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Biosimilars Deals 2021

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Pearce IP BioBlast® for the fortnight ending 10 April 2026

Apr 14, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the fortnight ending 10 April 2026 are set out below:

Aflibercept

2 April 2026 | US | FDA Approves Extended Dosing Interval for Regeneron/Bayer’s Eylea HD®

On 2 April 2026, Regeneron announced that the FDA has approved an extended dosing interval for Eylea HD® (aflibercept 8mg, “high dose”) of up to every 20 weeks for patients… Read more here.

2 April 2026 | IN | Bayer Reduces Eylea® Price in India by 44%

On 2 April 2026, The Economic Times reported that Bayer has reduced the upfront cost of Eylea® (aflibercept, 2mg) in India by about 44% to expand the eligible patient pool… Read more here.

27 March 2026 | DE | Path Cleared for Sandoz’s Biosimilar Aflibercept in Germany After Regeneron/Bayer Withdraw PI Application

Regeneron and Bayer have withdrawn a preliminary injunction (PI) application against Sandoz in Germany in relation to Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea®… Read more here.

Bevacizumab

7 April 2026 | US | Outlook Therapeutics Submits Dispute Resolution Request to FDA For Ophthalmic Bevacizumab Following Regulatory Setbacks
On 7 April 2026, Outlook Therapeutics announced that it has submitted a formal dispute resolution request (FDRR) to the FDA following a Type A meeting in March 2026 in relation to… Read more here.

Denosumab

7 April 2026 | US | Biocon Launches Denosumab Biosimilars in US
On 7 April 2026, Biocon Limited announced that it has launched Bosaya™ and Aukelso™ (denosumab-kyqq), biosimilars to Amgen’s Prolia® and Xgeva®, respectively, in the US… Read more here.

7 April 2026 | CA | Apotex’s Denosumab Biosimilar Approved in Canada
On 7 April 2026, Apotex announced that Health Canada has approved Denoza™, biosimilar to Amgen’s Prolia® (denosumab), for all indications of the reference biologic. Sandoz’s… Read more here.

31 March 2026 | US | Henlius/Organon Settle US Denosumab Litigation with Amgen
Shanghai Henlius and Organon have settled US BPCIA litigation brought by Amgen in June 2025 in relation to their denosumab biosimilars, Bilprevda® and Bildyos® (HLX14), as… Read more here.

Denosumab, Omalizumab

30 March 2026 | US | EU | Teva’s Biosimilar Denosumab FDA-Approved & Biosimilar Omalizumab Applications Accepted for Review in US & EU
On 30 March 2026, Teva Pharmaceutical Industries announced that the FDA has approved Ponlimsi™, biosimilar to Amgen’s Prolia® (denosumab). At the same time, Teva also… Read more here.

Dupilumab

13 April 2026 | EU | New Indication Alert: Regeneron/Sanofi’s Dupixent® (Dupilumab) EU-Approved for Young Children with CSU
On 13 April 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the European Commission for the treatment of moderate-to-severe chronic… Read more here.

Golimumab

20 March 2026 | US | Accord, Intas & Bio-Thera File IPR Petitions Challenging 4 of Janssen’s US Golimumab Patents
On 20 March 2026, Accord BioPharma, Intas Pharmaceuticals and Bio-Thera Solutions together filed four petitions for Inter Partes Review of Janssen’s US patent numbers… Read more here.

Omalizumab

6 April 2026 | CuraTeQ Completes Ph 3 Biosimilar Omalizumab Trial

On 6 April 2026, Aurobindo’s wholly owned subsidiary, CuraTeQ Biologics, announced it has obtained positive top-line results from a Phase 3 study of BP11 (omalizumab, 300 mg)… Read more here.

30 March 2026 | KR | Celltrion Launches High Dose (300 mg) Biosimilar Omalizumab in Korea

On 30 March 2026, Celltrion announced that it launched its high dose (300 mg) Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, in Korea, as reported by… Read more here.

Pembrolizumab

2 April 2026 | EU | New Indication Alert: MSD’s Keytruda® Approved in EU for Ovarian Cancer

On 2 April 2026, MSD announced that the European Commission has approved Keytruda® (pembrolizumab) in combination with paclitaxel, with or without bevacizumab, for… Read more here.

Pertuzumab, Trastuzumab

1 & 10 April 2026 | CN | Henlius Secures Clinical Trial Approval for Biosimilar Pertuzumab/Trastuzumab Combo in China, Doses First Patient

On 1 April 2026, Shanghai Henlius Biotech announced that its Investigational New Drug (IND) application for HLX319, biosimilar to Genentech/Roche’s Phesgo® (Perjeta®… Read more here.

Ranibizumab

31 March 2026 | US | Xbrane Delays US Ranibizumab Biosimilar BLA Resubmission to April/May 2026

On 31 March 2026, Xbrane provided an update on the resubmission of its ranibizumab biosimilar BLA to the FDA following a Complete Response Letter (CRL) received in… Read more here.

