On 21 September 2026, Roche announced that the European Commission (EC) has approved Susvimo® (ranibizumab) as a 100 mg/mL solution for injection for the treatment of neovascular age-related macular degeneration (nAMD).

The European approval follows the CHMP’s positive opinion for Susvimo® in July 2026.  Susvimo® is delivered via an ocular implant, marketed as Contivue® in the EU, for continuous release into the vitreous of the eye.  The Contivue® devices include a refillable implant surgically inserted into the eye during a one-time, outpatient procedure.  Contivue® also includes four ancillary devices to initially fill, insert, refill, and remove the implant

Susvimo® was approved in the US for nAMD in July 2024, diabetic macular oedema in February 2025 and diabetic retinopathy in May 2025.  In the US, the devices and medicine (ranibizumab) are approved as a single product.

The US approvals followed an update and relaunch of the product, after Roche conducted a voluntary recall of the initial version (FDA approved in October 2021) as a result of test results showing some implants did not perform to Roche’s standards.

September 2026 has been a busy month for ranibizumab with two new registrations on the Australian Register of Therapeutic Goods (ARTG): Novartis’ Vurjor® (1.65mg/0.165mL solution prefilled syringe (18 September)) and Roche’s Susvimo® (100mg/mL solution for injection vial for use with the Contivue® ocular implant (24 September)).

Vurjor® is a new brand for Novartis, with all of Novartis’s previous ranibizumab ARTG registrations under its Lucentis® brand.  Novartis is yet to seek listing of Vurjor® on the Pharmaceutical Benefits Scheme (PBS).  Vurjor® is approved for the same indications as Lucentis® for the treatment of adults.

Roche’s Susvimo® is delivered via an ocular implant, marketed as Contivue®, for continuous release into the vitreous of the eye.  It is indicated for the treatment of adult patients with nAMD who have previously responded to at least two intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors.

Roche has applied to list Susvimo® on the PBS.  The Pharmaceutical Benefits Advisory Committee (PBAC) had previously decided 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.  Roche has resubmitted its request for PBS-listing of Susvimo®, which will be considered by PBAC at its November 2026 meeting.

There are currently two ranibizumab biosimilars approved in Australia: Actor Pharmaceuticals’ Raniviz® in 1.65mg/0.165mL PFS (TGA-approved in February 2026), and Samsung Bioepis’ Byooviz® (approved August 2022).  Actor has applied for PBS listing of its biosimilar ranibizumab, as has Generic Health in relation to Solentis® and Simulara® in 1.65mg/0.165mL PFS and 2.3mg/0.23mL PFS (not yet TGA-approved).  Those PBS applications will be considered at the November PBAC meeting.

On 24 July 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its July 2026 meeting, including positive opinions for one biosimilar and two biopharmaceuticals.

Aurobindo Pharma subsidiary, CuraTeQ Biologics, received a CHMP recommendation for Cavoley™, biosimilar to Amgen’s Neulasta® (pegfilgrastim), as 6 mg solution for injection in a pre-filled syringe.  CuraTeQ has previously had a pegfilgrastim biosimilar approved in the EU under the name Dyrupeg® (March 2025).  Although it has been over 7 years since the approval of the first European pegfilgrastim biosimilar (Accord Healthcare’s Pelgraz®, September 2018), companies continue to pursue pegfilgrastim biosimilars in Europe, with Qilu Pharma obtaining a positive CHMP opinion for Nylaspeg™ (pegfilgrastim) last month.

The CHMP has also recommended marketing authorisation for Roche’s Susvimo® (ranibizumab) as a 100 mg/ml solution for injection.  Susvimo® is delivered via an ocular implant (Contivue™) for continuous release into the vitreous of the eye for the treatment of nAMD.  Susvimo® was approved in the US for nAMD in July 2024 and for DME in February 2025.  The US approvals followed an update and relaunch of the product, after Roche conducted a voluntary recall of the initial version (FDA approved in October 2021) as a result of test results showing some implants did not perform to Roche’s standards.

A positive CHMP opinion was also adopted for LIB Therapeutics’ Lyrokaul® (lerodalcibep), a recombinant fusion protein containing a PCSK9 inhibitor, which is indicated for treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet.  The drug was launched in the US (under the name Lerochol®) in May 2026.

