On 5 June 2025, Formycon announced that Brazil’s ANVISA has granted marketing authorisation for Ranivisio® (FYB201), biosimilar to Genentech’s Lucentis® (ranibizumab).

Formycon expects that Ranivisio® will be launched in Brazil in Q4 2025 by its commercialisation partner, Biomm, with a phased market rollout of Ranivisio® to follow across Latin America.  Marketing authorisations have previously been granted in Peru, El Salvador, Honduras and the Dominican Republic and further approvals in Central and South America are planned.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics).  It has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), the EU (in August 2022, marketed as Ranivisio® by Teva), Canada (in December 2023, marketed as Ranopto™ by Teva) and MENA (marketed as Ravegza® by MS Pharma).

On 4 February 2025, Genentech (a member of the Roche group) announced that the US FDA approved a new indication for Susvimo® (ranibizumab, 100mg/ml injection).  Susvimo® is the first and only approved continuous delivery treatment for diabetic macular oedema (DME), the leading cause of diabetes-related blindness.  Susvimo® is a refillable ocular implant containing a specialised formulation of ranibizumab.

The FDA’s approval was based on positive one-year results from the Phase 3 Pagoda study, a multicentre, randomised, active treatment-controlled, non-inferiority US-based Phase 3 study.  This study evaluated the efficacy, safety and pharmacokinetics of Susvimo® 100 mg/mL refilled every 6 months compared with monthly ranibizumab 0.5 mg intravitreal injections.

The approval follows the FDA’s acceptance of the supplemental BLA for Susvimo® in DME and diabetic retinopathy in July 2024.

The FDA had first approved Susvimo® in October 2021.  However, in October 2022, Genentech launched a voluntary recall after test results showed some implants did not perform to Genentech’s standards.  Genentech has since updated the Susvimo® implant and refill needle.  DME is the second indication approved for Susvimo®, after the FDA approved its relaunch for nAMD in July 2024.

On 18 December 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the May 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting.  

The May 2025 agenda lists 8 biologics for consideration, 3 of which are listed for new PBS additions:  

New listing applications

• UCB’s Bimzelx® (bimekizumab) moderate to severe hidradenitis suppurativa
• AstraZeneca’s Imjudo® (durvalumab) in combination with tremelimumab for the first line treatment of patients with advanced (unresectable) Stage B Barcelona clinic liver cancer or Stage C hepatocellular carcinoma.
• Accelagen’s Briumvi® (ublituximab) for relapsing-remitting multiple sclerosis

Amendment applications

• GSK’s Jemperli® (dostarlimab) for use in combination with platinum-containing chemotherapy for the treatment of primary advanced or first recurrent mismatch repair proficient endometrial cancer
• Janssen’s Tremfya® (guselkumab) for severe chronic plaque psoriasis
• Novartis’ Xolair® (omalizumab) for CRSwNP
• Novartis’ Lucentis® (ranibizumab) for proliferative diabetic retinopathy
• AstraZeneca’s Enhertu® (trastuzumab deruxtecan) for gastric or gastroesophageal junction cancer

In November 2024, PBAC previously published its agenda for the March 2025 meeting, which will consider 23 monoclonal antibodies, including four biosimilars. 

On 30 October 2024, Sandoz announced its Q3 and 9-month 2024 financial results, reporting third quarter net sales of USD 2.6 billion, up 12% in constant currencies, year-on-year.  Net sales for the first 9 months of the year were USD 7.6 billion, an increase of 9% in constant currencies compared to the same period in 2023.

Sandoz experienced strong biosimilars growth of 37% (to USD 741 million) and 32% (to USD 2.1 billion) in constant currencies (YoY) for the quarter and the year to date respectively.  This is attributed to the European launches of Pyzchiva® (ustekinumab) in July 2024 and Tyruko® (natalizumab) in January 2024, the Canadian launch of Wyost®/Jubbonti® (denosumab) in August 2024, the acquisition of Cimerli® (ranibizumab) from Coherus announced in January 2024, the uptake of Hyrimoz® (adalimumab) in the US and the continued strong demand for Sandoz’s very first biosimilar Omnitrope® (somatropin).

