Biosimilars Deals 2021 Archives | Page 2 of 8

Pearce IP BioBlast® for the week ending 13 June 2025

Jun 17, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 13 June 2025 are set out below:

Bevacizumab

10 June 2025 | GB-SCT | Outlook Therapeutics’ Ophthalmic Bevacizumab Accepted for Use Within NHS Scotland

On 10 June 2025, Outlook Therapeutics announced that the Scottish Medicines Consortium has accepted Lytenava™ (bevacizumab gamma) for use within NHS Scotland for the treatment of wet… Read more here.

Pembrolizumab

12 June 2025 | US | New Indication Alert: MSD’s Keytruda® (Pembrolizumab) FDA-Approved For Perioperative Treatment for HNSCC

On 12 June 2025, the US FDA announced that it has approved MSD’s Keytruda® (pembrolizumab) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose… Read more here.

9 June 2025 | US | PTAB Invalidates Johns Hopkins’ US Pembrolizumab MOT Patent in MSD’s IPR

On 9 June 2025, the US Patent Trial and Appeal Board issued a written decision invalidating all claims of Johns Hopkins University’s US Patent No. 11,591,393 on the basis of anticipation and obviousness… Read more here.

Rituximab

12 June 2025 | US | New Indication Alert: FDA Expands Indications for Celltrion’s, Pfizer’s and Amgen’s Rituximab Biosimilars

On 12 June 2025, Celltrion, Amgen and Pfizer each received FDA approval of an additional indication for their rituximab biosimilars (Truxima®, Riabni® and Ruxience®, respectively), for treatment of… Read more here.

Ustekinumab

16 June 2025 | US | FDA Approves New Presentation of Celltrion’s Ustekinumab Biosimilar

On 16 June 2025, Celltrion announced that the FDA has approved a new single-dose 45mg/0.5mL subcutaneous injection of Steqeyma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab)… Read more here.

9 June 2025 | JP | Samsung Bioepis Partners with Japan’s NIPRO for Biosims Including Ustekinumab

On 9 June 2025, Samsung Bioepis announced that it has entered into a partnership agreement with NIPRO Corporation in Japan for multiple biosimilars, including SB17, Samsung Bioepis’ biosimilar to… Read more here.

9 June 2025 | AU | Samsung Bioepis Successful in Federal Court Action to Revoke 3 AU Janssen Ustekinumab Patents

On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016). The Court’s revocation… Read more here.

Biopharma Deals

11 June 2025 | Xbrane Partners with OneSource for Biosimilar Manufacturing

On 11 June 2025, Sweden-based Xbrane Biopharma and OneSource Specialty Pharma, an Indian-based CDMO, announced that they have entered a partnership for the commercial manufacture of Xbrane’s biosimilar portfolio… 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.

Regeneron Files New US BPCIA Complaint Against Amgen for Pavblu™, Eylea® Biosimilar

Jun 17, 2025

On 17 June 2025, Regeneron filed a new BPCIA complaint against Amgen in the United States District Court for the Central District of California, asserting that Amgen’s Pavblu™/ABP 938 (aflibercept) infringes US 12,331,099, which claims an ophthalmic formulation of aflibercept. The US 099 patent was granted on the same date that Regeneron’s complaint was filed.

Regeneron is seeking an injunction preventing Amgen from infringing the US 099 patent, including by selling and distributing Pavblu™, damages in the form of lost profits, additional damages for wilful infringement and legal costs.

The new complaint follows the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen’s Pavblu™ in October 2024 in respect of another of Regeneron’s US formulation patents (US Patent No. 11,084,865). In the earlier case, 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 buffer.

Amgen’s Pavblu™, biosimilar to Regeneron’s Eylea® (aflibercept), was approved in August 2024 and launched in the US in October 2024 following the Court of Appeals’ decision.

Regeneron is seeking that the new complaint against Amgen be consolidated with its other pending aflibercept BPCIA litigation against each of Samsung Bioepis (2 actions; Opuviz™/SB15 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). Preliminary injunctions were granted, and remain in place, preventing biosimilar aflibercept launches by 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).

Regeneron settled US BPCIA litigation regarding aflibercept with Biocon in April 2025, paving the way for a US launch of Biocon’s biosimilar, Yesafili™ (approved May 2024) in the second half of 2026, or earlier under certain undisclosed circumstances.

Samsung Bioepis, Formycon and Celltrion have been challenging the validity of Regeneron’s US 11,084,865 before the USPTO, having each filed a petition for IPR (inter partes review) in November 2024, December 2024 and January 2025, respectively. On 2 June 2025, the PTAB denied institution of Samsung Bioepis’ and Formycon’s petitions including because the ‘865 patent is already the subject of the pending BPCIA litigation. Celltrion’s petition remains pending.