At its July 2026 meeting, the CHMP also recommended expanded indications for a number of medicines, including:

• AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) for unresectable or metastatic HER2 positive breast cancer (in combination with pertuzumab);
• Amgen’s Repatha® (evolocumab) for adults with established, or at high risk for, atherosclerotic cardiovascular disease; and
• Gilead’s Trodelvy® (sacituzumab govitecan), in combination with pembrolizumab, for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic disease and whose tumours express PD-L1 with a combined positive score ≥ 10.

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 1 July 2026, Samsung Bioepis and Harrow announced the relaunch of Byooviz® (ranibizumab), biosimilar to Genentech’s Lucentis®, in the US.

The relaunch follows the transition of Biogen’s commercialisation rights for biosimilar ranibizumab (and biosimilar aflibercept) back to Samsung Bioepis after Biogen terminated a November 2019 agreement with Samsung Bioepis for the US and Canada.  Samsung Bioepis entered into a partnership with Harrow in July 2025 for the US commercialisation of Byooviz® (and Opuviz® (aflibercept)) on full return of the commercial rights.

Byooviz® was approved in the US in September 2021 for the treatment of patients with neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, and myopic choroidal neovascularisation.  It was originally launched in the US in June 2022 and was granted interchangeability designation by the FDA in October 2023.

The following ranibizumab biosimilars are also approved in the US: Sandoz’s Cimerli® (August 2022, rights acquired by Sandoz from Coherus in March 2024), Formycon’s Nufymco® (December 2025) and Lupin’s Ranluspec® (June 2026).

On 2 June 2026, the FDA approved Lupin’s Ranluspec® (ranibiziumab-hkdz) as an interchangeable biosimilar of Genentech’s Lucentis®.  Ranluspec® is approved in both vial and pre-filled syringe presentations for the treatment of nAMD, macular oedema following retinal vein occlusion, diabetic macular oedema, diabetic retinopathy, and myopic choroidal neovascularization.

The following day, on 3 June 2026, Xbrane announced that the FDA accepted its biosimilar ranibizumab BLA, which has been given a Biosimilar User Fee Act (BsUFA) action date of 29 October 2026.  The ranibizumab biosimilar is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is the subject of an exclusive licensing agreement with Valorum Biologics, which will be responsible for commercialising the product in the US under the name Lucamzi™.

Xbrane resubmitted its BLA in April 2026 following an FDA Complete Response Letter (CRL) received in October 2025.  This was the second CRL issued in relation to Xbrane’s ranibizumab BLA following a first CRL in April 2024 identifying issues relating to (a) the analytical methods for the reference standard; and (b) pre-approval inspections of manufacturing partner’s sites.

The first ranibizumab biosimilar approved in the US was Samsung Bioepis’ Byooviz® (September 2021), followed by Sandoz’s Cimerli® (August 2022, rights acquired by Sandoz from Coherus in March 2024), and Formycon’s Nufymco® (December 2025).

Xbrane’s ranibizumab biosimilar has been approved in the EU and UK since November 2022, under the name Ximluci®, and was launched in the EU in April 2023.  Lupin’s Ranluspec® was approved in the EU in February 2026, where it is being commercialised by Sandoz under an August 2025 agreement.

On 22 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its May 2026 meeting, including positive opinions for one biosimilar, one “hybrid” medicine and recommended extended indications for a number of biopharmaceuticals.

Lupin’s Vislyfa® (ranibizumab), biosimilar to Genentech’s Lucentis®, was the only biosimilar to receive a positive opinion this month.  There is already a Lupin-developed biosimilar approved in Europe, Ranluspec® (approved February 2026, with planned EU launch in the second half of 2026). Under an August 2025 agreement, Sandoz is commercialising Ranluspec® in the EU (excluding Germany), Switzerland, Norway, Canada, Australia, Hong Kong, Vietnam and Malaysia.  Other ranibizumab biosimilars approved and launched in Europe include Samsung Bioepis’ Byooviz® (approved August 2021 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) and Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva).  Intas’ Rexatilux® (ranibizumab) received a positive CHMP opinion in April 2026.