Rituximab

9 April 2026 | CN | New Indication Alert: Shanghai Henlius’ Biosimilar Rituximab Approved in China for Two New Non-Hodgkin’s Lymphoma Indications

On 9 April 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has approved two new non-Hodgkin’s lymphoma indications… Read more here.

Semaglutide

10 April 2026 | US | Apotex’s Generic Ozempic® (Semaglutide) Secures First FDA Tentative Approval

On 10 April 2026, Apotex announced that it received the first US FDA Tentative Approval for its Abbreviated New Drug Application (ANDA) for Semaglutide Injection, a generic… Read more here.

Trastuzumab deruxtecan

27 March 2026 | CN | New Indication Alert: AZ/Daiichi Sankyo’s Enhertu® + THP Conditionally Approved in China for HER2-Positive Breast Cancer

On 27 March 2026, Daiichi Sankyo announced the conditional approval in China of Enhertu® (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab… Read more here.

Ustekinumab

9 April 2026 | AU | Biocon’s Ustekinumab Biosimilar Approved in Australia

On 9 April 2026, Biocon’s Yesintek®, biosimilar to Janssen’s Stelara® (ustekinumab), was approved in Australia in the following forms: 45 mg/0.5 mL solution for injection vial;… Read more here.

30 March 2026 | EU | Bio-Thera/Gedeon Richter’s Biosimilar Ustekinumab Launched in Europe

In a LinkedIn post on 30 March 2026, Gedeon Richter announced that it expects its ustekinumab biosimilar “to become progressively available across European markets starting… Read more here.

Vusolimogene oderparepvec

10 April 2026 | US | Replimune Announces Job Losses, Blames FDA Process, as RP1 Development Ends

On 10 April 2026, Replimune announced that the FDA had issued a complete response letter (CRL) to its BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab… Read more here.

Biopharma Deals

2 April 2026 | PH | Sandoz’s Philippines Business Acquired by Lotus Pharmaceutical

On 2 April 2026, Taiwan-headquartered Lotus Pharmaceutical announced that it has entered into an agreement to acquire Sandoz AG’s Philippines business. The acquisition is expected… Read more here.

About Pearce IP

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In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees). Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

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Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice. Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in Law “Executive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”. Ranked in Chambers Asia Pacific, Chambers Global, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks.

Pearce IP is the premier life sciences focussed firm in ANZ. Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees). In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

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.

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.

Maliha Hoque

Paralegal

Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®. She is currently completing her Juris Doctor at the University of Sydney. With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’. Maliha is interested in the intersection of law and science, and digital transformation. She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.

Sandoz’s Philippines Business Acquired by Lotus Pharmaceutical

Apr 14, 2026

On completion, Lotus will undertake the sales and marketing of Sandoz Philippines’ existing products, including biosimilars and generics covering therapeutic areas such as cardiovascular and oncology.

New Indication Alert: Regeneron/Sanofi’s Dupixent® (Dupilumab) EU-Approved for Young Children with CSU

Apr 13, 2026

On 13 April 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the European Commission for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years with inadequate response to histamine-1 antihistamines and who are naive to IgE therapy for CSU. The approval follows a positive CHMP opinion for the indication in February 2026.

The existing CSU indication in Europe (approved in November 2025) had covered adults and adolescents (12 years and above). According to Regeneron, an sBLA has been accepted for review in the US seeking approval for Dupixent® in children aged 2 to 11 years with CSU, with a decision expected by April 2026.

Biosimilar dupilumab is under development by at least Samsung Bioepis, Bio-Thera Solutions and Costa Rican-based SteinCares, Alvotech and Advanz and Binnopharm and Mabwell. In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection.

Replimune Announces Job Losses, Blames FDA Process, as RP1 Development Ends

Apr 10, 2026

On 10 April 2026, Replimune announced that the FDA had issued a complete response letter (CRL) to its BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. Sushil Patel, Ph.D., CEO of Replimune said, “As we previously communicated, without timely accelerated approval, the development of RP1 will not be viable. We are devastated for our committed employees who have worked tirelessly for patients but at this point we have no choice but to eliminate jobs, including substantially scaling back our U.S. based manufacturing operations.”

Replimune criticised several aspects of the CRL, claiming that the FDA “appears to have contradicted their positions expressed at the September 2025 Type A meeting.” Replimune noted that the FDA did not repeat its previous concerns about the heterogeneity of the patient population in the relevant clinical trial, and that it acknowledged that randomizing patients to an anti-PD1 only arm in the confirmatory study was not feasible.

Replimune submitted the BLA in November 2024 under the FDA’s Accelerated Approval pathway, with the FDA also granting Breakthrough Therapy Designation.