Pearce IP Ranked by MIP for Trade Mark Prosecution 2025

Jun 16, 2025

Pearce IP has been recognised for the first time by Managing IP Stars for trade mark prosecution in its 2025 Trade Mark rankings.

In addition to Pearce IP’s existing ranking for Patent Prosecution and 6 Pearce IP lawyers/attorneys honoured in 2025 MIP IP Stars 2025, we are delighted to be recognised by MIP as a Notable Firm for Trade Mark prosecution.

Pearce IP is one of 13 firms ranked by MIP in 2025 for Trade Mark prosecution.

Pearce IP’s CEO, Lawyer, Patent Attorney and Trade Mark Attorney Naomi Pearce says:

“I am thrilled for our trade mark team to be recognised by MIP as one of Australia’s leading prosecution firms.

Under the leadership of Executive Kimberley Evans since January 2024, the team has gone from strength to strength, delivering spectacular results for clients.

Congratulations to Kim, and to each of Pearce IP’s trade mark professionals and team members for this well deserved accolade.”

Pearce IP’s Executive and Head of Trade Marks Kimberley Evans says:

“I am delighted with this recognition which shows that our clients love working with us and trust us with the complex trade mark issues. We are well on our way to being the premier IP firm in Australia and New Zealand by 2027.”

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the pharmaceutical, biopharmaceutical and life sciences industries. 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. Pearce IP leaders are well recognised as leading IP practitioners.

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, Women in Law Awards – Partner of the Year, Best Lawyers and Australasian Lawyer 5 Star Awards, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

6 Pearce IP Lawyers/Attorneys Recognised by 2025 MIP IP STARS

Jun 16, 2025

We are thrilled to announce that 6 Pearce IP patent professionals have again been recognised by Managing IP in the 2025 MIP IP STARS, a leading global guide to the top intellectual property firms and practitioners.

Naomi Pearce and Helen Macpherson have been honoured as IP STARS in Australia;
Jacinta Flattery-O’Brien (AU), Paul Johns (NZ), and Julie Balance (NZ) have been ranked as Notable Practitioners; and
Donna Meredith (AU) is also acknowledged.

In its IP STARS rankings, MIP assesses firms and individuals based on market feedback, case outcomes, and peer recognition across contentious and non-contentious areas of IP law.

We are proud to have Pearce IP’s leading patent professionals listed as most trusted advocates and advisors. To view Pearce IP’s IP STARS profile, visit: Pearce IP on IP STARS.

Thank you to our clients and peers for your trust and respect, and congratulations to Naomi, Helen, Jacinta, Paul, Julie and Donna!

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the pharmaceutical, biopharmaceutical and life sciences industries. 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. Pearce IP leaders are well recognised as leading IP practitioners.

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, Women in Law Awards – Partner of the Year, Best Lawyers and Australasian Lawyer 5 Star Awards, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

FDA Approves New Presentation of Celltrion’s Ustekinumab Biosimilar

Jun 16, 2025

On 16 June 2025, Celltrion announced that the FDA has approved a new single-dose 45mg/0.5mL subcutaneous injection of Steqeyma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab). The new presentation is approved for the treatment of paediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis or psoriatic arthritis. The FDA has also granted Steqeyma® full interchangeability with Stelara® across all its indications.

Steqeyma® was first approved by the FDA in December 2024 in 45mg/0.5mL and 90mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion in adult and paediatric patients 6 years and older with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn’s disease and ulcerative colitis. Celltrion launched Steqeyma® in the US in these presentations in March 2025.

Amgen’s Wezlana® was the first ustekinumab biosimilar to be approved as interchangeable with Stelara® in the US in October 2023, followed by Alvotech/Teva’s Selarsdi® and Formycon/Fresenius’ FYB202/Otulfi®, both in May 2025.

There are a number of ustekinumab biosimilars now launched in the US including Amgen’s Wezlana® (Jan 2025), Alvotech/Teva’s Selarsdi® (Feb 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek® (Feb 2025), and Formycon/Fresenius Kabi’s Otulfi® (Mar 2025).

German Court Rules Samsung Bioepis/Biogen’s Adalimumab Biosimilar Infringes Fresenius Formulation Patent

Jun 16, 2025

On 16 June 2025, Korea Biomedical Review reported that the Dusseldorf Higher Regional Court ruled that Samsung Bioepis/Biogen’s Imraldi®, biosimilar to AbbVie’s Humira® (adalimumab), infringes a formulation patent held in Germany by Fresenius Kabi. The Fresenius patent, EP 3 145 488 B1, claims a liquid pharmaceutical composition consisting of 50 mg/mL adalimumab, a citrate buffering system, sugar stabiliser, tonicifier and surfactant in a certain molar ratio.

