Other Updates

On 24 October 2025, Johnson & Johnson announced that the European Commission has approved a subcutaneous (SC) induction dose regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

This follows approval of the same induction regimen in the US one month earlier.  Tremfya® was approved by the UK’s MHRA for treatment of Crohn’s disease (IV and SC) and UC (IV) in May 2025, and has been approved for the same indications in the EU (Crohn’s (IV and SC), May 2025; UC (IV), April 2025).

On 16 October 2025, the CHMP announced the highlights of its October 2025 meeting, including a positive opinion for an indication extension to Tremfya® for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.  Tremfya® is already approved in Europe for moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.

Biosimilar development of guselkumab is underway.  In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the MENA region.  In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

On 24 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has approved Novo Nordisk’s Alhemo® (concizumab) for the prevention or reduction in the frequency of bleeding episodes (prophylaxis) in people aged 12 years and older with haemophilia A or B with inhibitors.  The market authorisation was granted on 6 October 2025.

In addition to the UK, Alhemo® is currently approved in Canada (March 2023), Australia (July 2023), Switzerland (August 2023), Japan (September 2023), the US (December 2024) and the EU (December 2024).

On 24 October 2025, IAM reported that the Munich Regional Court has granted Regeneron a permanent cross-border injunction against Formycon preventing launch of FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), across 20 countries.  The permanent injunction follows a cross-border preliminary injunction granted by the Court in September 2025, based on a finding of infringement by equivalence of Regeneron’s formulation patent, EP 2364691.

FYB203 received European marketing approval in January 2025 as Baiama® and Ahzantive®, and UK approval in February 2025.  FYB203 was developed by Formycon, and Klinge holds the exclusive commercialisation rights.  In mid-January 2025, Formycon/Klinge and Teva Pharmaceuticals entered a collaboration agreement for the semi-exclusive commercialisation of FYB203 (as Ahzantive®) in Europe (excluding Italy) and Israel.  On 17 September 2025, Formycon announced that Klinge had entered a semi-exclusive licence agreement with Horus Pharma, for the commercialisation of FYB203 (under the brand name Baiama®) in selected European countries.

The dispute between Regeneron/Bayer and Formycon in relation to FYB203 is not limited to Germany, with legal proceedings having been conducted in the US, UK, Italy, Belgium, the Netherlands, and France.  In the US, FYB203 is set to launch in Q4/2026 following settlement of BPCIA litigation between Formycon and Regeneron in October 2025.  Formycon may launch FYB203 in the UK in November 2025, following a February 2025 approval by the MHRA and a failed UK preliminary injunction application by Regeneron in October 2025 (subject to any appeal).

On 23 October 2025, Samsung Bioepis published its eleventh US Biosimilar Market Report, which has been released every quarter since April 2023.  The report details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

The Q4/2025 edition reports that, as of September 2025, the FDA has approved 80 biosimilars across 19 unique biosimilar molecules, 58 of which have been launched in the US.  This is an increase over Q3/2025, when there had been 75 biosimilar approvals and 52 US biosimilar launches.

The products FDA-approved since the Q3/2025 report are Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (HLX14), and Gedeon Richter/Hikma’s Enoby™ and Xtrenbo™ (RGP-14-P), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, and Biocon’s Kirsty™, biosimilar to Novo Nordisk’s Novolog® (insulin aspart).  The biosimilars launched since the last report are Fresenius Kabi’s Conexxence® and Bomyntra® and Celltrion’s Stoboclo® and Osenvelt®, each denosumab biosimilars, and Dong A ST/Meiji Seika Pharma/Accord’s Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).

Key highlights from the market report are said to include:

• Only a single biosimilar competitor to Regeneron’s Eylea® (aflibercept) is currently in the US market (Amgen’s Pavblu®, launched October 2024) offering a WAC discount of -12%. However, there are 4 approved aflibercept biosimilars: Biocon’s Yesafili® (due to launch H2/2026), Formycon/Klinge’s Ahzantive® (due to launch Q4/2026), Sandoz’s Enzeevu® (due to launch Q4/2026), and Samsung Bioepis’ Opuvzi® (currently subject to pending BPCIA litigation and a preliminary injunction).
• The market share for Novartis’ Lucentis® (ranibizumab) has increased to 90%, with the pause on commercialisation of Sandoz’s biosimilar, Cimerli®. The only other ranibizumab biosimilar on the US market is Samsung Bioepis’ Byooviz®.
• As at Q4/2025, the average ASP of trastuzumab biosimilars has dropped 19% compared with Q3/2025. According to the report, this is primarily driven by a sharp decline of ASP in Accord’s Hercessi®.

The report includes insights on how payers are preparing for the implementation of the Maximum Fair Price (MFP) policy established by the Inflation Reduction Act (IRA) of 2022.  The negotiated prices under the MFP for an initial tranche of ten drugs will take effect on 1 January 2026.  According to comments made in the report by Dr William Fleming, a former senior Medicare executive, the introduction of MFP is expected to produce “a mixed impact on biosimilar adoption” with lower negotiated prices for reference products potentially narrowing the incentive to switch in some cases, but there potentially being accelerated uptake for biosimilars that maintain a pricing advantage or offer greater contracting flexibility.

On 23 October 2025, Biocon Biologics announced that Health Canada has approved Biocon’s Yesintek™ and Yesintek™ IV (intravenous), biosimilars to Janssen’s Stelara® (ustekinumab), for moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and ulcerative colitis.

On 29 August 2024, Biocon announced that it signed a patent settlement and licence agreement with Janssen, which enables Biocon to commercialise Bmab 1200/Yesintek® in Canada, Japan (approved January 2025), Europe (approved February 2025) and the United Kingdom (approved May 2025) from an unknown date.  Yesintek® was approved in the US in early December 2024, and was subsequently launched in February 2025, following a US settlement entered in February 2024.

