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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.

JAMP Pharma Secures First Biosimilar Golimumab Approval in Canada

Apr 20, 2026

On 20 April 2026, PR Newswire reported that Health Canada has approved JAMP Pharma’s Upgolyv™, biosimilar to Janssen’s Simponi® (golimumab), for the treatment of chronic inflammatory autoimmune diseases. Upgolyv™ is the first golimumab biosimilar to be approved in Canada.

Clinical studies relied on by JAMP Pharma in its application for approval of Upgolyv™, AVT05-GL-P01 (NCT05632211) and AVT05-GL-C01 (NCT05842213), were sponsored by Alvotech, and were conducted with the Alvotech-developed golimumab biosimilar, AVT05. It is therefore apparent that Upgolyv™ is being commercialised by JAMP Pharma in Canada via an association with Alvotech. In March 2026, Alvotech confirmed during its Q4/2025 Earnings call that an application for approval of AVT05 had been filed in Canada, with a decision expected in H1 2026, although no commercialisation partner was mentioned at that time.

Alvotech and JAMP Pharma have previously partnered on the Canadian launch of Jamteki® (biosimilar ustekinumab) and announced their exclusive partnership for the commercialisation of five biosimilars in Canada in January 2020, expanded to seven biosimilars in October 2022.

Alvotech’s Gobivaz® (AVT05) was the first golimumab biosimilar approved worldwide in September 2025 in Japan. The launch of Gobivaz® in Japan (commercialised by Fuji Pharma) is planned for May 2026. Gobivaz® received a positive CHMP opinion from the EMA in September 2025, followed by approval in Europe and the UK in November 2025, where it is commercialised by Advanz Pharma. In the US, where AVT05 will be commercialised by Teva, the FDA issued a Complete Response Letter (CRL) for the biosimilar in November 2025.

Bio-Thera’s Gotenfia®/BAT2506 (golimumab ), marketed by STADA in the EU and UK, received a positive CHMP opinion in December 2025 and EU approval in February 2026. Bio-Thera’s BLA for BAT2506 was accepted for review by the FDA in July 2025. However, there is ongoing US litigation relating to BAT2506, with Janssen having filed proceedings against Bio-Thera Solutions/Accord BioPharma, alleging infringement of 17 patents. A preliminary injunction application by Janssen is due to be heard in August or the beginning of September 2026.

FDA Grants Priority Review of Pfizer/Astella’s sBLA for Enfortumab Vedotin Plus Pembrolizumab for MIBC Regardless of Cisplatin Eligibility

Apr 20, 2026

On 20 April 2026, Astellas Pharma and Pfizer announced that the FDA granted priority review of the sBLA for Astella Pharma/Pfizer’s Padcev™ (enfortumab vedotin-ejfv) in combination with MSD’s Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph), for the treatment of muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility.

The combination received FDA approval in November 2025 for cisplatin-ineligible patients with MIBC. The sBLA seeks to expand the indication to patients regardless of cisplatin eligibility

The FDA has set a target action date under the Prescription Drug User Fee Act of 17 August 2026.

Samsung Bioepis Showcases Strong Patient Subgroup Consistency for Biosimilar Denosumab

Apr 17, 2026

On 17 April 2026, Samsung Bioepis announced new clinical data reinforcing the efficacy of its denosumab biosimilar, SB16 (Obodence®, referred to in the US as Ospomyv®), and highlighting consistent outcomes across diverse patient subgroups. The findings were presented at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) held in Prague from 16-19 April 2026.

The data results from a Phase 3 clinical trial of SB16 involving 456 postmenopausal women with osteoporosis. The subgroup analysis assessed the consistency of treatment effects across key patient characteristics, including age, body mass index, prior oral bisphosphonate use, smoking status, and presence of vertebral fractures.

SB16 demonstrated comparable efficacy to the reference product (Amgen’s Prolia® (denosumab)) across all evaluated subgroups. According to Samsung Bioepis, the results further strengthen the “totality of evidence” supporting SB16’s biosimilarity.

