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).

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.

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).

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.

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 to be completed in Q2 2026, subject to closing conditions.

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.

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.

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.

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).

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.

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.