A number of other ustekinumab biosimilars have been approved and launched in Canada to date, including JAMP/Alvotech’s Jamteki® (approved November 2023, launched March 2024), Amgen’s Wezlana® (approved December 2023, launched March 2024), Celltrion’s Steqeyma® (approved July 2024, launched August 2024), Samsung Bioepis’ Pyzchiva™ (approved August 2024, not yet launched) and Fresenius’ Otulfi® (approved December 2024, launched May 2025).

On 21 October 2025, African biotechnology company Bio Usawa announced that the Rwanda Food and Drugs Authority has granted market approval for its BioUcenta™, biosimilar to Genentech’s Lucentis® (ranibizumab), making the product the first ranibizumab biosimilar approved in Africa.

Bioeq AG, which holds the exclusive worldwide commercialisation rights for Formycon’s FYB201, entered into an exclusive partnership with Bio Usawa for the commercialisation of FYB201 under the brand name BioUcenta™ in Sub-Saharan Africa.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics), and 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 (in March 2024, marketed as Ravegza® by MS Pharma).

On 21 October 2025, Xbrane announced that the FDA has issued a Complete Response Letter (CRL) regarding its biosimilar ranibizumab, referencing Genentech’s Lucentis®.  The CRL follows the December 2024 resubmission of the BLA after the FDA issued 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.

According to Xbrane, the “FDA conducted re-inspections during Q3 2025 of both production sites involved in production of drug substance and drug product respectively.  Thorough evidence on corrective actions to the respective observations was submitted by both production sites in due time to the FDA.”  However, in the latest CRL, the FDA refers to unresolved observations following the inspection at one of the production sites without further specification, with no other issues related to the BLA mentioned.

In the October announcement, Xbrane also says that it and its contract manufacturers “are now awaiting further communication from FDA” and will work with the production site to resolve the issues and allow re-submission of the BLA as soon as possible.

The 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, who will be responsible for commercialisation in the US under the Lucamzi™ brand.

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

On 21 October 2025, Formycon and Teva jointly announced the European launch of FYB201/Ranivisio®, biosimilar to Genentech’s Lucentis® (ranibizumab), in pre-filled syringe (PFS) presentation.  The product is the first biosimilar ranibizumab to be offered in a PFS presentation in Europe, and will launch first in France this month, with additional countries, including Germany, to follow in a staggered approach.

FYB201/Ranivisio® was first approved in Europe in August 2022, and was developed by Bioeq (a joint venture between Formycon and Polpharma Biologics), and has been commercialised in the region in vial, and now PFS form, by Teva since 2022.  It was approved in the UK (in May 2022, marketed as Ongavia® by Teva), the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), Canada (in December 2023, marketed as Ranopto™ by Teva) and MENA (in March 2024, marketed as Ravegza® by MS Pharma).

Other approved ranibizumab biosimilars include Samsung Bioepis’ Byooviz® (EU-approved in September 2021, FDA-approved in September 2021); Lupin’s biosimilar (being marketed in the EU by Sandoz); and STADA/Xbrane’s Ximluci® (EU-approved 9 November 2022).

On 20 October 2025, Teva announced that it has entered into a licensing agreement with Prestige Biopharma for the commercialisation of Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab), across a majority of European markets.

Under the agreement, Teva will market and distribute Tuznue® in a majority of European markets, while Prestige Biopharma will be responsible for production and supply through its EU-GMP-certified, high-tech facilities equipped with advanced single-use technology.  Tuznue® was approved by the European Medicines Agency in September 2024, following the adoption of a positive opinion in July 2024.

Samsung Bioepis’ Ontruzant® was the first trastuzumab biosimilar to be approved in the EU (November 2017), followed by Celltrion’s Herzuma® (February 2018), Amgen’s Kanjinti® (May 2018), Pfizer’s Trazimera® (July 2018), Biocon’s Ogivri® (December 2018), Henlius/Accord’s Zercepec® (July 2020), and Sandoz’s Herwenda® (November 2023).

On 20 October 2025, Regeneron announced that it has settled its BPCIA litigation with Celltrion in relation to Eydenzelt®/CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg).  Under the terms of the settlement, Celltrion is permitted to launch Eydenzelt® in the US on 31 December 2026.

The settlement follows FDA approval of Eydenzelt® on 10 October 2025.  This was the sixth aflibercept biosimilar to be approved in the US following: Sandoz’s Enzeevu™ (August 2024), Amgen’s Pavblu® (August 2024) Formycon/Klinge’s Ahzantive®/FYB203 (June 2024), Biocon’s Yesafili™ (May 2024) and Samsung Bioepis’ Opuviz™/SB15 (May 2024).

Amgen’s Pavblu® is the only aflibercept biosimilar to have launched in the US, in October 2024, following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen.  Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu® (June 2025), which remains pending.

Launches of other US-approved aflibercept biosimilars have been delayed by BPCIA litigation brought by Regeneron.  However, in addition to the Regeneron/Celltrion proceedings, the following litigation has now settled, with biosimilar launches scheduled for 2026:

• Biocon and Regeneron settled BPCIA litigation in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026 (or earlier under certain undisclosed circumstances); and
• Sandoz’s Enzeevu™ and Formycon’s Ahzantive® are set to launch in Q4/2026 (or earlier under certain undisclosed circumstances) after settlement and licence agreements were announced in September 2025 and October 2025, respectively.

A preliminary injunction was granted, and remains in place, preventing Samsung Bioepis’ US launch of biosimilar aflibercept (14 June 2024, upheld on appeal on 29 January 2025).