Apotex’s Generic Ozempic® (Semaglutide) Secures First FDA Tentative Approval

Apr 10, 2026

On 10 April 2026, Apotex announced that it received the first US FDA Tentative Approval for its Abbreviated New Drug Application (ANDA) for Semaglutide Injection, a generic version of Novo Nordisk’s Ozempic®. FDA Tentative Approval signifies that Apotex’s product meets all statutory and regulatory requirements for approval but cannot be marketed in the US because of patents or exclusivities related to the reference drug.

Apotex developed its Semaglutide Injection through a strategic partnership with Orbicular Pharmaceutical Technologies, headquartered in India.

The FDA Tentative Approval gives Apotex an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents. Numerous generic semaglutide products launched on the Indian market in March 2026, including by Dr Reddy’s Zydus, Alkem, Sun Pharma and Glenmark, following expiry of Novo Nordisk’s core Indian patent for semaglutide.

Apotex’s news follows Novo Nordisk’s announcement on 20 March 2026 that the FDA approved a new higher dose (7.2 mg) of Wegovy® (semaglutide) injection (Wegovy® HD) for weight loss and long-term maintenance of weight loss for certain adult patients. The approval was granted under the Commissioner’s National Priority Voucher (CNPV) pilot program. Wegovy® HD was subsequently launched in the US in April 2026.

Henlius Secures Clinical Trial Approval for Biosimilar Pertuzumab/Trastuzumab Combo in China, Doses First Patient

Apr 10, 2026

On 1 April 2026, Shanghai Henlius Biotech announced that its Investigational New Drug (IND) application for HLX319, biosimilar to Genentech/Roche’s Phesgo® (Perjeta® (pertuzumab), Herceptin® (trastuzumab) and hyaluronidase), has been approved by China’s National Medical Products Administration (NMPA). Shortly after, on 10 April 2026, the company reported that the first patient in its phase I clinical trial, HLX319-001, had been dosed.

HLX319 is intended for neoadjuvant/adjuvant treatment of HER2-positive early or locally advanced breast cancer, as well as for the treatment of metastatic breast cancer. The pertuzumab and trastuzumab used in HLX319 are Henlius’ self‑developed HLX11/Poherdy® and HLX02/Hanquyou®, together with a proprietary recombinant human hyaluronidase (rHuPH20).

In February 2026, HLX11/Poherdy® (pertuzumab) received a positive CHMP opinion in Europe for use (with trastuzumab and docetaxel) in adults with HER2-positive metastatic or locally recurrent unresectable breast cancer. It was also the first biosimilar to Genentech/Roche’s Perjeta® approved in the USA where a legal challenge was settled in January 2026.

HLX02/Hanquyou® (trastuzumab) has been approved in China since 2020, and under different names in Canada (August 2024), the US (April 2024), Australia (July 2022), and Europe (July 2020).

Biocon’s Ustekinumab Biosimilar Approved in Australia

Apr 9, 2026

On 9 April 2026, Biocon’s Yesintek®, biosimilar to Janssen’s Stelara® (ustekinumab), was approved in Australia in the following forms:

45 mg/0.5 mL solution for injection vial;
90 mg/1 mL solution for injection pre-filled syringe;
45 mg/0.5 mL solution for injection pre-filled syringe; and
130 mg/26 mL solution for intravenous infusion injection vial.

Yesintek® is manufactured by Biocon and is to be supplied in Australia by its local partner Generic Health. Maxx Pharma Pty Ltd is the sponsor listed on the Australian Register of Therapeutic Goods (ARTG).

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) is due to consider Yesintek® for listing on the Pharmaceutical Benefits Scheme (PBS) at its July 2026 meeting.

Yesintek® joins a growing number of ustekinumab biosimilars approved in Australia, including Amgen’s Wezlana® (January 2024) and Ajemnye® (May 2024), Celltrion’s Steqeyma® (first approved September 2024), Samsung Bioepis’ Epyztek® (October 2024) and Alvotech/Cipla’s Uteknix® (February 2025). To date, Celltrion’s Steqeyma® is the only ustekinumab biosimilar listed on the PBS (from 1 August 2025), with other ustekinumab biosimilars at varying stages of the PBAC approval process.

Yesintek® is approved in the US (December 2024), Japan (January 2025), Europe (February 2025), the UK (May 2025) and Canada (October 2025).

New Indication Alert: Shanghai Henlius’ Biosimilar Rituximab Approved in China for Two New Non-Hodgkin’s Lymphoma Indications

Apr 9, 2026

On 9 April 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has approved two new non-Hodgkin’s lymphoma indications for Hanlikang® (HLX01), biosimilar to Genentech/Biogen’s Rituxan®/MabThera® (rituximab).