Samsung Bioepis’ Ospomyv® was the second Prolia® biosimilar approved in the US (in February 2025) and was scheduled to be offered on US formularies from 1 April 2026. BPCIA litigation commenced by Amgen alleging that Samsung Bioepis’ denosumab biosimilars infringed 36 US patents relating to denosumab was settled in September 2025. Samsung Bioepis’ denosumab biosimilars have also been approved elsewhere, including Europe (February 2025, Obodence® launched from December 2025), Korea (Obodence® launched July 2025), and Australia (July 2025, not yet launched).

Teva’s US$176.5M Damages Award Reinstated in US Patent Proceedings Against Eli Lilly Regarding CGRP Antibody Headache Drug

Apr 16, 2026

On 16 April 2026, the US Court of Appeals for the Federal Circuit published its decision in an appeal by Teva Pharmaceuticals in proceedings commenced in September 2018 alleging that Eli Lilly indirectly infringed Teva’s US patents 8586045, 9884907 and 9884908. The patents relate to methods of treating headache using humanised anti-CGRP antagonist antibodies, such as Teva’s Ajovy® (fremanezumab-vfrm).

In the proceedings before the US District Court for the District of Massachusetts, the jury found that Eli Lilly wilfully infringed the asserted claims of the patents via its Emgality® (galcanezumab-gnlm) and awarded Teva US$176.5 million in damages. The jury also found the asserted claims of the patents to be valid. The District Court subsequently overturned the jury’s verdict on validity, granting “judgment as a matter of law” (JMOL) that the asserted claims are invalid for lack of written description and enablement. Teva appealed to the Court of Appeals.

In relation to written description, which requires that the inventor of a patent “had possession of the claimed subject matter” of that patent at its filing date, the relevant dispute concerned whether the specification disclosed a representative number of species of the asserted claims’ genus of anti-CGRP antagonist antibodies. The Court of Appeals determined that the patents make clear that the claimed invention is the use of anti-CGRP antagonist antibodies to treat headache, not the antibodies themselves, and a reasonable jury could have found facts sufficient to show that the inventors had possession of the invention, including that methods of making the antibodies, and humanisation of antibodies, were well-known in the prior art.

In relation to enablement, which requires that the patent specification “must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation”, Eli Lilly argued that there was insufficient teaching in the specification for the large number of candidate antibodies included in the claimed genus. However, the Court concluded that because the asserted claims were to a method of treatment (not to the antibodies themselves), and the specification disclosed that all the claimed antibodies worked for the claimed method of treatment, the District Court’s finding of no enablement was improper.

Helen Macpherson Earns Dual Rankings in 2027 Best Lawyers In Australia™

Apr 16, 2026

We are pleased to announce that Helen Macpherson, Pearce IP’s Executive Lawyer and Head of Litigation (Australia), has been recognised in 2027 The Best Lawyers in Australia™ for Intellectual Property Law and Life Sciences. Helen has been listed by Best Lawyers every year since 2017.

This recognition is determined entirely through peer review and reflects the high regard in which Helen is held across the legal profession. Her expertise, integrity, and commitment continue to exemplify excellence in the delivery of legal and IP services in Australia.

Founder and CEO Naomi Pearce says:

“Helen’s determination and outstanding legal capability make her invaluable to our clients and her team. This recognition, well deserved, reflects her consistent pursuit of excellence and her long-held position as one of Australia’s best IP lawyers. Congratulations, Helen.”

Helen says:

“It is a privilege to be recognised once again by my peers through Best Lawyers. I am proud to be part of the Pearce IP team, where there is a shared commitment to achieving outstanding outcomes in IP and life sciences law. This recognition reflects not only individual effort, but also the strength and collaboration of our team.”

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

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.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

Mabwell Secures Expanded Indication in China & Licensing Deal in Malaysia for Denosumab Biosimilars

Apr 15, 2026

On 15 April 2026, Mabwell announced that China’s National Medical Products Administration (NMPA) has approved the supplemental Biologics Licence Application for Maiweijian™, biosimilar to Amgen’s Xgeva® (denosumab). The approval expands the product’s indication to include the treatment of patients with multiple myeloma to prevent skeletal-related events and patients with bone metastases from solid tumours.

Maiweijian™ was initially approved by the NMPA in April 2024 for the treatment of giant cell tumour of the bone that is unresectable or where surgical resection may lead to severe functional impairment. It was developed by Mabwell’s wholly owned subsidiary, T-mab. Mabwell’s Mailishu®, biosimilar to Amgen’s Prolia® (denosumab), was approved by the NMPA in March 2023.