In overturning a 2022 decision of the Dusseldorf Regional Court, the Higher Court granted an injunction preventing Biogen’s sales of Imraldi® in Germany and ordering Biogen to recall and destroy existing inventory and to pay damages in an amount to be determined.

An opposition to the EP ‘488 patent in the European Patent Office by Samsung Bioepis and Biogen was rejected on 20 June 2024 by the Technical Board of Appeal.

Imraldi® received European regulatory approval in 2017 and was launched in Europe in October 2018 under a licence from AbbVie entered into in April 2018. It is known as Hadlima® in the US, where it is commercialised by Organon (approved July 2019, launched in July 2023).

Fresenius Kabi’s citrate-free adalimumab biosimilar, Idacio® was approved in Europe in 2019 and in the US in December 2022. It was launched in Europe in 2019 and in the US in July 2023.

IAM Patent 1000 Honours Pearce IP & 7 Leaders for 2025

Jun 13, 2025

Firm & 7 Leaders ranked in AU & NZ, for Patent Litigation & Prosecution

Pearce IP and 7 of its leaders have been ranked in Australia and New Zealand for patent litigation and prosecution by IAM Patent 1000 for 2025.

With consistent rankings for the Australian business year on year since 2020 (3 years after commencement of the firm), the New Zealand business has achieved ranking less than a year after incorporation.

Of the Australian business, IAM says:

“Dynamic and progressive”, Pearce IP is a “very impressive firm with a good culture that punches well above its weight. Comprising 27 “brilliant, business-savvy legal thinkers who are fast and thorough in their input,” the outfit is dedicated to serving the industry leaders of the life sciences and sustainable technology sectors.”

Of the New Zealand business incorporated in 2024 and launched earlier this year, IAM says:

“A smart and effective up and comer” Pearce IP’s New Zealand offering is “well regarded in the patent field, having attracted a number of subject-matter experts” proficient across the spectrum of contentious and non-contentious patent matters.”

We are also delighted for our leaders in Australia and New Zealand who have achieved personal rankings:

Australia: Founder and CEO Naomi Pearce (Gold in Litigation & Prosecution), Executive Helen Macpherson (Silver in Litigation & Transactions), Special Counsel Jacinta Flattery O’Brien (Silver in Prosecution), Special Counsel Chantal Savage (Recommended for Litigation); and Special Counsel Rosie Stramandinoli (Bronze in Prosecution & Transactions); and
New Zealand: Executives Julie Ballance (Silver in Prosecution), and Paul Johns (Recommended for Litigation).

CEO and Founder Naomi Pearce says:

“I am thrilled to see the team at Pearce IP honoured by IAM in the 2025 rankings. The teams are led by driven, talented, committed IP professionals who consistently set the standard for excellence in the provision of legal/IP services, and they deserve this honour.

I am particularly proud of the New Zealand business achieving ranking within its first 12 months of operation. This is a sign of the quality of the team, which continues to grow and makes waves in the New Zealand market.”

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the pharmaceutical, biopharmaceutical and life sciences industries. 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. Pearce IP leaders are well recognised as leading IP practitioners.

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, Women in Law Awards – Partner of the Year, Best Lawyers and Australasian Lawyer 5 Star Awards, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

New Indication Alert: FDA Expands Indications for Celltrion’s, Pfizer’s and Amgen’s Rituximab Biosimilars

Jun 12, 2025

On 12 June 2025, Celltrion, Amgen and Pfizer each received FDA approval of an additional indication for their rituximab biosimilars (Truxima®, Riabni® and Ruxience®, respectively), for treatment of moderate to severe pemphigus vulgaris in adult patients.

With the new indication, Amgen’s Riabni® is now approved for all indications of Genentech/Biogen’s Rituxan®, while Celltrion’s Truxima® is approved for all of Rituxan®’s non-paediatric indications. Pfizer’s Ruxience® is the only biosimilar without full adult coverage, missing both chronic lymphocytic leukemia and rheumatoid arthritis.

Rituximab was one of the first mAbs to become “biosimilar”, being first approved in the US on 26 November 1997. Truxima®, Riabni® and Ruxience® are currently the only three rituximab biosimilars approved in the US market, with Dr Reddy’s rituximab biosimilar being knocked back by the FDA in April 2024.

