On 29 July 2026, Alvotech announced that the US FDA has closed its inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland with the inspection classification “Voluntary Action Indicated (VAI)”.  The routine cGMP surveillance inspection was conducted in May 2026.

The VAI classification means objectionable conditions or practices were found during the inspection, however the FDA did not take or recommend any administrative or regulatory action.   Alvotech’s CEO, Lisa Graver, stated that “the actions we have taken have effectively addressed the observations identified”.

Alvotech resubmitted its BLAs for AVT05 (golimumab) and AVT06 (aflibercept) to the FDA in June 2026.  This followed the receipt of Complete Response Letters from the FDA for Alvotech’s golimumab, aflibercept, and denosumab (AVT03) BLAs in November 2025, December 2025 and January 2026, respectively, and a subsequent  “remediation project” undertaken by Alvotech to address the FDA’s comments.

On 23 July 2026, Accord BioPharma announced its US launch of Osvyrti® and Jubereq® (denosumab), interchangeable biosimilars to Amgen’s Prolia® and Xgeva®, respectively.  The denosumab biosimilars are the first products of Accord developed and manufactured “end to end” by its parent company, Intas Pharmaceuticals.

Osvyrti® and Jubereq® were approved by the FDA in November 2025.  Intas/Accord settled BPCIA litigation with Amgen in relation to the denosumab biosimilars in July 2025, with the settlement permitting their US launch from 1 October 2025 (subject to regulatory approval).  The US launch of the products comes over 7 months after their European launch in December 2025 (Jubereq® and Osvyrti® having been EU-approved in May 2025).

Denosumab biosimilars have been approved and launched around the world by a variety of sponsors.  In the US, this includes Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (approved February 2025, Ospomyv™ 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), Gedeon Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025; launched January 2026) and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).

On 22 July 2026, the Australian Pharmaceutical Benefits Advisory Committee (PBAC) published the agenda for its November 2026 meeting, with a number of biosimilars and biopharmaceuticals to be considered for reimbursement.

New Biosimilar Listings

PBAC will consider the following applications for reimbursement of biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) for the first time: Accord Healthcare’s Denolia® and Deskleta® in 60mg/1mL pre-filled syringe (PFS), and Dexeva® and Dostiva® in 120mg/1.7mL PFS (each TGA-approved in October 2025).

Amgen’s Prolia® and Xgeva® are now sponsored in Australia by Arrotex, following a 2024 deal between the companies.  Denosumab biosimilars currently listed on the Pharmaceutical Benefits Scheme (PBS) are Sandoz’s Wyost® and Jubbonti® (PBS-listed 1 August 2025), Amgen’s supplemental denosumab brands Corora® and Ganvado® (PBS-listed 1 September 2025, sponsored by Arrotex) and Celltrion’s Stoboclo® and Osenvelt® (PBS-listed 1 March 2026).

The following biosimilars to Genentech’s Lucentis® (ranibizumab) will also be considered at the November PBAC meeting:

• Actor Pharmaceuticals’ Raniviz® in 1.65mg/0.165mL PFS (TGA-approved in February 2026); and
• Generic Health’s Solentis® and Simulara® in 1.65mg/0.165mL PFS and 2.3mg/0.23mL PFS (not yet TGA-approved).

The only other approved ranibizumab biosimilar in Australia is Samsung Bioepis’ Byooviz® (approved August 2022), which is not currently PBS-listed.

Amended Biosimilar Listings

Amgen has submitted a request for a “broad listing” of Amgevita® (for the higher concentration forms recommended by PBAC at its March 2026 meeting: 20mg/0.2ml & 40mg/0.4ml PFS and 80mg/0.8ml pre-filled pen (PFP)) for the treatment of immune-mediated inflammatory disease.

Originator Biopharmaceuticals

MSD is requesting PBS listing of a new subcutaneous form of Keytruda® (pembrolizumab) (in two different strengths) under the same circumstances and for the same indications as the currently listed intravenous form.  The TGA approved both strengths of Keytruda SC™ (395mg/2.4mL and 790mg/4.8mL) on 23 July 2026.

Roche has resubmitted its request to list Susvimo® (ranibizumab), a solution for ocular implant (39.5mg/0.395mL), for the treatment of wet AMD.  This follows the PBAC’s decision against recommending PBS-listing of Susvimo® at its May 2026 meeting, on the basis that Roche was seeking TGA approval for an updated version of the port delivery system for the medicine.