The two new indications are:

in combination with polatuzumab vedotin, cyclophosphamide, doxorubicin, and prednisone for first line treatment of previously untreated adult patients with diffuse large B‑cell lymphoma (DLBCL); and
in combination with bendamustine and polatuzumab vedotin for the treatment of adult patients with relapsed or refractory DLBCL who are not candidates for hematopoietic stem cell transplant.

Rituximab was one of the first mAbs to become “biosimilar”, being first approved in the US on 26 November 1997. Henlius’ Hanlikang® was the first rituximab biosimilar approved in China in 2019, where its commercial sales are managed by Fosun Pharma. According to Henlius, Hanlikang® is approved for more indications in China than the reference product (being the only rituximab product approved in China to treat rheumatoid arthritis).

Other rituximab biosimilars approved in China include Innovent/Eli Lilly’s Halpryza® (approved October 2020) and Chia Tai Tianqing’s Delituo® (approved May 2023).

Apotex’s Denosumab Biosimilar Approved in Canada

Apr 7, 2026

On 7 April 2026, Apotex announced that Health Canada has approved Denoza™, biosimilar to Amgen’s Prolia® (denosumab), for all indications of the reference biologic.

Sandoz’s Wyost® (approved February 2024) and Jubbonti® (approved March 2024) were the first denosumab biosimilars approved in Canada, and were launched in August 2024. This was followed by the Canadian approvals of Celltrion’s Stoboclo® and Osenvelt® (September 2025) and Henlius/Organon’s Bildyos® and Tuzemty® (HLX14) (March 2026).

Biocon Launches Denosumab Biosimilars in US

Apr 7, 2026

On 7 April 2026, Biocon Limited announced that it has launched Bosaya™ and Aukelso™ (denosumab-kyqq), biosimilars to Amgen’s Prolia® and Xgeva®, respectively, in the US. The launch follows Biocon’s 1 October 2025 settlement and licence agreement with Amgen, which permitted Biocon’s US launch of the biosimilars from 1 October 2025.

Bosaya™ and Aukelso™ received FDA approval in September 2025 and were granted provisional interchangeability designation for all approved indications.

A number of denosumab biosimilars have been approved in the US. This includes Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, to be included on US formularies from 1 April 2026), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, launched October 2025), Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025; launched January 2026), Accord’s Osvyrti® and Jubereq® (approved November 2025) and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).

Outlook Therapeutics Submits Dispute Resolution Request to FDA For Ophthalmic Bevacizumab Following Regulatory Setbacks

Apr 7, 2026

On 7 April 2026, Outlook Therapeutics announced that it has submitted a formal dispute resolution request (FDRR) to the FDA following a Type A meeting in March 2026 in relation to its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.

The FDRR is an appeal process which permits a sponsor to obtain formal review of any FDA decision by raising the matter with the supervisor of the employee who made the decision. The FDA has accepted Outlook’s FDRR and has scheduled a meeting with the deciding official in April 2026.

The March 2026 Type A meeting was held to clarify an issue identified in a Complete Response Letter issued by the FDA in December 2025 regarding the second resubmission of Outlook’s Biologics Licence Application (BLA) for ONS-5010/Lytenava™. In the CRL, the FDA had recommended that additional confirmatory evidence be provided to support the application, though it did not clarify what type of evidence would be acceptable.

In its April 2026 press release, Outlook Therapeutics reiterated that it remains committed to its position “that data on safety and efficacy for Lytenava™ demonstrated in NORSE TWO and NORSE EIGHT provide sufficient evidence to support approval”.

Outlook Therapeutics received a first CRL from the FDA for Lytenava™ in August 2023 and subsequently submitted a Special Protocol Assessment request in December 2023 regarding further clinical trials. It resubmitted its BLA to the FDA in February 2025 based on positive results of the NORSE EIGHT clinical trial, announced in January 2025. A second CRL (issued in August 2025) recommended that Outlook submit additional efficacy data to support its application for Lytenava™. Outlook resubmitted its BLA to the FDA for a second time in early November 2025.

Lytenava™ was approved in the EU in May 2024 and was launched in the UK and Germany for wet AMD in June 2025. The Scottish Medicines Consortium accepted Lytenava™ for use within NHS Scotland in June 2025.

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

CuraTeQ Completes Ph 3 Biosimilar Omalizumab Trial

Apr 6, 2026

On 6 April 2026, Aurobindo’s wholly owned subsidiary, CuraTeQ Biologics, announced it has obtained positive top-line results from a Phase 3 study of BP11 (omalizumab, 300 mg), biosimilar to Genentech/Novartis’ Xolair®.

According to CuraTeQ, the study, which was conducted in 608 patients across 80 sites in Europe and India, successfully met all primary endpoints, demonstrating comparable efficacy and safety to Xolair® in patients with chronic spontaneous urticaria at the 300 mg dose.

Buoyed by these results, which follow completion of a Phase 1 study in March 2024, CuraTeQ is planning to complete regulatory filings with both the European Medicines Agency and the FDA by the end of Q2 2026.

