At the March 2026 PBAC Meeting (outcomes published on 24 April 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended reimbursement of the following biosimilars:

• Amgen’s Amgevita® (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syringe (PFS), and 40mg/0.4ml and 80mg/0.8ml pre-filled pen (PFP);
• Celltrion’s Yuflyma® (adalimumab) in 20mg/0.2ml PFS;
• Celltrion’s Omlyclo® (omalizumab) in 75mg/0.5ml and 150mg/1ml PFP;
• Sandoz’s Ardelya® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS;
• Amgen’s Wezlana® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS and 130 mg in 26 mL solution for IV infusion.

Amgen’s high concentration adalimumab biosimilar, Amgevita®, was TGA-approved in September 2025, while Celltrion’s high concentration adalimumab Yuflyma® was TGA-approved in September 2024, June 2023 and March 2022 as 20mg/0.2ml PFS, 80mg/0.8ml and 40mg/0.4ml, respectively.  Yuflyma® was first PBS-listed in March 2023 (40mg/0.4ml).  There are a number of other high concentration biosimilars to AbbVie’s Humira® approved in Australia, including Samsung Bioepis’ Hadlima® (approved February 2023, PBS-listed by Organon October 2024) and Sandoz’s Hyrimoz® (approved May 2024 and PBS-listed January 2025).

Celltrion’s Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, was previously PBS-listed on 1 August 2025 (in 75 mg/0.5ml and 150 mg/1ml PFS) and was launched in Australia in September 2025.  The March 2026 PBAC recommendation relates to the pre-filled pen presentation, which was TGA approved in August 2025.

Amgen’s Wezlana® (ustekinumab), biosimilar to Janssen’s Stelara®, was first recommended for PBS listing at PBAC’s April 2024 meeting.  However, Amgen did not proceed with the listing at that time and requested PBS listing of Wezlana® be put back on the agenda at the March 2026 PBAC meeting.  PBAC has extended its March 2024 recommendation for a further 12 months, supporting the PBS listing of Wezlana®.

Sandoz’s Ardelya® (ustekinumab) has also been recommended for PBS listing but is yet to receive marketing approval in Australia.

Celltrion’s Steqeyma® was the first ustekinumab biosimilar to be PBS-listed on 1 August 2025.  Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS listing at PBAC’s March 2025 meeting, but has not yet progressed to PBS listing, pending lodgement of required documentation.

On 27 April 2026, Samsung Bioepis published its 13th US Biosimilar Market Report, which has been released every quarter since April 2023.  The report provides an overview of the US biosimilar market and details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

The Q2/2026 edition reports that, as of March 2026, the FDA has approved 92 biosimilars across 20 unique biosimilar molecules, 67 of which have been launched in the US.  This is an additional 2 biosimilars approved and 3 launched since Q1/2026.  The biosimilars FDA approved in Q1/2026 were Accord Biopharma’s Filkri™ (filgrastim) (referencing Amgen’s Neupogen®) and Teva Pharmaceutical’s Ponlimsi™ (denosumab) (referencing Amgen’s Prolia®)  The Q1/2026 launches were Samsung Bioepis’ Ospomyv® (denosumab) (referencing Amgen’s Prolia®) and Gedeon Richter/Hikma’s Enoby® and Xtrenbo® (denosumab) (referencing Amgen’s Prolia® and Xgeva®, respectively).

Samsung Bioepis reports as “key highlights” increases in US market share of adalimumab biosimilars (to 60% as of February 2026), and ustekinumab biosimilars (an increase of 8% to 27% as of Q4/2025).  The increase in adalimumab biosimilar adoption is said to reflect the inclusion of Quallent private label sales in market share calculations beginning in 2026.

The Biosimilar Market Report summarises the FDA’s October 2025 and March 2026 draft guidance regarding streamlining biosimilar development, including by indicating that Clinical Efficacy Studies (CES) are no longer expected by default and clarifying that clinical data generated using a non-US-licensed comparator product may be used to support a US biosimilar application, provided sufficient scientific justification is established.  The Report concludes that reduced reliance on CES and increased flexibility in comparator sourcing “may lower development cost and complexity” and “may enable development across a broad set of reference products particularly in later-wave or smaller markets”.  However, the Report refers to market research suggesting that reduced reliance on CES is unlikely to materially impact coverage or formulary positioning, as FDA approval is viewed as the threshold for equivalence.