Bayer has submitted a request to list high dose Eylea® (aflibercept, 8mg) in 114.3mg/mL intravitreal injection for the treatment of visual impairment due to macular oedema following branch or central retinal vein occlusion (RVO).  Eylea® 8mg has been PBS-listed for nAMD and diabetic macular oedema since 1 November 2024.

Dr Reddy’s Laboratories has submitted a request to list a new indication of Zytorvi® (toripalimab) in 240mg/6mL solution for IV infusion, in combination with chemotherapy, for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC).  Zytorvi® was first listed on the PBS on 1 December 2025 for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma.

On 26 June 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its June 2026 meeting, including positive opinions for two biosimilars and recommended indication extensions for a number of biopharmaceuticals.

Ascend GmbH (a subsidiary of Alkem Laboratories) secured a CHMP positive opinion for “Denosumab Ascend”, biosimilar to Amgen’s Xgeva® (denosumab).  In November 2025, Alkem’s subsidiary, Enzene, received a CHMP positive opinion for Osqay®, biosimilar to Amgen’s Prolia® (denosumab).  Enzene and Theramex entered into an agreement in 2021 under which Enzene will supply Theramex with its denosumab biosimilar for commercialisation in Europe, the UK, Switzerland and Australia.  Alkem and Ascend are currently parties to BPCIA litigation commenced by Amgen in November 2025 following the filing of Alkem/Ascend’s BLA for biosimilar denosumab in the US.

The second biosimilar to be recommended by CHMP at its June 2026 meeting was Qilu Pharma’s Nylaspeg™, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  The recommendation comes over 7 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.

CHMP’s June 2026 positive opinions for extended indications include:

• Janssen’s Stelara® (ustekinumab) for the treatment of moderately to severely active ulcerative colitis in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional therapy or a biologic.
• AstraZeneca/Daiichi Sankyo’s Datroway® (datopotamab deruxtecan) as a monotherapy, for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy; and
• Janssen’s Tecvayli® (teclistamab) in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

On 23 June 2026, Organon and Shanghai Henlius announced the Canadian launch of Bildyos® (denosumab injection, 60 mg/1 mL) and Tuzemty® (denosumab injection, 120 mg/1.7 mL), indicated for all approved reference indications of Amgen’s Prolia® and Xgeva®, respectively.

Bildyos® and Tuzemty® (HLX14) were approved in Canada in March 2026.  Organon was granted the exclusive commercialisation rights to Henlius’ denosumab biosimilars globally, “except for China; including Hong Kong, Macau and Taiwan”, under a June 2022 agreement.

Henlius/Organon have previously launched denosumab biosimilars in the US under the names Bildyos® and Bilprevda® (approved September 2025, launched October 2025).  Bildyos® and Bilprevda® were approved in the EU in September 2025.

Sandoz’s Wyost® (February 2024) and Jubbonti® (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), Apotex’s Denoza™, biosimilar to Amgen’s Prolia®, (April 2026) and Biocon’s Bosaya™ and Vevzuo™ (April 2026).

On 10 June 2026, GlycoNex announced that its denosumab biosimilar, SPD8, met the primary endpoint in a Phase 3 osteoporosis study conducted in Japan, demonstrating therapeutic equivalence to Amgen’s Prolia® (denosumab).  SPD8 was co-developed by GlycoNex with Mitsubishi Gas Chemical.

GlycoNex and Mitsubishi Gas Chemical plan to complete the clinical study report by the end of September 2026 and file marketing approval applications in Japan in Q3 2026, referencing both Amgen’s Prolia® and Xgeva®.  A regulatory filing in Taiwan is planned for 2027, with a target launch date by end-2027.

There is one approved denosumab biosimilar in Japan, Alvotech’s AVT03 (DENOSUMAB BS 120 mg/1.4 mL in a vial for subcutaneous injection; September 2025), biosimilar to Daiichi Sankyo’s Ranmark® (marketed in other countries as Amgen’s Xgeva®).

Denosumab biosimilars have been approved and launched around the world by a variety of sponsors.  In the US, this includes Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (approved February 2025, Ospomyv™ 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 9 June 2026, Mabpharm announced that China’s National Medical Products Administration (NMPA) has approved CMAB807 (Puboli®) (60 mg pre-filled syringe), biosimilar to Amgen’s Prolia®, for the treatment of osteoporosis in postmenopausal women at increased fracture risk, osteoporosis in men at high fracture risk, and glucocorticoid-induced osteoporosis.  The approval marks Mabpharm’s fourth marketed product in China.