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar on the market anywhere in the world. Omlyclo® has been approved in: the EU (May 2024, with a high dose (300 mg) form approved November 2025); Korea (June 2024, as PFS, with autoinjector approved December 2025; high dose formulation launched 30 March 2026); Australia (November 2024); Canada (December 2024, with a high dose formulation approved January 2026); the US (March 2025, in 75 mg/0.5ml and 150 mg/ml PFS forms, with full interchangeable status, and December 2025 in high dose); New Zealand (April 2025); and Japan (March 2026). Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025. In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil.

Biosimilar omalizumab is also under development. Teva announced in March 2026 that its regulatory applications for an omalizumab biosimilar have been accepted for review by the FDA and the European Medicines Agency for all approved reference indications. On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American Market. Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023). A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025 and by the European Medicines Agency in October 2025.

New Indication Alert: MSD’s Keytruda® Approved in EU for Ovarian Cancer

Apr 2, 2026

On 2 April 2026, MSD announced that the European Commission has approved Keytruda® (pembrolizumab) in combination with paclitaxel, with or without bevacizumab, for the treatment of platinum resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PDL1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens.

The EC approval follows a CHMP positive opinion in February 2026 for the indication, which was also approved by the FDA in February 2026 in both IV (Keytruda®) and subcutaneous (Keytruda Qlex™) formulations.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025). Pembrolizumab biosimilars are also under development including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, BioNTech, Alvotech and Formycon.

Bayer Reduces Eylea® Price in India by 44%

Apr 2, 2026

On 2 April 2026, The Economic Times reported that Bayer has reduced the upfront cost of Eylea® (aflibercept, 2mg) in India by about 44% to expand the eligible patient pool. According to the report, Eylea® will now be priced at Rs 29,998, down from Rs 53,141.

The announcement comes just under 2 months after Zydus’s Indian launch of its aflibercept biosimilar, Anyra™. Anyra™ is the first aflibercept 2mg biosimilar developed in India and was launched under licence from Regeneron and Bayer.

There is at least one other aflibercept biosimilar set to launch in India in 2026. In September 2025, Biocon’s Yesafili® was recommended by India’s Subject Expert Committee (SEC). This recommendation was subject to Biocon submitting a Phase IV clinical trial protocol to the Central Drugs Standard Control Organisation within 3 months of obtaining the marketing authorisation grant. In January 2026, Biocon reached a settlement and licence agreement with Regeneron and Bayer for Yesafili® in Europe and ROW, which permits Biocon to commercialise Yesafili® in India (and ROW other than UK, US and Canada) in H2 2026.

Eylea® was jointly developed by Bayer and Regeneron. Regeneron holds the exclusive rights to Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

FDA Approves Extended Dosing Interval for Regeneron/Bayer’s Eylea HD®

Apr 2, 2026

On 2 April 2026, Regeneron announced that the FDA has approved an extended dosing interval for Eylea HD® (aflibercept 8mg, “high dose”) of up to every 20 weeks for patients with nAMD and diabetic macular oedema (DME), following one year of successful response based on visual and anatomic outcomes. The new dosing regimen means that nAMD/DME patients can be treated as little as 2-3 times a year.

The approval of the extended dosing regimen is based on 96 week data from the PHOTON and PULSAR trials. It follows FDA approval of Eylea® HD in November 2025 for RVO with up to 8 weekly dosing after an initial monthly dosing period, and a 4-weekly dosing option for patients who may benefit from resuming this dosing schedule across approved indications (nAMD, DME, DR and RVO).

Regeneron’s pre-filled syringe (PFS) supplementary BLA for Eylea HD® has an FDA target action date in April 2026. The BLA had been on hold while Regeneron sought to resolve inspection findings at Catalent reported in an October 2025 Complete Response Letter from the FDA. Catalent (part of Novo Nordisk) is the manufacturer filler included in Regeneron’s sBLA. Regeneron had planned to submit to the FDA an application to include an alternate PFS manufacturing filler for its Eylea HD® BLA by January 2026.

Eylea HD® (known as Eylea™ 8mg in other jurisdictions), 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.

High dose Eylea® is approved for RVO in the US (November 2025), Europe (January 2026), the UK (February 2026) and Korea (February 2026). It is also approved for nAMD and DME (as intravitreal injection) in those and multiple other countries, including Australia (June 2024). Eylea™ 8mg pre-filled syringe (OcuClick™) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025).

Alvotech is developing AVT29, a biosimilar to Regeneron/Bayer’s Eylea™ 8mg. In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 in Europe. Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US. Alvotech has recently indicated that it expects to file the first regulatory submission for AVT29 sometime in 2026.