New Indication Alert: MSD’s Keytruda® (Pembrolizumab) FDA-Approved For Perioperative Treatment for HNSCC

Jun 12, 2025

On 12 June 2025, the US FDA announced that it has approved MSD’s Keytruda® (pembrolizumab) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 as determined by an FDA-approved test. Keytruda® is approved as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin after surgery, and then as a single agent. The approval comes in advance of the 23 June 2025 target action date assigned when the sBLA was accepted by the FDA for priority review in February 2025.

The FDA’s review of MSD’s sBLA was conducted under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that provides a framework for the collaborative review of new cancer treatments among international regulatory partners. Keytruda® is currently under evaluation in Australia for the same HNSCC indication and regulatory authorities in Brazil, Canada, Israel and Switzerland are also reviewing the application.

The new indication approval comes days after it was reported by Fierce Pharma that the FDA has narrowed the label for Keytruda® (and Opdivo® (nivolumab)) in gastric, gastroesophageal junction and oesophageal cancers to only those patients whose tumours express PD-L1. The limitation for Keytruda® applies to HER2-negative disease as the indication relating to HER2-positive disease had already been limited to PD-L1 positive tumours in November 2023.

Xbrane Partners with OneSource for Biosimilar Manufacturing

Jun 11, 2025

On 11 June 2025, Sweden-based Xbrane Biopharma and OneSource Specialty Pharma, an Indian-based CDMO, announced that they have entered a partnership for the commercial manufacture of Xbrane’s biosimilar portfolio.

Xbrane’s biosimilars include Ximluci®, biosimilar to Genentech’s Lucentis® (ranibizumab), which was launched by Xbrane and STADA in Europe in April 2023. On 21 April 2024, the FDA issued a Complete Letter Response regarding Xbrane’s ranibizumab BLA. Xbrane resubmitted its BLA to the FDA in December 2024.

The manufacturing partnership between Xbrane and OneSource closely follows completion of Alvotech’s acquisition of Xbrane’s Swedish R&D operations, as well as XB003, biosimilar to UCB’s Cimzia® (certolizumab pegol), in a deal worth US$28.9m.

Pearce IP BioBlast® for the week ending 6 June 2025

Jun 10, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 6 June 2025 are set out below:

Bevacizumab

2 June 2025 | UK | DE | Outlook Therapeutics Launches Ophthalmic Bevacizumab in UK and Germany

On 2 June 2025, Outlook Therapeutics announced that it has launched Lytenava™ (bevacizumab gamma) in the UK and Germany, for the treatment of nAMD. Lytenava™ is the first and only… Read more here.

Certolizumab Pegol

4 June 2025 | Alvotech Completes US$28.9M Acquisition of Xbrane’s Swedish R&D Operations & Biosimilar Certolizumab Pegol

On 4 June 2025, Alvotech announced that it has completed the acquisition of Xbrane’s Swedish R&D operations, as well as XB003, biosimilar to UCB’s Cimzia® (certolizumab pegol), in a deal worth… Read more here.

Pembrolizumab

5 June 2025 | Alvotech and Dr Reddy’s Partner on Biosimilar to Keytruda® (Pembrolizumab)

On 5 June 2025, Alvotech and Dr Reddy’s announced that they have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to MSD’s Keytruda® (pembrolizumab)… Read more here.

Ranibizumab

5 June 2025 | BR | Formycon’s Ranibizumab Biosimilar Approved in Brazil

On 5 June 2025, Formycon announced that Brazil’s ANVISA has granted marketing authorisation for Ranivisio® (FYB201), biosimilar to Genentech’s Lucentis® (ranibizumab)… Read more here.

Tocilizumab

2 June 2025 | KR | Celltrion Launches Tocilizumab Biosimilar in Korea

On 2 June 2025, ChosunBiz reported that Celltrion has launched Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in Korea. Avtozma® was approved by Korea’s Ministry of Food and Drug Safety… Read more here.

Ustekinumab

9 June 2025 | EU | Celltrion’s Second Ustekinumab Biosimilar Approved in EU

On 9 June 2025, Celltrion announced that its Qoyvolma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) has received marketing approval from the European Commission (EC). Qoyvolma® is… Read more here.

27 May 2025 | CA | Formycon & Fresenius Launch Biosimilar Ustekinumab in Canada

On 27 May 2025, Formycon and Fresenius Kabi announced the Canadian launch of FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). The biosimilar is available in both IV and… Read more here.

Biosimilar Policy

4 June 2025 | AU | New Sandoz White Paper Proposes Australian Biosimilar Policy Reforms

On 4 June 2025, Sandoz Australia published a white paper entitled “Pioneering Access for Patients Through Biosimilar Medicines” which outlines proposals for reducing healthcare costs and expanding… 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.