Mabpharm also indicated that its CMAB807X (Leishu®), biosimilar to Amgen’s Xgeva®, targeting oncology indications, such as bone metastases and giant cell tumour of bone, is expected to receive approval in the near future.

Mabpharm’s growing commercial portfolio in China already includes Leiting® (infliximab; July 2021), Aomaishu® (omalizumab; May 2023) and Enlituo® (cetuximab; June 2024).

Mabpharm enters an increasingly competitive denosumab biosimilar landscape in China.  Earlier approvals include Mabwell’s Mailishu® (approved March 2024, referencing Xgeva®) and Maiweijian® (approved May 2026, referencing Prolia®), and Boan Biotech’s Boyoubei® (November 2022, referencing Prolia®) and Boluojia® (approved 2024, expanded May 2026, referencing Xgeva®).

On 29 May 2026, Boan Biotech announced that it has submitted Biologics License Applications (BLAs) to the FDA for two denosumab biosimilars: BA6101 (denosumab 60 mg) and BA1102 (denosumab 120 mg), biosimilars to Amgen’s Prolia® and Xgeva® respectively.  The BLAs seek approval for all indications of the reference products.

Days earlier, on 26 May 2026, Boan Biotech announced that China’s National Medical Products Administration (NMPA) approved its supplemental application for Boluojia® (BA11021) (denosumab injection 120 mg), biosimilar to Xgeva®, for the treatment of patients with bone metastases from solid tumours or multiple myeloma, to delay or reduce the risk of skeletal-related events (SREs), which include pathological fractures, spinal cord compression, and bone-directed radiation or surgery.  Boluojia® was first approved in China in May 2024 for the treatment of giant cell tumour of bone.

Boan Biotech’s Boyoubei® (BA6101) was approved in China in November 2022 and in Bolivia in January 2026.  In November 2025, Boan Biologics’ MAAs for BA6101 and BA1102 were accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA).  According to Boan Biotech, regulatory submissions for its denosumab biosimilars are also planned for Europe and Japan, among other regions.

Denosumab biosimilars have been approved and launched around the world by a variety of sponsors.  In the US, this includes Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (approved February 2025, Ospomyv™ 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 21 May 2026, Mabwell announced that China’s National Medical Products Administration (NMPA) approved an expanded set of indications for Maiweijian™, biosimilar to Amgen’s Xgeva® (denosumab), developed by its wholly-owned subsidiary T-mab.  The drug is now approved to help delay or reduce skeletal-related events, including pathological fracture, spinal cord compression, and the need for bone surgery or radiotherapy, in patients with bone metastases from solid tumours or multiple myeloma.

This builds on Maiweijian™’s initial NMPA approval in March 2024, when it became the first denosumab biosimilar (120mg) approved for marketing in China, initially indicated for unresectable giant cell tumour of bone.  Mabwell’s Mailishu®, biosimilar to Amgen’s Prolia® (denosumab), was approved by the NMPA in March 2023.

Mabwell announced in April 2026 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 is responsible for the registration and commercialisation of the denosumab biosimilars in Malaysia, while Mabwell is responsible for the development, manufacturing and supply of the biosimilars.

Mabwell completed its first commercial shipment of its denosumab biosimilars outside China in December 2025, although the destination(s) of the shipment was not disclosed in the press release.  According to Mabwell, it has submitted marketing authorisation applications for its denosumab biosimilars in several markets, including Jordan, Egypt, and Brazil.

On 12 May 2026, Celltrion announced that it has acquired a 100% stake in France-based healthcare firm, Gifrer.  Gifrer operates more than 9,000 pharmacy sales channels and supply networks covering about 800 hospitals across France and will continue to operate independently post-acquisition.

The acquisition is aimed at strengthening Celltrion’s access to French pharmacy channels as France expands pharmacist-led biosimilar substitution.  This includes anticipated approval for substitution of denosumab biosimilars later this year, with Celltrion planning to use Gifrer’s sales network to expand pharmacy sales for its denosumab biosimilars, Stoboclo® and Osenvelt®.

In addition, the acquisition expands Celltrion’s product portfolio beyond biopharmaceuticals, as Gifrer sells over 140 over-the-counter medicines and other health products.  Celltrion expects the acquisition to generate an additional 250 billion won in revenue over the next 5 years.