Biosimilars of Regeneron/Bayer’s Eylea® (aflibercept, 2mg) are already on the market around the world, including, for example, Alvotech’s Mynzepli® (launched in the UK, Canada and Japan), Amgen’s Pavblu® (available in the US), Sandoz’s Afqlir®/Enzeevu® (launched in the UK, Australia and Canada), Samsung Bioepis’ Afilivu® (available in Korea) and Celltrion’s Eydenzelt® (launched in the UK and Europe).

Pearce IP BioBlast® for the week ending 27 March 2026

Mar 31, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 27 March 2026 are set out below:

Aflibercept

23 March 2026 | JP | New Indication Alert: Regeneron/Bayer’s Eylea™ 8 mg Approved in Japan for RVO

On 23 March 2026, Bayer announced that Japan’s Ministry of Health, Labour and Welfare has approved Eylea™ 8 mg (aflibercept 8mg) for the treatment of macular oedema following… Read more here.

Bevacizumab

24 March 2026 | US | EU | Prestige Biopharma & Intas/Accord Healthcare Prepare for Biosimilar Bevacizumab Commercialisation in US/EU

On 24 March 2026, Singapore-headquartered Prestige Biopharma announced that it is “accelerating commercialisation” of Vasforda®/HD204, biosimilar to Genentech’s Avastin®… Read more here.

Denosumab

24 March 2026 | CA | Henlius/Organon’s Denosumab Biosimilars Approved in Canada

On 24 March 2026, Shanghai Henlius Biotech announced that Health Canada has approved Bildyos® and Tuzemty® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva®… Read more here.

Daratumumab

27 March 2026 | EU | J&J’s Darzalex® (Daratumumab) First EU Approved Oncology Injectable for Self-Administration

On 27 March 2026, Johnson & Johnson announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved a label update… Read more here.

Dupilumab

24 March 2026 | JP | New Indication Alert: Dupixent® (Dupilumab) First Targeted Medicine for Adults with Bullous Pemphigoid (BP)

On 24 March 2026, Regeneron and Sanofi announced that the Japanese Ministry of Health, Labour and Welfare has approved Dupixent^® (dupilumab) for the treatment of adults with… Read more here.

Golimumab

23 March 2026 | IN | Bio-Thera & Intas Partner to Supply Biosimilar Golimumab in India

On 23 March 2026, Bio-Thera Solutions announced that it has entered an exclusive agreement with Intas Pharmaceuticals for the Indian commercialisation of BAT2506 (golimumab)… Read more here.

Insulin icodec

27 March 2026 | US | Novo Nordisk’s Once Weekly Insulin, Awiqli®, Approved in US

On 27 March 2026, Novo Nordisk announced that the FDA has approved Awiqli® (insulin icodec-abae) injection 700 units/mL as the first and only once-weekly, long acting basal… Read more here.

Omalizumab, Aflibercept

27 March 2026 | JP | Celltrion’s Omalizumab & Aflibercept Biosimilars Approved in Japan

On 27 March 2026, Celltrion announced that Japan’s Ministry of Health, Labour and Welfare has approved two of its biosimilars: Omlyclo®, biosimilar to Genentech/Novartis’… Read more here.

Tocilizumab

23 March 2026 | JP | Gedeon Richter/Mochida’s Biosimilar Tocilizumab Approved in Japan

On 23 March 2026, Mochida Pharmaceutical and Ayumi Pharmaceutical announced that RGB-19, biosimilar to Roche’s RoActemra® (tocilizumab) was approved in Japan… Read more here.

Ustekinumab, Aflibercept

25 March 2026 | AU | Ustekinumab & Aflibercept Biosimilars on the July 2026 PBAC Agenda

On 25 March 2026, the Australian Pharmaceutical Benefits Assessment Committee (PBAC) published the agenda for its July 2026 meeting, with three biosimilars submitted… Read more here.

Biopharma Deals

23 March 2026 | JP | Yoshindo Strengthens Plans to Establish Biosimilar Manufacturing Capabilities in Japan with Cytiva Contract

On 23 March 2026, Cytiva announced that it has entered a contract with Yoshindo to support Yoshindo’s plans to establish biosimilar manufacturing capabilities for the Japanese… Read more here.

Biopharma News

27 March 2026 | EU | CHMP Adopts EMA’s Reflection Paper on Streamlining Biosimilar Development

At its March 2026 meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted the EMA’s April 2025 “Reflection paper… Read more here.

About Pearce IP

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CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

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Special Counsel, Lawyer

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Xbrane Delays US Ranibizumab Biosimilar BLA Resubmission to April/May 2026

Mar 31, 2026

On 31 March 2026, Xbrane provided an update on the resubmission of its ranibizumab biosimilar BLA to the FDA following a Complete Response Letter (CRL) received in October 2025. In November 2025, Xbrane had indicated that it expected to resubmit its BLA in March 2026. However, following Xbrane’s contract manufacturer receiving “further detailed feedback from the FDA”, Xbrane’s resubmission plans have now been delayed to April/May 2026.

