Biosimilars Deals 2021 Archives | Page 3 of 8

Bayer’s Eylea™ 8mg EU Approved with Extended Treatment Intervals in nAMD and DME

Jun 27, 2025

On 27 June 2025, Bayer announced that the European Commission has granted a label extension for Eylea™ 8mg (aflibercept, 114.3mg/ml solution for injection) with extended treatment intervals of up to 6 months for the treatment of nAMD and visual impairment due to diabetic macular oedema (DME).

This news comes just over a month after the label extension was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in May 2025.

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

Eylea™ 8 mg (aflibercept 8 mg) has been approved to date in more than 60 markets for the treatment of nAMD and DME. Regeneron/Bayer have recently submitted marketing authorisation applications for Eylea™ 8mg for the treatment of patients with macular oedema following retinal vein occlusion (RVO) in Japan (May 2025), Europe (April 2025) and the US (application accepted by FDA for priority review in April 2025, with a target action date of 19 August 2025).

Biocon’s Yesafili™ is First Approved Aflibercept Biosimilar in Canada; July 2025 Launch Planned

Jun 27, 2025

On 27 June 2025, Biocon Biologics announced that Yesafili™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg) has been approved by Health Canada in vial and PFS presentations, becoming the first aflibercept biosimilar approved in Canada. It is indicated for nAMD, visual impairment due to macular oedema secondary to RVO, diabetic macular oedema (DME) and myopic CNV.

The Canadian launch of Yesafili™ is planned for 4 July 2025, as a result of a March 2024 settlement between Biocon and Regeneron/Bayer. The July 2025 Canadian launch will be the first launch of Yesafili™ worldwide. Amgen’s Pavblu™ (aflibercept) was launched in the US in October 2024.

Yesafili™ was the first aflibercept biosimilar approved in Europe in September 2023 (where it is not yet launched). In the US, both Yesafili™ and Samsung Bioepis’ Opuviz®, were the first approved interchangeable aflibercept biosimilars in May 2024. Biocon and Regeneron settled US BPCIA litigation regarding aflibercept in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026, or earlier under certain undisclosed circumstances.

Formycon and Teva Join Forces on Ustekinumab Biosimilar in Germany

Jun 26, 2025

On 26 June 2025, Formycon announced that it has entered into a non-exclusive distribution agreement with Teva Group’s subsidiary, Ratiopharm GmbH, to commercialise FYB202/Fymskina®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Germany. German launch of Fymskina® is planned for Q3 2025.

Under the agreement, which follows the European Commission’s approval of Fymskina®/FYB202 in September 2024, Formycon is responsible for manufacture and supply, and Ratiopharm is responsible for commercialisation.

Formycon entered into a global commercialisation partnership for FYB202 with Fresenius Kabi in February 2023, in which Formycon retained secondary commercialisation rights for Germany, parts of Latin America, and the MENA region. Pursuant to the global commercialisation agreement, Formycon and Fresenius Kabi launched FYB202 (marketed as Otulfi®) in Canada in May 2025 and in the US in March 2025 (securing US interchangeability for FYB202 in May 2025). Formycon also separately entered into a licence/supply agreement with MS Pharma for countries in the MENA region in December 2024.

Novo Nordisk’s Wegovy® (Semaglutide) Set for July New Zealand Launch

Jun 26, 2025

On 26 June 2025, New Zealand Doctor reported that Novo Nordisk is set to launch Wegovy® (semaglutide) in New Zealand from 1 July 2025.

New Zealand’s Medsafe approved Wegovy® in March 2025 for two indications:

an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults and adolescents aged 12 years and above; and
as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (MACE) in adults with established cardiovascular disease (CVD) without established Type 1 or Type 2 diabetes.

Semaglutide was first approved in New Zealand as Ozempic® in March 2023, indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.

Wegovy® was launched in Australia in August 2024, following its approval in September 2022 for weight management. In December 2024, Australia’s Therapeutic Goods Administration (TGA) approved an indication extension for Wegovy® to reduce the risk of MACE in overweight and obese adults with established CVD and without established Type 1 or Type 2 diabetes.