Key biosimilar milestones for Q3/2024 are reported to include the FDA approvals of Enzeevu^TM (aflibercept) in August 2024 and Pyzchiva® (ustekinumab) in July 2024, and the launch of the first European biosimilar to Janssen’s Stelara®, Pyzchiva® (ustekinumab), in July 2024.  Sandoz intends to launch Pyzchiva® in the US in February 2025 in the first wave of biosimilars, while the US-launch of Enzeevu™ is dependent upon factors including the outcome of ongoing BPCIA litigation.

Formycon has announced its half-year financial results, reporting Group revenue of €26.9 million and a 2024 revenue forecast remaining between €55-€65 million, driven by its biosimilar pipeline and projects.

This includes the “strong performance” of FYB201, biosimilar to Lucentis® (ranibizumab), which is reported to have achieved over 45% market share in the US and a 79% share of the UK market based on indication-specific market volume.  FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics).  It has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024) the EU (in August 2022, marketed as Ranivisio® by Teva), Canada (in December 2023, marketed as Ranopto^TM by Teva) and MENA (marketed as Ravegza® by MS Pharma).

Formycon also highlights the June 2024 US approval of its FYB203 (Ahzantive®), biosimilar to Regeneron’s Eylea® (aflibercept).  Formycon expects European approval “by early 2025 at the latest”.

In July 2024, Formycon and its commercialisation partner, Fresenius Kabi, received a positive CHMP opinion for FYB202, biosimilar to J&J’s Stelara® (ustekinumab), to be marketed as Fymskina (by Formycon) and Otulfi (by Fresenius).  In March 2024 Formycon and Fresenius announced they reached a settlement with J&J regarding the commercialisation of FYB202 in Europe and Canada.  This followed a US settlement in August 2023, enabling US launch of FYB202 “no later than 15 April 2024”.

Also in July 2024, Formycon announced enrolment of the first patient in its Phase III trial for FYB206 (pembrolizumab), biosimilar to MSD’s Keytruda®.

Three undisclosed biosimilar candidates are reportedly in development by Formycon, referred to as FYB208, FYB209 and FYB210.

On 12 August 2024, Xbrane reported that it has commenced processes to out-license Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab), and XB003 (previously known as Xcimzane™, BIIB801), biosimilar to UCB’s Cimzia® (certolizumab pegol).  The out-licensing process is to ensure “financing until envisioned positive operational cash-flow in Q2 2025”, including following the termination of Xbrane’s commercialisation and licensing agreement with Biogen earlier this month in relation to XB003.

Xbrane reports that initial discussions have been held with interested parties regarding the out-licensing of XB003 and it expects a licence agreement to be signed by the end of October 2024 at the latest.  The out-licensing of Xcimzane™ is reportedly proving more difficult given likely high costs for phase 1 and 3 trials of the biosimilar.  Xbrane says that it is seeking a streamlined clinical development plan for Xcimzane™ from regulatory authorities in Europe and the US.

On 21 April 2024, Xbrane announced that the FDA issued a Complete Letter Response regarding its ranibizumab BLA.  Xbrane states it is working toward re-submitting the BLA for its ranibizumab biosmialr, Ximluci®, to FDA in Q4 2024.  Xbrane and STADA announced the continental European launch of Ximluci® in April 2023.

On 9 August 2024, Sandoz announced its Q2 2024 sales and financial results for half year ended 30 June 2024, reporting net sales of USD 2.6 billion for Q2/24, an increase of 9% when compared to the same quarter in 2023.  Net sales for biosimilars in the same period were USD 720 million, up 37% compared with Q2/23, with growth for the half-year of 29%.