On 27 April 2026, Sun Pharmaceutical Industries Limited and Organon & Co announced that they have entered into a definitive agreement for the acquisition by Sun Pharma of all outstanding shares of Organon in an all-cash transaction valued at US$11.75 billion.

The transaction is expected to close in early 2027, subject to closing conditions including regulatory approvals and Organon stockholder approval.  The transaction will be “effected by a merger of Organon with a subsidiary of Sun Pharma, with Organon surviving the merger”.

According to the companies, the acquisition of Organon will result in Sun Pharma being among the top 25 global pharmaceutical companies with combined revenue of US$12.4 billion and will enable Sun Pharma’s entry into biosimilars as a “Top 10 global player”.

Biosimilars in Organon’s portfolio include Brenzys® (etanercept), Hadlima® (adalimumab) and Renflexis® (infliximab).  Organon also has exclusive global commercialisation rights to Bilprevda® and Bildyos®/Tuzemty® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), and Poherdy® (HLX11), biosimilar to Genentech/Roche’s Perjeta® (pertuzumab), for all countries except China, Hong Kong, Macau and Taiwan, under a June 2022 licence agreement between Organon and Shanghai Henlius Biotech.  Bilprevda® and Bildyos® have been approved in the US (September 2025), EU (September 2025), and Canada (March 2026).  Poherdy® was approved by the FDA in November 2025 and received a positive CHMP opinion in early 2026.

In March 2026, Sun Pharma launched its generic semaglutide products, Noveltreat™ and Sematrinity™ (semaglutide), in India.  The products are indicated for chronic weight management and type 2 diabetes mellitus, respectively.

On 24 April 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its April 2026 meeting, including positive opinions for one biosimilar and for extended indications of 9 already approved medicines.

Intas’ Rexatilux® (ranibizumab), biosimilar to Genentech’s Lucentis®, was the only biosimilar to receive a positive CHMP opinion in April.  It will join a number of ranibizumab biosimilars approved and launched in Europe, including Samsung Bioepis’ Byooviz® (approved August 2021 in vial form and commercially available in several European countries since March 2023), STADA/Xbrane’s Ximluci® (launched in the EU in April 2023, following November 2022 approval), Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva), and Sandoz/Lupin’s Ranluspec® (approved February 2026, with planned EU launch in the second half of 2026).

CHMP positive opinions for extended indications include the following for BMS’ Opdivo® (nivolumab): in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL).  The same indication was approved by the FDA in March 2026.  BMS also added a cHL indication to its European registration in March 2026, with approval for nivolumab in combination with brentuximab vedotin for the treatment of relapsed or refractory cHL after one prior line of therapy.  A number of nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.

AbbVie’s Skyrizi® (risankizumab) also secured a positive recommendation for an extended indication, in respect of paediatric plaque psoriasis.  The last indication approved for Skyrizi® in Europe was in July 2024, with ulcerative colitis being added to adult plaque psoriasis, psoriatic arthritis and moderate to severe Crohn’s disease.  There have not been any announcements of any significant biosimilar risankizumab development.

On 22 April 2026, Amneal Pharmaceuticals and Kashiv BioSciences jointly announced that Amneal will acquire 100% of Kashiv BioSciences.  The deal (which is subject to approval by Amneal shareholders and regulatory authorities) is expected to close in the second half of 2026.

The acquisition includes a USD $375 million cash transaction and USD $375 million in equity payable at closing, with up to USD $350 million based on achievement of certain regulatory milestones, potential royalties based on commercial milestones, and funding of operations through closing.

The acquisition will combine Kashiv’s expertise in biosimilar development and manufacturing with Amneal’s scale and commercialisation capabilities.  Kashiv and Amneal have previously entered strategic partnerships in relation to biosimilars in the US, including Fylnetra™ (biosimilar pegfilgrastim) in May 2022 and ADL018 (biosimilar omalizumab) in 2024.

