Biosimilars Deals 2021 Archives

Pearce IP BioBlast® for the week ending 16 May 2025

May 21, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 16 May 2025 are set out below:

Alirocumab, Evolocumab

15 May 2025 | US | US Jury Awards Regeneron Over US$400M in Damages: Amgen Prevented Competition Between PCSK9 Inhibitors

On 15 May 2025, Regeneron announced that a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws by using cross-therapeutic… Read more here.

Dupilumab

14 May 2025 | SG | New Indication Alert: Singapore Approves Dupixent® (Dupilumab) for COPD

On 14 May 2025, Sanofi announced that Singapore’s Health Sciences Authority (HSA) has approved Dupixent® (dupilumab) for adults as an add-on maintenance treatment for uncontrolled chronic…. Read more here.

Eculizumab

12 May 2025 | CA | Court Grants Injunction Delaying Amgen’s Canadian Launch of Biosimilar Eculizumab

On 12 May 2025, the Canadian Federal Court published a decision (issued on 28 April 2025 on a confidential basis) granting Alexion an injunction preventing the Canadian launch of Amgen’s Bkemv®… Read more here.

Nivolumab

16 May 2025 | EU | New Indication Alert: BMS’ Opdivo® (Nivolumab) Combo Approved in Europe for NSCLC

On 16 May 2025, Bristol Myers Squibb announced that the European Commission (EC) has approved the perioperative regimen of neoadjuvant Opdivo® (nivolumab) and chemotherapy followed by… Read more here.

Trastuzumab deruxtecan

8 May 2025 | IN | New Indication Alert: India Approves AstraZeneca’s Enhertu® (Trastuzumab Deruxtecan) for Breast Cancer

On 8 May 2025, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved an indication extension for Enhertu® (trastuzumab deruxtecan) in 100 mg… 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

Graduate (Law)

Nathan is a Graduate (Law) 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.

US Jury Awards Regeneron Over US$400M in Damages: Amgen Prevented Competition Between PCSK9 Inhibitors

May 21, 2025

On 15 May 2025, Regeneron announced that a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws by using cross-therapeutic bundling rebates, involving its anti-inflammatory drugs Enbrel® (etanercept) and Otezla® (apremilast), to convince pharmacy benefit managers (PBMs) to choose Repatha® (evolocumab) as their exclusive PCKS9 product, instead of Regeneron’s Praluent® (alirocumab). According to Regeneron, Amgen threatened to withhold rebates unless PBMs preferred its cholesterol-lowering antibody, Repatha®, and excluded Regeneron’s Praluent®.

The jury awarded Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages. It is not yet known whether Amgen will appeal the decision.

On 18 May 2023, the US Supreme Court invalidated antibody genus claims in two Amgen patents relating to Repatha® (evolocumab). On 16 July 2024, the Munich Central Division of the UPC issued judgment in revocation actions brought by Sanofi and Regeneron, declaring Amgen’s evolocumab patent EP3666797 invalid, based on lack of inventive step. Amgen has recently had more fortune in Australia, where, on 23 April 2025, the Federal Court determined that five of Amgen’s evolocumab-related patent applications are valid and should proceed to grant.

New Indication Alert: BMS’ Opdivo® (Nivolumab) Combo Approved in Europe for NSCLC

May 16, 2025

On 16 May 2025, Bristol Myers Squibb announced that the European Commission (EC) has approved the perioperative regimen of neoadjuvant Opdivo® (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo® for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥1%.

This follows the March 2025 CHMP recommendation for the indication. At its March 2025 meeting, the CHMP also recommended the approval of a new Opdivo® formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). Subcutaneous Opdivo® has previously been approved in the US (December 2024) and the UK (April 2025) for most but not all previously approved adult, solid tumour indications.

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development or in contemplation.

US Jury Awards Regeneron Over US$400M in Damages: Amgen Prevented Competition Between PCSK9 Inhibitors

May 15, 2025

On 15 May 2025, Regeneron announced that a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws by using cross-therapeutic bundling rebates, involving its anti-inflammatory drugs Enbrel® (etanercept) and Otezla® (apremilast), to convince pharmacy benefit managers (PBMs) to choose Repatha® (evolocumab) as their exclusive PCKS9 product, instead of Regeneron’s Praluent® (alirocumab). According to Regeneron, Amgen threatened to withhold rebates unless PBMs preferred its cholesterol-lowering antibody, Repatha®, and excluded Regeneron’s Praluent®.

The jury awarded Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages. It is not yet known whether Amgen will appeal the decision.

On 18 May 2023, the US Supreme Court invalidated antibody genus claims in two Amgen patents relating to Repatha® (evolocumab). On 16 July 2024, the Munich Central Division of the UPC issued judgment in revocation actions brought by Sanofi and Regeneron, declaring Amgen’s evolocumab patent EP3666797 invalid, based on lack of inventive step. Amgen has recently had more fortune in Australia, where, on 23 April 2025, the Federal Court determined that five of Amgen’s evolocumab-related patent applications are valid and should proceed to grant.

New Indication Alert: Singapore Approves Dupixent® (Dupilumab) for COPD

May 14, 2025

On 14 May 2025, Sanofi announced that Singapore’s Health Sciences Authority (HSA) has approved Dupixent® (dupilumab) for adults as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils who are on a stable combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

In Singapore, Dupixent® is the first biologic medicine approved to treat these COPD patients and follows approval of the same indication in Japan in March 2025.

Dupixent® was also 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.

Dupixent® was also recently approved by the US FDA for Chronic Spontaneous Urticaria (CSU) in April 2025. Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil.

Pearce IP BioBlast® for the week ending 9 May 2025

May 13, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 9 May 2025 are set out below:

Aflibercept

9 May 2025 | JP | Regeneron/Bayer Seek Japanese Approval of Aflibercept 8mg for Macular Oedema

On 9 May 2025, Bayer announced that it has submitted a marketing authorisation application to the Ministry of Health, Labour and Welfare in Japan for Eylea™/aflibercept 8mg for treating patients… Read more here.

Pembrolizumab

9 May 2025 | NZ | New Zealand’s Pharmac to Widen Access to MSD’s Keytruda® (Pembrolizumab) for Melanoma

On 9 May 2025, New Zealand’s drug funding body, Pharmac, announced that it will be widening access to treatments for melanoma from 1 June 2025, including funding MSD’s Keytruda® (pembrolizumab)…. Read more here.

Ustekinumab

5 May 2025 | US | FDA Approves Interchangeability of Alvotech/Teva’s Selarsdi® with J&J’s Stelara® (Ustekinumab)

On 5 May 2025, Alvotech and Teva announced that the US FDA has approved Selarsdi® (ustekinumab-aekn) as interchangeable with J&J’s Stelara® (ustekinumab) in all presentations… Read more here.

5 May 2025 | US | Biocon Secures Multiple US Market Access Agreements for Biosimilar Ustekinumab

On 5 May 2025, Biocon Biologics announced that it has entered multiple market access agreements in the US for Yesintek®, biosimilar to J&J’s Stelara® (ustekinumab). This includes the addition of… Read more here.

Biosimilar Regulation

6 May 2025 | IN | India’s CDSCO Publishes Draft Revised Biosimilar Guidelines for Stakeholder Comment

On 6 May 2025, India’s Central Drugs Standard Control Organization (CDSCO) published draft revised guidelines on biosimilars, which update marketing authorisation requirements for biosimilars in line … Read more here.