On 4 July 2025, The Bio reported that Korea’s Ministry of Food and Drug Safety has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab).  The trial will evaluate and compare the efficacy and safety of Darzalex® and CT-P44 over a two-year period in 486 patients with relapsed or refractory multiple myeloma.

In December 2024, Celltrion announced that the US FDA approved its IND application for a global Phase 3 clinical trial of CT-P44, which followed its European IND submission and entry into the global Phase 3 trial in November 2024.

Shanghai Henlius has a daratumumab biosimilar in development, announcing in February 2025 that it entered into a licence agreement with Dr. Reddy’s for HLX15.  In June 2024, Henlius announced the completion of Phase 1 clinical trials of HLX15, demonstrating that HLX15 has similar pharmacokinetic characteristics, and comparable safety and immunogenicity profiles to Darzalex®.

Over the last week, the European Commission (EC) has approved denosumab biosimilars for three sponsors:

• Gedeon Richter’s Junod® and Yaxwer® (announced 1 July 2025);
• mAbxience’s Izamby® and Denbrayce® (announced 2 July 2025); and
• Biocon’s Evfraxy® and Vevzuo® (announced 3 July 2025).

The biosimilars all received positive CHMP opinions in April 2025.

Richter’s and Biocon’s denosumab biosimilars are approved for the same indications as Amgen’s Prolia® and Xgeva®, respectively.  mAbxience’s Izamby® is approved for one of Prolia®’s indications (treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures), while the indications for Denbrayce® mirror those of Xgeva®.

There are now 6 sponsors with denosumab biosimilars approved in Europe, with previous approvals for Celltrion’s Stoboclo® and Osenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024).  Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025 and the EMA has accepted denosumab biosimilar MAAs including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

On 2 July 2025, The Economic Times reported that Aurobindo Pharma’s wholly owned subsidiary, CuraTeq Biologics, has received marketing approval from the European Commission for Dazublys®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab).  The authorisation follows the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) of Dazublys® for the treatment of HER2-positive breast or gastric cancers.

Samsung Bioepis’ Ontruzant® was the first trastuzumab biosimilar to be approved in the EU (November 2017), while Mylan/Biocon’s Ogivri® was the first to be approved in the US (December 2017).

On 2 July 2025, Sunshine Biopharma announced that its wholly owned Canadian subsidiary, Nora Pharma, has launched Niopeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim) in Canada.  Niopeg® was approved by Health Canada in April 2024 in pre-filled syringe of 6mg/0.6 ml.

The first pegfilgrastim biosimilar approved in Canada was Apotex’s Lapegla® in June 2018.  Shortly after, Mylan/Biocon’s Fulphila® (pegfilgrastim) was approved in the US (June 2018) and Accord Healthcare’s Pelgraz (pegfilgrastim) was approved in the EU (September 2018).

On 2 July 2025, Navlin Daily reported that the Spanish Ministry of Health issued a tender for the sustainable supply of biologics and biosimilars under a two-year Framework Agreement worth €411 million coordinated by the Instituto Nacional de Gestión Sanitaria (INGESA).

According to the report, this second-phase agreement builds upon the initial framework launched in late 2022, which generated over €120 million in cost savings to date.  The new agreement is expected to deliver an additional €178 million in savings and will comprise 17 therapeutic categories covering biologics that have approved biosimilars.  The Framework Agreement includes the following biologics, among others: adalimumab, etanercept, infliximab, rituximab, trastuzumab, pegfilgrastim, bevacizumab, tocilizumab, natalizumab, eculizumab, ranibizumab and ustekinumab.

INGESA will select between 25 and 50 suppliers using an open procedure, with contracts awarded based on 70% price and 30% quality weighting.

On 2 July 2025, Apotex announced that Aflivu™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), has been approved by Health Canada in pre-filled syringe and vial formats.  Aflivu™ is indicated for the treatment of nAMD, macular oedema secondary to retinal vein occlusion, diabetic macular oedema and myopic choroidal neovascularisation.

In August 2023, it was reported that Sam Chun Dang Pharm licensed its aflibercept biosimilar, SCD411, to Apotex for Canada.  Apotex’s announcement regarding the approval of Aflivu™ does not indicate whether this is the Sam Chun Dang developed biosimilar.  However, Sam Chun Dang announced on 2 July 2025 that SCD411 received product approval from the Canadian Ministry of Health on 26 June 2025 and that sales will commence in July 2025.