In addition to Fylnetra™ and ADL018, Kashiv’s biosimilar pipeline includes Releuko™ (filgrastim-ayow) (FDA-approved March 2022), abatacept/KSHB002 (in clinical trials), certolizumab pegol and nivolumab (pre-clinical) and pembrolizumab (cell line and process development).  Amneal’s biosimilar pipeline includes Alymsys® (bevacizumab) (FDA approved April 2022).  Amneal also holds the exclusive US rights to mAbxience’s Boncresa™ and Oziltus™ (MB09), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively (FDA approved December 2025).

On 22 April 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the FDA for the treatment of children aged 2 to 11 years with chronic spontaneous urticaria (CSU) and inadequate response to histamine-1 antihistamine (H1AH) treatment.  This approval is the fifth indication of Dupixent® for young children in the US and follows EU approval for the same indication earlier this month.

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.  In January 2026, Chong Kun Dang received approval from the EMA and UK MHRA for its phase 1 clinical trial protocol for CKD-706 (dupilumab).

On 17 December 2025, Bristol Myers Squibb announced that Canada’s Drug Agency (CDA-AMC) has issued a positive reimbursement recommendation for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for the first-line treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) who meet certain criteria.

The combination of Opdivo® plus Yervoy® has been approved for a range of cancer treatments including for:

• Colorectal cancer in Australia, Canada, Europe, Japan, USA; and
• Hepatocellular carcinoma in Canada, Europe, Japan, Korea, Taiwan,

A number of nivolumab biosimilars are under development including Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.  In August 2025, Sandoz wound down its Phase III trial of JPB898 as a measure to streamline its biosimilar nivolumab development program following feedback from regulatory authorities regarding requirements for biosimilar approvals.

On 21 April 2026, Celltrion announced that the intravenous (IV) formulation of Steqeyma® (ustekinumab), biosimilar to Janssen’s Stelara®, has been approved in Japan.  The newly approved formulation adds to Celltrion’s subcutaneous (SC) formulation of Steqeyma®, which was launched in Japan in July 2025 following its March 2025 approval.

Both formulations of Steqeyma® are approved in Japan for psoriasis and psoriatic arthritis, with the IV formulation additionally approved for Crohn’s Disease.

Celltrion’s SC formulation of Steqeyma® was the third ustekinumab biosimilar launched in Japan, following Alvotech/Fuji Pharma’s launch of AVT04 in May 2024 and Biocon/Yoshindo’s Ustekinumab BS Subcutaneous Injection, launched in May 2025.  Samsung Bioepis received Japanese approval for its ustekinumab biosimilar, Nipro™, in December 2025.

Steqeyma® has been launched around the world including in the US (March 2025), Europe (November 2024), and Australia (listed on the PBS from 1 August 2025).

On 21 April 2026, Roche announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of systemic lupus erythematosus (SLE).  According to Roche, if Gazyva®/Gazyvaro® is approved, it will be the first anti-CD20 therapy to directly target B cells in SLE.

The sBLA was based on positive results from the Phase III ALLEGORY trial, which was a double-blind, placebo-controlled parallel-group study with 303 patients.  The Phase III results demonstrated significant reduction in disease activity compared to a placebo in patients with SLE.  The safety was consistent with the previously characterised profile of Gazyva®/Gazyvaro®.

Gazyva®/Gazyvaro® was FDA-approved in October 2025 for the treatment of active lupus nephritis (LN) in eligible adult patients.  The product is also approved in 100 countries for the treatment of haematological cancers.

On 21 April 2026, Biocon announced that, on 3 April 2026, Health Canada approved Bosaya™ and Vevzuo™, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively.  Bosaya™ is approved as a 60mg/mL PFS, while Vevzuo™ is approved as a 120 mg/1.7mL single-dose vial.  No Canadian launch date has been announced.

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 Canadian approvals of Celltrion’s Stoboclo® and Osenvelt® (September 2025) and Henlius/Organon’s Bildyos® and Tuzemty® (HLX14) (March 2026).  Apotex’s Denoza™, biosimilar to Amgen’s Prolia®, received Canadian approval in early April 2026.

The Canadian approval of Bosaya™ and Vevzuo™ comes just weeks after Biocon’s denosumab biosimilars were launched in the US, under the names Bosaya™ and Aukelso™.  Biocon entered into a settlement and licence agreement with Amgen on 1 October 2025, which permitted Biocon’s US launch of the denosumab biosimilars from 1 October 2025.