Outlook Therapeutics’ Ophthalmic Bevacizumab Accepted for Use Within NHS Scotland

Jun 10, 2025

On 10 June 2025, Outlook Therapeutics announced that the Scottish Medicines Consortium has accepted Lytenava™ (bevacizumab gamma) for use within NHS Scotland for the treatment of wet AMD.

Earlier this month, Outlook Therapeutics announced that it had launched Lytenava™ in the UK and Germany for wet AMD. Lytenava™ is the first and only licensed ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the UK.

Lytenava™ (also known as ONS-5010, bevacizumab-vikg/bevacizumab gamma) 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.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD in March 2025.

Samsung Bioepis Successful in Federal Court Action to Revoke 3 AU Janssen Ustekinumab Patents

Jun 9, 2025

On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016). The Court’s revocation orders, made before the scheduled end of the trial, bring to a conclusion the patent infringement proceedings commenced by Janssen Biotech (and Janssen-Cilag Pty Ltd) against Samsung Bioepis in August 2024. The Janssen innovation patents all related to a method of treating ulcerative colitis with ustekinumab. The Court is yet to issue any reasons for judgment in these proceedings.

This is a second victory for Samsung Bioepis in Australia with the earlier January 2024 Federal Court of Australia patent proceeding concluding with Janssen surrendering the two innovation patents in suit. These innovation patents again related to a method of treating ulcerative colitis with ustekinumab.

Samsung Bioepis’ ustekinumab biosimilar, Epyztek®, was approved in Australia in October 2024. Other ustekinumab biosimilars approved in Australia are Celltrion’s SteQeyma®/CT-P43 (September 2024) and Amgen’s Ajemnye® (May 2024) and Wezlana® (January 2024).

Janssen’s Stelara® remains the only PBS-listed ustekinumab product at this stage. Amgen’s Wezlana® was recommended for listing at the March 2024 PBAC meeting, but the company has advised that it is not proceeding in the PBS listing process at this time. Celltrion’s SteQeyma® was recommended for PBS-listing at PBAC’s November 2024 meeting and Samsung Bioepis’ Epyztek® was recommended for PBS-listing at PBAC’s March 2025 meeting.

Samsung Bioepis Partners with Japan’s NIPRO for Biosims Including Ustekinumab

Jun 9, 2025

On 9 June 2025, Samsung Bioepis announced that it has entered into a partnership agreement with NIPRO Corporation in Japan for multiple biosimilars, including SB17, Samsung Bioepis’ biosimilar to Janssen’s Stelara® (ustekinumab).

Under the terms of the agreement, Samsung Bioepis is responsible for the development, manufacture and supply of the biosimilars, with NIPRO responsible for their commercialisation in Japan.

This follows Biocon Biologic’s announcement on 21 May 2025, that its commercial partner, Yoshindo, launched Ustekinumab BS Subcutaneous Injection in Japan for the treatment of psoriasis vulgaris and psoriatic arthritis. In September 2023, Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, had received marketing approval for AVT04 (ustekinumab) from the Japanese Ministry of Health, Labor and Welfare.

PTAB Invalidates Johns Hopkins’ US Pembrolizumab MOT Patent in MSD’s IPR

Jun 9, 2025

On 9 June 2025, the US Patent Trial and Appeal Board issued a written decision invalidating all claims of Johns Hopkins University’s US Patent No. 11,591,393 on the basis of anticipation and obviousness. US Patent No. 11,591,393 is directed to treating patients with microsatellite instable (MSI) or DNA mismatch repair deficient (dMMR) colorectal cancer with pembrolizumab. The decision was issued in proceedings for inter partes review (IPR) filed by MSD on 20 November 2021 (IPR2024-240).

The following IPRs commenced by MSD in relation to Johns Hopkins University (JHU) patents relating to pembrolizumab remain pending:

11,649,287 (IPR2024-00647), 11,629,187 (IPR2024-00649), and 11,634,491 (IPR2024-00650): petitions filed on 13 March 2024, IPRs instituted on 27 September 2024;
10,934,356 (IPR2024-00622), 11,325,974 (IPR2024-00623), 11,325,975 (IPR2024-00624) and 11,339,219 (IPR2024-00625): petitions filed on 4 March 2024, IPRs instituted on 23 September 2024;
11,591,393 (IPR2024-240): petition filed on 30 November 2023, IPR instituted 13 June 2024; and
11,643,462 (IPR2024-00648): petition filed 13 March 2024, IPR instituted 3 October 2024.