According to Xbrane, following resubmission of the BLA for its biosimilar to Genentech’s Lucentis®, an FDA 6-month review process is likely, resulting in an expected Biosimilar User Fee Amendment (BsUFA) date in October/November 2026.

The ranibizumab biosimilar is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is the subject of an exclusive licensing agreement with US biosimilars specialist Valorum Biologics, which will be responsible for commercialisation in the US.

There are currently three ranibizumab biosimilars approved in the US. The first approved was Samsung Bioepis’ Byooviz® (September 2021), followed by Formycon/Sandoz’s Cimerli® (August 2022) and Formycon’s Nufymco® (December 2025).

Xbrane’s ranibizumab biosimilar has been approved in the EU and UK since November 2022, under the name Ximluci®. It was launched in the EU in April 2023.

Henlius/Organon Settle US Denosumab Litigation with Amgen

Mar 31, 2026

Shanghai Henlius and Organon have settled US BPCIA litigation brought by Amgen in June 2025 in relation to their denosumab biosimilars, Bilprevda® and Bildyos® (HLX14), as recorded by a Consent Order and Judgment filed with the US District Court for the District of New Jersey on 31 March 2026. Henlius/Organon consented to an order that 26 US patents asserted by Amgen (relating to Amgen’s Prolia®/Xgeva® (denosumab)) are valid and infringed by making, using, selling or offering to sell Henlius/Organon’s denosumab biosimilars in the US, or importing them into the US.

There has been no announcement by the parties in relation to the settlement and whether a US launch date for Bilprevda® and Bildyos® has been agreed. Samsung Bioepis’ Q1 2026 Biosimilar Market Report had indicated the products had launched in the US in October 2025.

Bildyos® and Bilprevda® were approved in the US in September 2025. Shanghai Henlius entered into a licence agreement with Organon in June 2022 under which Organon has exclusive global commercialisation rights to HLX14 (denosumab) for all countries except China, Hong Kong, Macau and Taiwan.

The BPCIA litigation against Henlius/Organon was one of a number of US proceedings brought by Amgen in relation to biosimilar denosumab, many of which have now settled. Amgen has entered into US denosumab litigation settlements with Sandoz (settlement in April 2024, Jubbonti® and Wyost® launched June 2025); Fresenius Kabi (March 2025 settlement, Conexxence® and Bomyntra® launched early July 2025); Celltrion (settlement in January 2025, Stoboclo® and Osenvelt® launched July 2025, following January 2025 settlement); Accord/Intas (settlement in July 2025, FDA approval of Osvyrti® and Jubereq® in November 2025); Biocon (Bosaya™ and Aukelso™ launched 1 October 2025 following settlement shortly after commencement of proceedings in June 2025); Samsung Bioepis (settlement in September 2025, Ospomyv® included on US formularies from 1 April 2026); and Gedeon Richter/Hikma (settlement in November 2025, Enoby™ and Xtrenbo™ launched in January 2026).

Amgen still has pending US denosumab litigation against Alvotech/Dr Reddy’s and Amneal/mAbxience (commenced 6 November 2025) and Alkem (commenced 14 November 2025).

Bio-Thera/Gedeon Richter’s Biosimilar Ustekinumab Launched in Europe

Mar 30, 2026

In a LinkedIn post on 30 March 2026, Gedeon Richter announced that it expects its ustekinumab biosimilar “to become progressively available across European markets starting from March 2026”.

Gedeon Richter is commercialising the ustekinumab biosimilar in Europe under a licence and commercialisation agreement entered into with Bio-Thera in October 2024. Under the agreement, Bio-Thera is responsible for the development and manufacture of BAT2206 (ustekinumab), while Richter has commercialisation rights for the EU, UK and Switzerland.

BAT2206 was approved in the EU in August 2025 (as Usymro®), following a positive CHMP opinion in June 2025.

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

Celltrion Launches High Dose (300 mg) Biosimilar Omalizumab in Korea

Mar 30, 2026

On 30 March 2026, Celltrion announced that it launched its high dose (300 mg) Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, in Korea, as reported by Korea Biomedical Review.

The Korean launch follows the January 2026 Canadian approval of high dose Omlyclo® (PFS and autoinjector) and approvals of a PFS presentation of the 300 mg dosage form in the US in December 2025 and EU in November 2025.

Celltrion is actively marketing Omlyclo® around the world, with a “launch event” held in Brazil on 31 March 2026, at which Celltrion and “key opinion leaders” presented clinical data, global prescribing experience and “value for use in clinical settings” in relation to the biosimilar. Omlyclo® was launched in Brazil in November 2025 and secured a state government tender in Santa Catarina.

While Omlyclo® is currently the only omalizumab biosimilar on the market anywhere in the world, at least Aurobindo, Teva, Glenmark and Kashiv have omalizumab biosimilars under development. On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American Market. Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023). A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025 and by the European Medicines Agency in October 2025.