STADA received positive recommendations for its “hybrid” liraglutide products Ablymico® and STADA Liraglutide™, indicated for weight management and type 2 diabetes, respectively.  The EMA categorises a medicine as “hybrid” where it is similar to an authorised medicine containing the same active substance, but where there are certain differences between the two medicines such as in their strength, indication or pharmaceutical form.  Ablymico® is a hybrid medicine of Novo Nordisk’s Saxenda® (liraglutide), in that it contains the same active substance, but it is chemically synthesised, whereas the active substance of Saxenda® is of biological origin.  For the same reason, STADA Liraglutide™ is a hybrid medicine of Novo Nordisk’s Victoza® (liraglutide).

The CHMP’s May 2026 positive opinions for extended indications include:

• AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan): for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options;
• Merck KGaA’s Erbitux® (cetuximab): for adults with BRAF V600E mutant metastatic colorectal cancer in combination with encorafenib and FOLFOX for first line treatment and in combination with encorafenib in patients who have received prior systemic therapy;
• AstraZeneca’s Fasenra® (benralizumab): as an add‑on treatment for adult and adolescent patients aged 12 years and older weighing at least 35 kg with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause;
• Shanghai Henlius/Accord’s Hetronifly® (serplulimab): in combination with carboplatin and nab-paclitaxel, for first-line treatment of adults with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma;
• MSD’s Keytruda® (pembrolizumab): in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for treatment of adults with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin‑containing chemotherapy;
• MSD’s Keytruda SC™ (pembrolizumab and berahyaluronidase-alfa): indications extended to adolescents in relation to melanoma and classical Hodgkin Lymphoma; and
• Astellas’ Padcev® (enfortumab vedotin): in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

Celltrion withdrew its EU marketing authorisation application for Veblocema™ (infliximab) for the treatment of rheumatoid arthritis, Crohn’s disease and ulcerative colitis “due to a change in business strategy”, while Laboratoires Delbert withdrew its application for Orblid™ (bevacizumab) for treatment of hereditary haemorrhagic telangiectasia, due to identification of major clinical issues which could only be addressed by carrying out a new clinical study.

On 30 April 2026, Xbrane announced that it has resubmitted its BLA for biosimilar ranibizumab to the FDA following a Complete Response Letter (CRL) received in October 2025.  In November 2025, Xbrane had indicated that it expected to resubmit its BLA in March 2026.  However, following Xbrane’s contract manufacturer receiving “further detailed feedback from the FDA”, Xbrane’s resubmission plans were delayed.

The biosimilar to Genentech’s Lucentis® is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is the subject of an exclusive licensing agreement with Valorum Biologics, which will be responsible for commercialisation in the US.

There are currently three ranibizumab biosimilars approved in the US.  The first approved was Samsung Bioepis’ Byooviz® (September 2021), followed by Sandoz’s Cimerli® (August 2022, rights acquired by Sandoz from Coherus in March 2024) and Formycon’s Nufymco® (December 2025).

Xbrane’s ranibizumab biosimilar has been approved in the EU and UK since November 2022, under the name Ximluci®.  It was launched in the EU in April 2023.

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 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 October 2025.  In November 2025, Xbrane had indicated that it expected to resubmit its BLA in March 2026.  However, following Xbrane’s contract manufacturer receiving “further detailed feedback from the FDA”, Xbrane’s resubmission plans have now been delayed to April/May 2026.

According to Xbrane, following resubmission of the BLA for its biosimilar to Genentech’s Lucentis®, an FDA 6-month review process is likely, resulting in an expected Biosimilar User Fee Amendment (BsUFA) date in October/November 2026.

The ranibizumab biosimilar is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is the subject of an exclusive licensing agreement with US biosimilars specialist Valorum Biologics, which will be responsible for commercialisation in the US.

There are currently three ranibizumab biosimilars approved in the US.  The first approved was Samsung Bioepis’ Byooviz® (September 2021), followed by Formycon/Sandoz’s Cimerli® (August 2022) and Formycon’s Nufymco® (December 2025).

Xbrane’s ranibizumab biosimilar has been approved in the EU and UK since November 2022, under the name Ximluci®.  It was launched in the EU in April 2023.