A day after the approval in China, on 16 April 2026, Mabwell announced that it entered into a licensing and commercialisation agreement with an unidentified strategic business partner for Maiweijian™ and Mailishu® in Malaysia. Under the terms of the agreement, the partner will be responsible for the registration and commercialisation of the denosumab biosimilars in Malaysia, whilst Mabwell will be responsible for the development, manufacturing and supply of the biosimilars.

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

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

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.

US Appeals Court Confirms No Preliminary Injunction Preventing Samsung Bioepis from Private Label Ustekinumab Supply

Apr 14, 2026

On 14 April 2026, the US Court of Appeals for the Third Circuit published its judgment confirming the District Court’s decision to refuse to grant a preliminary injunction to prevent Samsung Bioepis from supplying its biosimilar ustekinumab to Cigna’s Quallent.

The decision arises from a complaint filed by Johnson & Johnson/Janssen in the US District Court for the District of New Jersey on 24 February 2025 alleging that Samsung Bioepis had breached a settlement and licence agreement entered in July 2023 (announced in November 2023). The agreement permitted Samsung Bioepis to launch Pyzchiva®/SB17 (ustekinumab), biosimilar to J&J/Janssen’s Stelara®, in the US from 22 February 2025. In November 2024, Samsung Bioepis entered into a Private Label Distributor (PLD) Agreement with Quallent Pharmaceuticals Health LLC, a subsidiary of the Cigna Group. J&J/Janssen alleged that the sublicence to Quallent breached the settlement agreement and Janssen filed a motion for a preliminary injunction to prevent Samsung from supplying Quallent or authorising Quallent to distribute SB17 while the litigation was pending.

The US District Court refused to grant a preliminary injunction on the basis that Janssen had failed to establish that it would suffer irreparable harm if the injunction was not granted. The Appeals Court found no error in that decision. J&J/Janssen’s underlying breach of contract case remains ongoing.

Pyzchiva® was launched in the US by Sandoz in February 2025 (in PFS and vial forms), under a September 2023 development and commercialisation agreement with Samsung Bioepis. That agreement gives Sandoz the right to commercialise Pyzchiva® in the US, as well as Europe, Switzerland, the UK and Brazil. Pyzchiva® was launched in Europe in July 2024 and a Pyzchiva® autoinjector was launched in May 2025 as the first commercially available biosimilar ustekinumab pre-filled pen in Europe.

J&J has previously entered into ustekinumab settlement agreements with Amgen (which launched its biosimilar, Wezlana®, in the US in early January 2025 through Optum Health Solution’s private label subsidiary Nuvaila), Alvotech and Teva (Selarsdi® launched on 21 February 2025), Biocon (Yesintek™ launched on 24 February 2025), Celltrion (Steqeyma® launched March 2025), and Fresenius Kabi and Formycon (Otulfi® launched March 2025). Other ustekinumab biosimilars launched in the US include Dong A-ST/Accord’s Imuldosa® (launched August 2025) and Bio-Thera/Hikma’s Starjemza™ (launched November 2025).

Henlius’ Cetuximab Biosimilar IND Application Approved in China

Apr 14, 2026

On 14 April 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has approved an Investigational New Drug (IND) application for HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab), for the treatment of metastatic colorectal cancer (mCRC).

According to Henlius, it now plans to commence an international multicentre Phase 1 clinical study of HLX05-N “once the necessary conditions are met”.

Other cetuximab biosimilars have been approved globally, primarily for the treatment of mCRC and head and neck squamous cell carcinoma (HNSCC). Alkem’s Cetuxa™ was reportedly the first cetuximab biosimilar to be approved and launched, having been approved in India in January 2023 and launched in May 2023. Alkem’s biological arm, Enzene, entered into a strategic collaboration with Lupin in May 2023 for Indian commercialisation of Cetuxa™. Simcere Zaiming/Mabpharm’s Enlituo® (cetuximab beta) was approved in China in June 2024. In February 2026, R-Pharm’s Arcetux™ (cetuximab) was the first biosimilar cetuximab to gain approval in Russia.

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.