Amgen Sues Hikma/Richter and Shanghai Henlius/Organon Over US Denosumab Biosimilars

Jun 26, 2025

On 25 June 2025, Amgen filed BPCIA litigation in the US District Court for the District of New Jersey against Hikma Pharmaceuticals/Gedeon Richter and Shanghai Henlius Biotech/Organon, asserting infringement of multiple US patents (32 for Hikma/Richter and 26 for Henlius/Organon) covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.

The litigation follows the FDA’s acceptance in December 2024 of Richter/Hikma’s BLA for RGB-14-P and RGB-14-X, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab). Under an exclusive licence agreement entered in December 2021, Gedeon Richter is responsible for the development of RGB-14, while Hikma is responsible for FDA registration and has exclusive rights to commercialise it in the US following approval.

Organon and Shanghai Helius’ BLA for HLX14 (denosumab) was accepted for review by the FDA in October 2024. In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 (and pertuzumab, HLX11) under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.

The complaints against Hikma/Richter and Henlius/Organon represent the 6^th and 7^th BPCIA suits filed by Amgen in the US in relation to alleged patent infringement concerning denosumab biosimilars. However, Amgen has settled three of its US denosumab disputes over the last 18 months. A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, in the US from 31 May 2025. Amgen settled its US litigation against Celltrion in January 2025, permitting US launch of Celltrion’s denosumab biosimilar, CT-P41, from 1 June 2025. In March 2025, Amgen entered into a global settlement of its patent infringement litigation in relation to Fresenius Kabi’s denosumab biosimilar, allowing US launch of Fresenius’ biosimilar in mid-2025. Amgen’s BPCIA litigation against Accord/Intas and Samsung Bioepis regarding their denosumab biosimilars remains pending.

Bio-Thera Partners with SteinCares to Commercialise Dupilumab Biosimilar in LATAM

Jun 25, 2025

On 25 June 2025, Bio-Thera Solutions, Ltd. and Costa Rican-based SteinCares announced that they have signed an agreement to commercialise biosimilar dupilumab across Latin America. Under the agreement, Bio-Thera will be responsible for product development and supply, while SteinCares will lead the registration and commercialisation process throughout Latin America.

Bio-Thera’s BAT2406, biosimilar to Sanofi’s Dupixent® (dupilumab), is currently undergoing Phase I clinical trials.

This is the fourth product on which the companies have agreed to collaborate in the region. An agreement was announced in March 2024 in relation to BAT2606, biosimilar to GSK’s Nucala® (mepolizumab) and BAT2506, biosimilar to J&J’s Simponi® and Simponi Aria® (golimumab). The partnership was expanded in December 2024 to include a third undisclosed product.

Formycon/Klinge and Valorum Partner for US Commercialisation of Aflibercept Biosimilar

Jun 25, 2025

On 25 June 2025, Formycon announced that Klinge Biopharma, its exclusive global licensee of FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2 mg), has entered an exclusive licence agreement with Valorum Biologics for commercialisation of FYB203 in the US and Canada.

Under the agreement, Klinge will receive royalties on net sales and is eligible to receive upfront and milestone payments, with Formycon receiving a single to low double-digit percentage of those payment streams. Formycon will additionally receive service payments and a volume-based profit component for organising the commercial market supply on behalf of Klinge.

FYB203 was approved in the US in June 2024, where it is currently subject to a preliminary injunction granted in June 2024, and upheld at the end of January 2025, resulting from a patent infringement proceeding brought by Regeneron in November 2023.

The only aflibercept biosimilar to have launched in the US is Amgen’s Pavblu™, which launched in October 2024 following the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar. Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (June 2025), which is pending.

Formycon developed FYB203 and Klinge holds the exclusive global commercialisation rights. In mid-January 2025, Formycon/Klinge and Teva Pharmaceuticals entered a collaboration agreement for the semi-exclusive commercialisation of FYB203 in Europe (excluding Italy) and Israel. FYB203 received approval from the European Medicines Agency (EMA) in January 2025, under the brand names Ahzantive® and Baiama®, and from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in February 2025.

In May 2024, Valorum partnered with Xbrane and STADA in relation to their ranibizumab biosimilar, which has not yet been approved in the US.

Pearce IP BioBlast® for the week ending 20 June 2025

Jun 24, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 20 June 2025 are set out below:

Adalimumab

16 June 2025 | DE | German Court Rules Samsung Bioepis/Biogen’s Adalimumab Biosimilar Infringes Fresenius Formulation Patent

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… Read more here.