In November 2022, MSD filed a complaint in the United States District Court (District of Maryland) against JHU seeking declarations of breach of contract, non-infringement and promissory estoppel. Based on the complaint, the dispute arose out of a contract between MSD and the University to design and conduct a clinical trial on administration regimes for Keytruda® (pembrolizumab) in cancer patients with certain genetic biomarkers. JHU filed a counter-claim on 12 April 2023, including alleging infringement of each of the patents subject to the IPR proceedings referred to above. The US Court proceeding has been stayed pending the outcome of the IPRs. No trial date has been scheduled.

Celltrion’s Second Ustekinumab Biosimilar Approved in EU

Jun 9, 2025

On 9 June 2025, Celltrion announced that its Qoyvolma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) has received marketing approval from the European Commission (EC). Qoyvolma® is Celltrion’s second European ustekinumab biosimilar, following Steqeyma®, which was approved by the EC in August 2024 and launched in the EU in November 2024.

Qoyvolma® received a positive opinion from the EMA’s CHMP in March 2025. It has been approved with an additional indication to that of Steqeyma®, with moderately to severely active ulcerative colitis in adults included in its list of indications, together with adult and paediatric plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease.

There are a number of ustekinumab biosimilars now marketed in the EU, with STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® launched in July 2024. Approved ustekinumab biosimilars in Europe include Biocon’s Yesintek® (February 2025), Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).

Formycon’s Ranibizumab Biosimilar Approved in Brazil

Jun 5, 2025

On 5 June 2025, Formycon announced that Brazil’s ANVISA has granted marketing authorisation for Ranivisio® (FYB201), biosimilar to Genentech’s Lucentis® (ranibizumab).

Formycon expects that Ranivisio® will be launched in Brazil in Q4 2025 by its commercialisation partner, Biomm, with a phased market rollout of Ranivisio® to follow across Latin America. Marketing authorisations have previously been granted in Peru, El Salvador, Honduras and the Dominican Republic and further approvals in Central and South America are planned.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics). It has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), the EU (in August 2022, marketed as Ranivisio® by Teva), Canada (in December 2023, marketed as Ranopto™ by Teva) and MENA (marketed as Ravegza® by MS Pharma).

Alvotech and Dr Reddy’s Partner on Biosimilar to Keytruda® (Pembrolizumab)

Jun 5, 2025

On 5 June 2025, Alvotech and Dr Reddy’s announced that they have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to MSD’s Keytruda® (pembrolizumab).

Under the agreement, Alvotech and Dr Reddy’s will be jointly responsible for developing and manufacturing the pembrolizumab biosimilar and will share all costs and responsibilities. Subject to certain undisclosed exceptions, each company will have the right to commercialise the product globally.

There are a number of pembrolizumab biosimilars already in clinical trials, including Formycon’s FYB206 (Ph 1 commenced June 2024 in malignant melanoma), Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024), Bio-Thera’s BAT3306 (Ph 1/3 in nsNSCLC commenced in 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 commenced in May 2024). In September 2024, Shanghai Henlius Biotech received approval in China for a clinical trial of its pembrolizumab biosimilar, HLX17.

New Sandoz White Paper Proposes Australian Biosimilar Policy Reforms

Jun 4, 2025

On 4 June 2025, Sandoz Australia published a white paper entitled “Pioneering Access for Patients Through Biosimilar Medicines” which outlines proposals for reducing healthcare costs and expanding patient access to biosimilars in Australia. The white paper is the outcome of a summit of stakeholders held in Canberra, Australia on 10 February 2025.

Noting that “Australia is behind most of its international counterparts in biosimilar uptake in retail pharmacies”, the white paper sets out four key policy proposals explored at the February summit:

lowering patient co-payments for biosimilars;
mandating biosimilars for new, treatment naïve patients;
reducing administrative burdens for clinicians (e.g. removing Pharmaceutical Benefits Scheme (PBS) authority requirements once biosimilar uptake surpasses 70%); and
reinvesting savings from increased biosimilar uptake into a chronic disease future fund.

The white paper suggests that such policy reforms could result in greater affordability and access to medicines for patients, increased competition and PBS savings, reduced prescribing complexity for healthcare professionals and more sustainable funding for new medicines and long-term health priorities.

Alvotech Completes US$28.9M Acquisition of Xbrane’s Swedish R&D Operations & Biosimilar Certolizumab Pegol

Jun 4, 2025

On 4 June 2025, Alvotech announced that it has completed the acquisition of Xbrane’s Swedish R&D operations, as well as XB003, biosimilar to UCB’s Cimzia® (certolizumab pegol), in a deal worth US$28.9m. The deal was initially announced by Alvotech in March 2025, and was approved by Xbrane’s board on 14 April 2025.