Teva’s Biosimilar Denosumab FDA-Approved & Biosimilar Omalizumab Applications Accepted for Review in US & EU

Mar 30, 2026

On 30 March 2026, Teva Pharmaceutical Industries announced that the FDA has approved Ponlimsi™, biosimilar to Amgen’s Prolia® (denosumab). At the same time, Teva also announced that its regulatory applications for a biosimilar to Genentech/Novartis’ Xolair® (omalizumab) have been accepted for review by the FDA and the European Medicines Agency for all approved reference indications.

Ponlimsi® was approved in the EU in November 2025, together with Teva’s biosimilar to Amgen’s Xgeva® (denosumab), Degevma®. The US has a highly competitive denosumab biosimilar market with a number of denosumab biosimilars already launched, including Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, launched October 2025), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), and Gedeon Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025, launched January 2026).

Teva’s omalizumab biosimilars are behind Celltrion’s Omlyclo® (omalizumab), which has already been approved in the EU (May 2024; high dose (300mg) form approved November 2025) and the US (March 2025, in 75 mg/0.5ml and 150mg/ml PFS forms, with full interchangeable status, and December 2025 in high dose). Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025. Aurobindo, Glenmark and Kashiv reportedly also have omalizumab biosimilars under development.

CHMP Adopts EMA’s Reflection Paper on Streamlining Biosimilar Development

Mar 27, 2026

At its March 2026 meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted the EMA’s April 2025 “Reflection paper on a tailored clinical approach in biosimilar development”. Stakeholders had been invited to provide comments on the draft reflection paper by 30 September 2025. The version of the paper adopted by the CHMP can be accessed here.

As reported in April 2025, the reflection paper considers that waiving certain clinical data requirements would simplify the development and evaluation process of biosimilars while maintaining the highest standards of safety and efficacy.

According to the EMA, advances in analytical characterisation, and its extensive regulatory experience in approving significant changes in manufacturing processes of biological medicines by confirmation of structural and functional comparability, “supports the notion that under specific prerequisites, analytical comparability exercises and pharmacokinetic (PK) data can be sufficient for demonstrating biosimilarity”.

The reflection paper concludes that a tailored approach for clinical development of biosimilar candidates is possible, with Comparative Efficacy Studies no longer expected to be required for approval of biosimilars that can be “thoroughly characterised using state-of-the-art analytical methods and [which] have demonstrated similarity in physicochemical and functional properties”. The paper expects this tailored clinical approach to be “applicable for the majority of biosimilar candidates”.

Celltrion’s Omalizumab & Aflibercept Biosimilars Approved in Japan

Mar 27, 2026

On 27 March 2026, Celltrion announced that Japan’s Ministry of Health, Labour and Welfare has approved two of its biosimilars: Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), and Eydenzelt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), 2mg.

According to Celltrion, Omlyclo® is the first omalizumab biosimilar approved in Japan with the full range of on‑label indications, namely bronchial asthma, idiopathic chronic urticaria, and seasonal allergic rhinitis. The product will be offered in both prefilled syringe (PFS) and autoinjector (AI) presentation.

Omlyclo® was the first omalizumab biosimilar approved in: the EU (May 2024); Korea (June 2024, as PFS, with autoinjector approved December 2025); Australia (November 2024); Canada (December 2024, with a high dose formulation approved January 2026); the US (March 2025, in 75 mg/0.5ml and 150mg/ml PFS forms, with full interchangeable status); and New Zealand (April 2025). Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025. In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil, Latin America’s largest pharmaceutical market. Aurobindo, Teva, Glenmark and Kashiv reportedly also have omalizumab biosimilars under development

A number of aflibercept biosimilars are approved in Japan including Alvotech/Fuji Pharma’s AVT06 (September 2025) and Sam Chun Dang’s SCD411 (September 2025). Under a settlement and licence agreement with Regeneron & Bayer announced in January 2026, Alvotech was permitted to launch AVT06 in Japan from 1 January 2026.

Novo Nordisk’s Once Weekly Insulin, Awiqli®, Approved in US

Mar 27, 2026

On 27 March 2026, Novo Nordisk announced that the FDA has approved Awiqli® (insulin icodec-abae) injection 700 units/mL as the first and only once-weekly, long acting basal insulin for adults with type 2 diabetes.

The US approval follows the issue of a Complete Response Letter (CRL) by the FDA on 10 July 2024 regarding insulin icodec. At the time, the CRL was said to include “requests related to the manufacturing process and the type 1 diabetes indication”.

Awiqli® was recommended for EU approval on 22 March 2024 and subsequently received EU marketing authorisation for treating diabetes in May 2024. It has been approved in Switzerland and Canada (March 2024), Japan and Australia (June 2024) and was endorsed in China in June 2024 for type 2 diabetes.

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