The announcements from Apotex and Sam Chun Dang follow closely behind the June approval of Biocon’s Yesafili™, which was reported to be the first aflibercept biosimilar approved in Canada.  Yesafili™ was due to be launched in Canada on 4 July 2025, as a result of a March 2024 settlement between Biocon and Regeneron/Bayer.

The only aflibercept biosimilar currently available in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar.  Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (in June 2025).

While there are a number of aflibercept biosimilars approved in Europe, there have been no announcements to date that any of them have launched, although Sandoz has indicated that the European launch of its biosimilar, Afqlir® (EU-approved in November 2024), is expected in Q4 2025.  In Australia, Regeneron and Bayer have commenced court proceedings against Sandoz, seeking to prevent the Australian launch of Afqlir®, scheduled for December 2025.

On 1 July 2025, Sandoz announced that it has commenced construction of a new biosimilar production centre in Brnik, Slovenia, due to open in 2028.  Sandoz is investing USD 440 million in the project, which is intended to expand Sandoz’s European biosimilar hub and increase its global market reach.

The new facility will focus on the production of injectable products for Sandoz’s existing and upcoming portfolio of biosimilars and will include preparation, filling, assembly and packaging of sterile injectable products, together with laboratories for quality control.

The project will bring Sandoz’s total planned investment in Slovenia to more than USD 1.1 billion by 2029, with the company previously investing in a biosimilar drug substance centre in Lendava and a biosimilar development centre in Ljubljana.

Sandoz recently launched the first denosumab biosimilars on the US market (Jubbonti® and Wyost®, 2 June 2025) and launched biosimilar ustekinumab in the US in February 2025 (Pyzchiva®, developed by Samsung Bioepis, EU launch in July 2024).  Sandoz currently has a number of biosimilars under development, including nivolumab, ipilimumab, pembrolizumab and ocrelizumab.

On 1 July 2025, Formycon announced that Bioeq AG, which holds the exclusive worldwide commercialisation rights for Formycon’s FYB201, biosimilar to Genentech’s Lucentis® (ranibizumab), has entered into an exclusive partnership with African biotechnology company Bio Usawa Biotechnology Ltd.  The partnership gives Bio Usawa the exclusive rights to commercialise FYB201 under the brand name BioUcenta™ in Sub-Saharan Africa.

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).

Last month, Brazil’s ANVISA had granted marketing authorisation for Ranivisio® (FYB201), with an expected launch in Q4 2025 by Formycon’s commercialisation partner, Biomm, and then a phased market rollout of Ranivisio® 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.

On 1 July 2025, Pharma Japan reported that Celltrion will launch Steqeyma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Japan on 8 July 2025.

Celltrion’s biosimilar ustekinumab launch follows Alvotech/Fuji Pharma’s launch of AVTO4 (ustekinumab) in May 2024 and Biocon/Yoshindo’s Ustekinumab BS Subcutaneous Injection, launched in May 2025.

Samsung Bioepis may be next in line, following its announcement on 9 June 2025 that it had entered into a partnership agreement with NIPRO Corporation in Japan for multiple biosimilars, including SB17, Samsung Bioepis’ ustekinumab biosimilar.

Celltrion’s Steqeyma® was launched in the US in March 2025 and in the EU in November 2024.

On 1 July 2025, Fresenius Kabi announced the US launch of Conexxence® and Bomyntra®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.  Fresenius’ denosumab biosimilars are the second to launch in the US, following the 2 June 2025 launch of Sandoz’s Wyost® and Jubbonti®.

The launch of Conexxence® and Bomyntra® follows a global settlement agreement between Fresenius Kabi and Amgen, resulting in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen in October 2024.  The global settlement permits European launch of the products “later in H2 of 2025”, subject to regulatory approvals.  The US launch of Sandoz’s denosumab biosimilars similarly followed a settlement of US patent litigation commenced by Amgen.

There are currently two other sponsors with denosumab biosimilars approved in the US, which have not yet launched: Celltrion (Stoboclo® and Osenvelt®, approved March 2025), and Samsung Bioepis (Ospomyv™ and Xbryk™, approved February 2025). Amgen settled denosumab patent litigation against Celltrion in January 2025, permitting US launch of Celltrion’s Stoboclo® and Osenvelt® from 1 June 2025 (although launch has not yet occurred).  BPCIA litigation commenced by Amgen against Samsung Bioepis regarding denosumab biosimilars remains pending.

Amgen also has pending US BPCIA litigation against Samsung Bioepis, Accord/Intas, Hikma/Gedeon Richter and Shanghai Henlius/Organon, and Biocon, which have all had denosumab biosimilar applications accepted for review by the FDA.