The acquisition comes a week after Alvotech expanded its partnership with Advanz Pharma to cover three additional biosimilar candidates in Europe. The products covered by the agreement are biosimilars to Novartis’ Ilaris® (canakinumab) and Kesimpta® (ofatumumab), and a third, undisclosed early-stage biosimilar.

Pearce IP BioBlast® for the fortnight ending 30 May 2025

Jun 3, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the fortnight ending 30 May 2025 are set out below:

Adalimumab

27 May 2025 | US | Samsung Bioepis’ and Celltrion’s Adalimumab Biosimilars Granted Expanded US Interchangeability

On 27 May 2025, Samsung Bioepis announced that it has secured expanded interchangeability designation in the US for its Hadlima™ (adalimumab-aaty), biosimilar to AbbVie’s Humira®, in high- and low-concentration… Read more here.

Aflibercept

27 May 2025 | AU | Approval Alert: Sandoz’s Aflibercept Biosimilars Second to be Approved in Australia

On 27 May 2025, Sandoz’s Afqlir® and Enzeevu®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept 2mg), were approved by Australia’s Therapeutic Good’s Administration (TGA) across 4 products… Read more here.

23 May 2025 | CN | EU | Regeneron/Bayer’s Aflibercept 8mg Recommended in EU with Expanded Treatment Interval and Approved in China

On 23 May 2025, Bayer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a label extension for Eylea™ 8mg (aflibercept… Read more here.

Canakinumab, Ofatumumab

28 May 2025 | EU | Alvotech & Advanz Pharma Expand Partnership to 3 New Biosimilars, Including Canakinumab & Ofatumumab

On 28 May 2025, Alvotech and Advanz Pharma announced that they have entered a supply and commercialisation agreement to expand their existing partnership to cover three additional biosimilar candidates… Read more here.

Denosumab

2 June 2025 | US | Sandoz Launches First Denosumab Biosimilars in US

On 2 June 2025, Sandoz announced its US launch of Wyost® and Jubbonti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab), respectively. Wyost® and Jubbonti® are the first and only… Read more here.

30 May 2025 | KR | Approval Alert: Samsung Bioepis’ Second Denosumab Biosimilar Approved in South Korea

On 30 May 2025, Samsung Bioepis announced that it has received marketing approval in South Korea for its second denosumab biosimilar, Xbryk™, biosimilar to Amgen’s Xgeva® (denosumab)… Read more here.

28 May 2025 | US | Cytiva Subsidiary Seeks to Quash Subpoena Issued in Amgen’s US Denosumab Litigation Against Accord & Intas

Three months after Cytiva subsidiary media supplier HyClone Laboratories filed a motion to quash a subpoena issued to it by Amgen in the context of denosumab BPCIA litigation between Amgen and Fresenius Kabi… Read more here.

22 May 2025 | EU | CHMP Recommends Approval of Denosumab Biosimilars for Fresenius & Sandoz

At its May 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three denosumab biosimilars: Sandoz’s Rolcya®… Read more here.

Eculizumab

21 May 2025 | UK | Alexion Fails in UK Infringement Actions Against Samsung Bioepis’ & Amgen’s Eculizumab Biosimilars

On 21 May 2025, Mr Justice Meade of the High Court of Justice for England and Wales delivered his decision in proceedings involving allegations of patent infringement by Alexion against each of Samsung Bioepis and Amgen… Read more here.

Mepolizumab

22 May 2025 | US | GSK’s Nucala® (Mepolizumab) FDA Approved for COPD

On 22 May 2025, GSK announced that the US FDA has approved Nucala® (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic… Read more here.

Nivolumab

28 May 2025 | EU | CA | BMS’ Subcutaneous Opdivo® (Nivolumab) EU and CA Approved

On 27 and 28 May 2025, Bristol Myers Squibb announced that its subcutaneous formulation of Opdivo® (nivolumab), Opdivo® SC (nivolumab co-formulated with recombinant human… Read more here.

Pertuzumab

28 May 2025 | RU | Biocad’s Pertuzumab Biosimilar Approved in Russia

On 28 May 2025, Russia’s GxP News reported that the Russian Ministry of Health approved Russian biotechnology company Biocad’s Pertuvia™, biosimilar to Roche’s Perjeta® (pertuzumab), making it… Read more here.

Tocilizumab

30 May 2025 | AU | Approval Alert: Celltrion’s Avtozma® First Biosimilar Tocilizumab Approved in Australia

On 30 May 2025, Australia’s Therapeutic Good’s Administration (TGA) approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), across 5 products… Read more here.

