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, 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 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.

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).

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).

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:

1. 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
2. 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).

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).

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).

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.