Aflibercept

23 June 2025 | AU | Regeneron & Bayer Seek Interlocutory Injunction to Prevent AU Launch of Sandoz’s Aflibercept Biosimilar

On 4 June 2025, Regeneron and Bayer filed proceedings against Sandoz in the Australian Federal Court alleging infringement of Regeneron’s AU2012205599 relating to methods of treatment for… Read more here.

17 June 2025 | US | Regeneron Files New US BPCIA Complaint Against Amgen for Pavblu™, Eylea® Biosimilar

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)… Read more here.

Aflibercept, Ustekinumab

20 June 2025 | EU | Positive CHMP Opinions for Four Aflibercept Biosimilars, and One Ustekinumab Biosim

On 20 June 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcome of its June meeting, with positive opinions for aflibercept biosimilars… Read more here.

Clesrovimab, Mepolizumab

19 June 2025 | AU | MSD’s Clesrovimab Accepted for Review Alongside Expanded Indication for GSK’s Nucala® (Mepolizumab)

On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for March, April and May 2025… Read more here.

Eculizumab

19 June 2025 | EU | UPC Court of Appeal Refuses Rehearing in Alexion’s Eculizumab Patent Infringement Actions Against Samsung Bioepis and Amgen

On 19 June 2025, the Unified Patent Court (UPC) Court of Appeal issued decisions refusing two rehearing applications by Alexion Pharmaceuticals in proceedings it had brought seeking preliminary… Read more here.

Nivolumab, Ipilimumab, Omalizumab

20 June 2025 | AU | Australia’s PBAC Recommends Reimbursement of BMS’ Opdivo®/Yervoy® Combo for Stage III Melanoma; Novartis’ Xolair® Recommended for CRSwNP

On 20 June 2025, Australia’s Pharmaceutical Benefits Scheme (PBS) published its outcomes from the May 2025 PBAC intracycle meeting, with BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab)… Read more here.

Ustekinumab, Etanercept, Natalizumab

20 June 2025 | AU | Ustekinumab, Etanercept and Natalizumab Biosimilars Up for July PBS-Listing

Several biosimilars are positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 July 2025, namely: Celltrion’s Steqeyma® (ustekinumab, biosimilar to 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

Lawyer

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

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

Biocon Partners with Malaysia’s National Cancer Society for Supply of Oncology Biosimilars

Jun 24, 2025

On 24 June 2025, Biocon Biologics announced it has partnered with the National Cancer Society of Malaysia (NCSM), a non-for-profit organisation, to launch a Patient Assistance Program advocating for the accessibility and affordability of biosimilars. Biocon intends to supply the NCSM with a range of biosimilars from its oncology portfolio, including trastuzumab, pegfilgrastim and bevacizumab. The program will commence with provision of bTrastuzumab to cancer patients currently facing treatment delays due to budget constraints.

In the US, Biocon’s oncology franchise includes Ogivri® (biosimilar trastuzumab, launched in December 2019), Fulphila® (biosimilar pegfilgrastim, approved June 2018) and Jobevne™ (biosimilar bevacizumab, approved April 2025).

New Indication Alert: Ono/BMS’ Opdivo®/Yervoy® Combo Approved for Unresectable Hepatocellular Carcinoma in Japan

Jun 24, 2025

On 24 June 2025, Ono Pharmaceutical and BMS announced that they have received a supplemental approval for expanded use of Ono’s Opdivo® (nivolumab) and BMS’ Yervoy® (ipilimumab) in combination for the treatment of unresectable hepatocellular carcinoma (HCC). The approval comes almost a year after the companies submitted the supplemental application in August 2024.

The combination therapy has previously been approved for HCC in the US (April 2025) and EU (March 2025) and remains under consideration in Australia. In May 2025, Australia’s Therapeutic Goods Administration (TGA) approved the combination therapy for unresectable or metastatic colorectal cancer (CRC), and it was recommended for PBS-listing for stage III melanoma in June 2025.

Positive CHMP Opinion for Alvotech/Advanz’s Biosimilar Aflibercept

Jun 23, 2025

On 23 June 2025, Alvotech and Advanz Pharma announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AVT06, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg).