Ustekinumab

27 May 2025 | US | Bio-Thera/Hikma’s Biosimilar Ustekinumab Approved in US

On 27 May 2025, Bio-Thera Solutions and Hikma Pharmaceuticals announced that the US FDA has approved BAT2206, marketed as Starjemza® (ustekinumab-hmny), biosimilar to J&J/Janssen’s… Read more here.

25 May 2025 | UK | Biocon’s Biosimilar Ustekinumab UK Approved

On 25 May 2025, Biocon Biologics announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Yesintek®, biosimilar to… Read more here.

21 May 2025 | EU | Sandoz Launches First Biosimilar Ustekinumab Autoinjector in Europe

On 21 May 2025, Sandoz announced the launch of its Pyzchiva® autoinjector as the first commercially available biosimilar ustekinumab pre-filled pen in Europe. The autoinjector is currently… Read more here.

21 May 2025 | JP | Biocon/Yoshindo Launch Subcutaneous Biosimilar Ustekinumab in Japan

On 21 May 2025, Biocon Biologics announced that Yoshindo, its commercial partner, has launched Ustekinumab BS Subcutaneous Injection in Japan for treatment of psoriasis vulgaris and psoriatic… Read more here.

19 May 2025 | US | Formycon/Fresenius Secure US Interchangeability for Biosimilar Ustekinumab

On 19 May 2025, Formycon and Fresenius Kabi announced that the US FDA has designated FYB202/Otulfi® (ustekinumab-aauz) as interchangeable with J&J/Janssen’s Stelara® (ustekinumab) in… 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.

Approval Alert: Biocon’s Generic Liraglutide Approved in India

Jun 2, 2025

On 2 June 2025, Biocon announced that its generic liraglutide has been approved by India’s Central Drugs Standard Control Organisation (CDSCO) in 6 mg/ml solution for injection in pre-filled pen and cartridge.

Biocon’s liraglutide, the generic version of Novo Nordisk’s Victoza®, is indicated for the treatment of insufficiently controlled Type 2 diabetes mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise. The CDSCO approved Biocon’s liraglutide under the recently formulated 101 route that enables recognition of approvals granted by established and referenced serious regulatory authorities.

Biocon’s liraglutide was the first generic to Victoza® to be approved in the UK in March 2024, and was subsequently launched in February 2025. In December 2024, Biocon and its European partner, Zentiva, received approval for liraglutide in the European Union. The first EU-approved generic liraglutide was Adalvo’s liraglutide pre-filled pen in June 2024. Teva Pharmaceuticals launched the first authorised generic version of Victoza® in the US in June 2024.

Celltrion Launches Tocilizumab Biosimilar in Korea

Jun 2, 2025

On 2 June 2025, ChosunBiz reported that Celltrion has launched Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in Korea. Avtozma® was approved by Korea’s Ministry of Food and Drug Safety in December 2024 for the same indications as Actemra®.

Just a few days earlier, the Therapeutic Good’s Administration (TGA) approved Avtozma® as the first tocilizumab biosimilar in Australia.

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024. Avtozma® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

Outlook Therapeutics Launches Ophthalmic Bevacizumab in UK and Germany

Jun 2, 2025

On 2 June 2025, Outlook Therapeutics announced that it has launched Lytenava™ (bevacizumab gamma) in the UK and Germany, for the treatment of nAMD. Lytenava™ is the first and only authorised ophthalmic formulation of bevacizumab in the EU and UK.

Lytenava™ (ONS-5010, bevacizumab-vikg/bevacizumab gamma) 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.

Outlook Therapeutics has entered into a strategic collaboration with Cencora in relation to the commercial launch of Lytenava™ globally. In Europe, Cencora provides launch support including pharmacovigilance, regulatory affairs, quality management, market access support, importation, third-party logistics, distribution and field solutions.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD in March 2025.

Biosimilars Deals 2021

Bevacizumab

Pembrolizumab

Rituximab

Ustekinumab

Biopharma Deals

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

About Pearce IP

About Pearce IP

Firm & 7 Leaders ranked in AU & NZ, for Patent Litigation & Prosecution

About Pearce IP

Bevacizumab

Certolizumab Pegol

Pembrolizumab

Ranibizumab

Tocilizumab

Ustekinumab

Biosimilar Policy

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

Adalimumab

Aflibercept

Canakinumab, Ofatumumab

Denosumab

Eculizumab

Mepolizumab

Nivolumab

Pertuzumab

Tocilizumab

Ustekinumab

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

Product specific reports based on extracts from our BioBlast® database

Biosimilars Deals

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