHUS) and paroxysmal nocturnal haemoglobinuria (PNH)), and in the same dosage form and strength.

The timing of the US launch of Bkemv® was governed by a settlement reached by Amgen and Alexion in May 2020, permitting launch from 1 March 2025. The only other eculizumab biosimilar currently approved in the US is Samsung Bioepis’ Epysqli® (SB12) (approved July 2024).

Amgen’s eculizumab biosimilar was approved in the EU as Bekemv® in April 2023. On 19 March 2024, Alexion filed proceedings against Amgen in the Unified Patents Court (UPC), seeking provisional measures in relation to alleged infringement of EP3167888, concerning a method of treating PNH using eculizumab. The UPC (June/July 2024) and the UPC Court of Appeal (December 2024) refused to grant preliminary injunctions against Amgen (and Samsung Bioepis) in relation to the sale of their eculizumab biosimilars in the EU.

Biosimilars Deals 2021

About Pearce IP

Naomi Pearce

Helen Macpherson

Aflibercept

COVID-19 mRNA Vaccine; Respiratory Syncytial Virus Vaccine

Denosumab

Eculizumab

Lecanemab

Liraglutide

Nivolumab, Ipilimumab

Omalizumab

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Tislelizumab

Ustekinumab

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

Product specific reports based on extracts from our BioBlast® database

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