AVT06 is indicated for the treatment of adults with nAMD, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

Alvotech and Advanz Pharma entered into an agreement in relation to the European commercialisation of AVT06 in June 2024. Under the agreement, Advanz Pharma has exclusive commercialisation rights throughout Europe, except in Germany and France, where the rights are semi-exclusive. The agreement also covers Alvotech’s AVT29, biosimilar to high-dose (8mg) Eylea®.

There are currently seven aflibercept (2mg) biosimilars approved in Europe: Celltrion’s Eydenzelt® (February 2025), Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025) and Amgen’s Pavblu® (April 2025).

Amgen’s Skojoy® received a positive recommendation for marketing approval from the CHMP in January 2025 but the application was withdrawn in April 2025. A number of aflibercept (2mg) biosimilars are also awaiting European Commission approval, including STADA’s Afiveg®, Polpharma’s Eiyzey® and Vgenfli®, and Advanz Pharma’s Mynzepli® (positive CHMP opinions adopted in June 2025).

In February 2025, Alvotech’s AVT06 BLA was accepted in the US, where it is to be commercialised by Teva. Alvotech and Teva are expecting that regulatory approval from the FDA will be obtained in Q4 2025.

Regeneron & Bayer Seek Interlocutory Injunction to Prevent AU Launch of Sandoz’s Aflibercept Biosimilar

Jun 23, 2025

On 4 June 2025, Regeneron and Bayer filed proceedings against Sandoz in the Australian Federal Court alleging infringement of Regeneron’s AU2012205599 relating to methods of treatment for angiogenic eye disorders. Regeneron is seeking both an interlocutory injunction and final relief.

The first case management hearing in the proceeding was held on 23 June 2025, with Sandoz publicly confirming that it intends to PBS-list and launch Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in Australia from 1 December 2025. Sandoz does not presently intend to exploit its other ARTG-listed aflibercept biosimilar, Enzeevu®, in Australia during 2025.

Sandoz indicated at the case management hearing that it will be filing a cross-claim seeking to invalidate the AU599 patent, including for lack of novelty.

The hearing of Regeneron/Bayer’s interlocutory injunction application is scheduled for 14 August 2025.

FDA Approves Samsung Bioepis’ Unbranded Adalimumab Biosimilar

Jun 23, 2025

On 23 June 2025, the FDA approved Samsung Bioepis’ sBLA for an unbranded version of Hadlima® (adalimumab-bwwd), biosimilar to AbbVie’s Humira®.

Samsung Bioepis is not the first to offer an unbranded US adalimumab biosimilar, with the FDA approving Celltrion’s sBLA for unbranded Yuflyma® (adalimumab-aaty) in November 2023.

In May 2025, the FDA expanded interchangeability for Samsung Bioepis’ Hadlima® in high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe. In the same month, the FDA also granted Celltrion’s Yuflyma® expanded interchangeability to include prefilled syringe (40mg) and autoinjector (40mg and 80mg) presentations. According to the companies, both biosimilars are now fully interchangeable with AbbVie’s Humira®.

The first high-concentration biosimilar to AbbVie’s Humira® to receive an interchangeability designation was Alvotech and Teva’s Simlandi®, which was approved in February 2024.

Ustekinumab, Etanercept and Natalizumab Biosimilars Up for July PBS-Listing

Jun 20, 2025

Several biosimilars are positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 July 2025, namely: Celltrion’s Steqeyma® (ustekinumab, biosimilar to Janssen’s Stelara®), Viatris’ Nepexto® (etanercept, biosimilar to Pfizer’s Enbrel®), Sandoz’s Tyruko® (natalizumab, biosimilar to Biogen’s Tysabri®).

Celltrion’s Steqeyma® is set to become the first biosimilar to Janssen’s Stelara® (ustekinumab) to be listed on the PBS. The product has reached the final “government processes” stage, indicating that PBS-listing is imminent. Steqeyma® was recommended in December 2024 following its consideration at PBAC’s November 2024 meeting. Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for listing at the March 2024 PBAC meeting, however Amgen is not proceeding with the PBS-listing and the PBAC process has ceased. Samsung Bioepis’ Epyztek® was recommended for PBS-listing at PBAC’s March 2025 meeting, but remains in the earlier stages of application.