Daiichi Sankyo/MSD’s Ifinatamab Deruxtecan Granted FDA Priority Review

Apr 13, 2026

On 13 April 2026, Daiichi Sankyo announced that the FDA has accepted for priority review a Biologics License Application (BLA) for Daiichi Sankyo/MSD’s ifinatamab deruxtecan (I-DXd) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Ifinatamab deruxtecan was granted Breakthrough Therapy Designation by the FDA for the same indications in August 2025.

The FDA review of the BLA is being 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. It is also being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which facilitates earlier submission of topline efficacy and safety results, prior to the submission of the complete application, to support an earlier start to the FDA’s evaluation of the application.

In October 2023, Daiichi Sankyo and MSD entered into a global development and commercialisation collaboration for three of Daiichi’s deruxtecan antibody-drug conjugates (ADCs), including ifinatamab deruxtecan. Under that agreement, Daiichi and MSD agreed to jointly develop and commercialise the ADCs around the world, excluding Japan where Daiichi retains exclusive commercialisation rights. Daiichi is solely responsible for manufacture and supply of the products.

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.

BioNTech and DualityBio Report Phase 2 Success as Trastuzumab Pamirtecan BLA Advances in China

Apr 11, 2026

On 11 April 2026, BioNTech reported positive results for BioNTech and DualityBio’s investigational antibody drug conjugate, BNT323/DB-1303 (trastuzumab pamirtecan) in a Phase 2 cohort of patients with HER2-expressing, advanced endometrial cancer. The results are part of a global Phase 1/2a study assessing the safety and tolerability of trastuzumab pamirtecan in multiple solid tumours.

The Phase 2 cohort included 145 patients and, according to BioNTech, met its primary efficacy endpoint, with data demonstrating clinically meaningful antitumor activity across all HER2 expression levels and a manageable safety profile.

BioNTech and DualityBio intend to file a Biologics License Application (BLA) in the US in 2026, “subject to regulatory feedback from the FDA”.

A BLA has already been filed for BNT323/DB-1303 in China, with DualityBio announcing on 9 April 2026 that the BLA had been accepted for review by China’s National Medical Products Administration (NMPA) in respect of the treatment of unresectable or metastatic HER2-postiive adult breast cancer.

Trastuzumab pamirtecan is being developed by BioNTech and DualityBio and was “built from” DualityBio’s Duality Immune Toxin Antibody Conjugates (“DITAC”) platform. In addition to the Phase 1/2 trial in patients with advanced/metastatic solid tumours, the ADC is being evaluated in two global Phase 3 trials: Fern-EC-01 (HER2 expressing advanced recurrent endometrial cancer) and DYNASTY-Breast02 (metastatic breast cancer).

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.

Biocon Joins Alvotech in Filing US PGR Challenging Regeneron’s High Dose Aflibercept Patent

Apr 2, 2026

On 2 April 2026, Biocon filed a petition for post grant review (PGR) of Regeneron’s patent US12168036 entitled “Methods for Treating Angiogenic Eye Disorders with High Doses of VEGF Receptor Fusion Proteins”.

Biocon’s petition seeks to join Alvotech’s pending PGR in relation to the same patent. Alvotech’s PGR petition was filed on 17 September 2025 and the PGR was instituted by the Patent Trial and Appeal Board on 3 March 2026. Biocon’s PGR petition is substantially the same as that filed by Alvotech.

Regeneron’s ‘036 patent relates to methods for treating an angiogenic eye disorder by intravitreal administration of about 100 microlitres or less of at least about 8mg of a VEGF receptor fusion protein in a formulation with a particular viscosity. Both Biocon’s and Alvotech’s PGR petitions argue that the claims of the ‘036 patent are invalid for obviousness and lack of written description.

High dose Eylea® is approved in the US (as Eylea HD®) for wet age-related macular degeneration, diabetic macular oedema, diabetic retinopathy (August 2023) and retinal vein occlusion (November 2025). It is also approved in other jurisdictions (as Eylea™ 8mg), including Europe (January 2026), the UK (February 2026) and Korea (February 2026). 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 HD®. 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.

Biocon has not yet announced that it has a high dose Eylea® biosimilar in development. Biocon’s Yesafili™ was one of the first approved interchangeable aflibercept (2 mg) biosimilars in the US in May 2024. Biocon and Regeneron settled US BPCIA litigation regarding aflibercept (2 mg) in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026, or earlier under certain undisclosed circumstances.

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.

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