Sandoz attributes its strong double-digit biosimilars growth in the first half of 2024 to: the uptake of Hyrimoz® (adalimumab) in the US; the acquisition of Cimerli®, biosimilar to Genentech’s Lucentis® (ranibizumab) announced in January 2024; the continued strong demand for its first-ever biosimilar, Omnitrope® (somatropin); and the European launch of Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri®, in January 2024.

Sandoz has achieved a number of key milestones in the first half of 2024, including the approvals of ustekinumab biosimilar, Pyzchiva® (developed by Samsung Bioepis), in the US (1 July 2024) and Europe (22 April 2024) and denosumab biosimilars, Wyost® and Jubbonti®, in the US and Europe (5 March 2024).  Sandoz reports the expected US launch date for Wyost®/Jubbonti® as Q2/25 and that for Pyzchiva® as Q1/25.  Pyzchiva® was launched in Europe in July 2024.

Sandoz has increased its full year 2024 net sales guidance from mid-single digit growth to mid-to high single digit growth.

On 5 August 2024, Lupin announced the successful completion of a global Phase III clinical study of LUBT010, its biosimilar to Genentech’s Lucentis® (ranibizumab).  The study showed that LUBT010 has comparable efficacy, safety and immunogenicity to Lucentis® in patients with wet AMD.  The Phase III study data will form part of Lupin’s application for marketing approval with the FDA and the EMA.

Lupin has been marketing LUBT010 in India under the brand name RaniEyes™ since 2022, following India’s Central Drugs Standard Control Organisation granting marketing authorisation for LUBT010 in July 2021.  In November 2023, Lupin announced it had executed an agreement with the pharmaceutical manufacturer Amman Pharmaceuticals Industries for exclusive marketing and commercialisation of a biosimilar to Lucentis® (ranibizumab) in the middle east region, including Saudi Arabia and UAE.

At its July 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for six biosimilars.   

Three are biosimilars to Janssen’s Stelara® (ustekinumab): Samsung Bioepis’ Eksunbi, Formycon’s Fymskina (FYB202) and Fresenius Kabi’s Otulfi (FYB202).  All are indicated for plaque psoriasis (adult and paediatric), psoriatic arthritis and Crohn’s disease, with Eksunbi and Fymskina additionally indicated for ulcerative colitis.  

These CHMP positive opinions follow earlier EU approvals with Alvotech/Stada’s Uzpruvo® approved in January 2024, Samsung Bioepis’ Pyzchiva® in April 2024, and Amgen’s WezenlaTM in June 2024.  On 1 July 2024, CHMP also recommended marketing authorisation for Celltrion’s Steqeyma® (CT-P47, ustekinumab).  Bio-Thera is behind the race on this molecule, announcing on 24 July 2024 that its MAA for BAT2206 (ustekinumab) was EMA accepted. 

Positive CHMP opinions were also adopted at the July 2024 meeting for Dr Reddy’s Ituxredi™, biosimilar to Genentech/Biogen’s Rituxan® (rituximab), Midas Pharma’s Ranibizumab Midas, biosimilar to Genentech’s Lucentis® (ranibizumab) and Prestige Biopharma’s Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab). 

In addition, CHMP adopted positive opinions for two innovator biologics, extended indications for five and issued a negative opinion for one, as reported here. 

On 18 July 2024, Roche announced that FDA has accepted its supplemental BLA for Susvimo®, a refillable ocular implant containing a specialised formulation of ranibizumab, for the treatment of diabetic macular oedema (DME) and diabetic retinopathy (DR).

This follows the FDA’s approval of the relaunch of Susvimo® for nAMD earlier this month.

Also on 18 July 2024, Roche announced two-year data from the Phase III Pagoda and Pavilion studies evaluating Susvimo® for DME and DR, with Susvimo® demonstrating sustained efficacy over that period and safety consistent with the known safety profile for Susvimo® in patients with DME and DR.