Viatris’ Nepexto® may soon become the second biosimilar to Pfizer’s Enbrel® (etanercept) subsidised under the PBS, also reaching the final “government processes” stage. Samsung Bioepis/Arrow Pharma’s Brenzys® was the first PBS-listed etanercept biosimilar in April 2017.

Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), is also approaching PBS listing, following its recommendation in PBAC’s March 2025 meeting and approval as the first and only natalizumab biosimilar in Australia (April 2025). Tyruko® was developed by Polpharma Biologics and, under a global commercialisation agreement with Sandoz reached in 2019, Sandoz has exclusive rights to commercialise and distribute the product in all markets.

Australia’s PBAC Recommends Reimbursement of BMS’ Opdivo®/Yervoy® Combo for Stage III Melanoma; Novartis’ Xolair® Recommended for CRSwNP

Jun 20, 2025

On 20 June 2025, Australia’s Pharmaceutical Benefits Scheme (PBS) published its outcomes from the May 2025 PBAC intracycle meeting, with BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) recommended for reimbursement for stage III melanoma and Novartis’ Xolair® (omalizumab) recommended for reimbursement for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP).

In July 2024, Zydus Life Sciences’ nivolumab biosimilar received approval from India’s Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), for locally advanced or metastatic non-small cell lung cancer. At least Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars under development. On 29 April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for a biosimilar to BMS’ Yervoy® (ipilimumab).

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar approved in Australia (November 2024), and was recommended for reimbursement at PBAC’s March 2025 meeting, though has not yet proceeded to PBS-listing. However, Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.

Positive CHMP Opinions for Four Aflibercept Biosimilars, and One Ustekinumab Biosim

Jun 20, 2025

On 20 June 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcome of its June meeting, with positive opinions for aflibercept biosimilars of STADA, Polpharma and Advanz Pharma, and Bio-Thera’s biosimilar ustekinumab.

STADA’s Afiveg®, Polpharma’s Eiyzey® and Vgenfli®, and Advanz Pharma’s Mynzepli®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept), were each recommended (as 40 mg/ml solution for injection in pre-filled syringes and vials) for treatment of nAMD and visual impairment due to macular oedema secondary to retinal vein occlusion/diabetic macular oedema (DME)/myopic choroidal neovascularisation.

There are currently seven aflibercept (2mg) biosimilars approved in Europe: Celltrion’s Eydenzelt® (February 2025), Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025) and Amgen’s Pavblu® (April 2025). Amgen’s Skojoy® received a positive recommendation for marketing approval from the CHMP in January 2025 but the application was withdrawn in April 2025.

Bio-Thera Solution’s Usympro® (BAT2206), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) also received a positive CHMP opinion, for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease. Bio-Thera and Gedeon Richter entered into a licence and commercialisation agreement for Usympro®/BAT2206 in October 2024, under which Bio-Thera is responsible for the development and manufacturing of the product while Richter has commercialisation rights for the EU, UK and Switzerland. BAT2206 was approved in the US in May 2025 where it is to be commercialised by Hikma Pharmaceuticals under the name Starjemza®.

A sixth biosimilar recommended by the CHMP at its June meeting was Biocon’s Vivlipeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim), to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy. The recommendation comes over 6 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.

Australasian Lawyer and NZ Lawyer Rank Pearce IP as 2025 Top Specialist Firm

Jun 20, 2025

Pearce IP one of 3 Privately Owned Firms Ranked

Today Pearce IP was named by Australasian Lawyer and NZ Lawyer as one of ANZ’s Top Specialist Firms 2025.

Pearce IP is one of only 3 privately owned IP specialist firms ranked in the 2025 list of Top Specialist Firms, with another 2 ranked IP firms operating from a publicly listed model.

Top Specialist Firms 2025 were selected based on:

strength of the matters handled by the firms;

longevity in the profession;

client service delivery approach; and

noteworthy achievements in meeting clients’ needs.

According to Australasian Lawyer and NZ Lawyer:

“To sustain their edge, the Top Specialist Firms of 2025 have embraced innovation, prioritised talent development and redefined value through experience rather than just expertise.”

Congratulations to the Pearce IP team and leaders for this recognition.