On 27 February 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended indication extensions for 6 medicines, 3 of which are biopharmaceuticals: Sanofi/Regeneron’s Dupixent®, MSD’s Keytruda® and Janssen’s Stelara®.

Sanofi/Regeneron’s Dupixent® (dupilumab) received a positive recommendation for the treatment of children aged 2 to 11 years with moderate to severe chronic spontaneous urticaria (CSU).  The existing CSU indication in Europe (approved in November 2025) covers adults and adolescents (12 years and above).  According to Regeneron’s press release, an sBLA has been accepted for review in the US seeking approval for Dupixent® in children aged 2 to 11 years with CSU, with a decision expected by April 2026.

The CHMP also recommended indication of MSD’s Keytruda® (pembrolizumab), in combination with paclitaxel (with/without bevacizumab), for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in certain adults.

Janssen’s Stelara® (ustekinumab) received a recommendation for a change to its indication for paediatric Crohn’s disease for children from 2 years of age, from the current indication of paediatric patients weighing at least 40 kg.

Biosimilar launches, approvals and/or development are well underway for each of dupilumab, pembrolizumab and ustekinumab:

• Companies with dupilumab biosimilars in development include Alvotech, Samsung Bioepis, Formycon, Mabwell, Chong Kun Dang. CSPC Pharmaceutical, and Bio-Thera Solutions.
• Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025).  Pembrolizumab biosimilars are also under development including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, BioNTech, Alvotech and Formycon.
• Ustekinumab biosimilars were launched in Europe in July 2024 by STADA/Alvotech (Uzpruvo®) and Sandoz (Pyzchiva®). Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).

On 3 October 2025, IP Australia delivered its decision in Samsung Bioepis’ opposition to the grant of Janssen’s AU2019346134 relating to a method of treating ulcerative colitis with Stelara® (ustekinumab).  IP Australia ruled that the patent application was invalid for lack of novelty and inventive step in light of prior art, including a clinical trial record.  Samsung Bioepis was unsuccessful on its third opposition ground, lack of support.

Janssen now has until 24 October 2025 by which to appeal the opposition decision to the Federal Court of Australia.  IP Australia has also given Janssen until 3 December 2025 to propose amendments to seek to overcome the deficiencies in the claims.

The IP Australia decision marks yet another success for Samsung Bioepis in its Australian litigation against Janssen regarding Janssen’s Australian ustekinumab patent portfolio for the treatment of ulcerative colitis.  On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016).  In an earlier victory for Samsung Bioepis, Janssen surrendered two innovation patents (AU 2023100041 and 2023100042).  The Janssen innovation patents all related to a method of treating ulcerative colitis with ustekinumab.

Samsung Bioepis’ Epyztek® (ustekinumab) was approved in Australia in October 2024 and was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.

The Australian ustekinumab legal actions are part of a global suite of actions between Samsung Bioepis and Janssen, with Samsung Bioepis having claimed victory in other key jurisdictions including:

• The Netherlands: the District Court of The Hague delivered its judgment in September 2025 in Samsung Bioepis’ revocation action against EP 3 883 606, finding that the patent is valid.
• UK: In a short decision published on 26 September 2024, Justice Meade of the High Court of Justice of England and Wales refused Janssen leave to appeal from a decision that the UK counterpart of Janssen’s European Patent No. EP 3883606, relating to the use of ustekinumab for treating ulcerative colitis, was invalid.
• Canada: On 29 October 2024, the Canadian Federal Court dismissed Janssen’s motion to add an infringement counterclaim against Samsung Bioepis in existing patent proceedings. Samsung Bioepis commenced proceedings against Janssen seeking to impeach (invalidate) Janssen’s CA Patent 3,113,837 for Stelara® (ustekinumab) in November 2023.
• EU: In April 2025, Samsung Bioepis successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s Supplementary Protection Certificates (SPC) by manufacturing and stockpiling Samsung Bioepis’ ustekinumab biosimilar, Pyzchiva®, for export outside the European Union.
• US: On 1 May 2025, Business Korea reported that, on 28 April 2025, Samsung Bioepis defeated Johnson & Johnson (J&J) and Janssen Biotech’s application for a preliminary injunction preventing US sales of the private label version of Samsung Bioepis’ ustekinumab biosimilar. J&J filed an appeal on 30 April 2025.
• Switzerland: The Swiss Federal Patent Court upheld Samsung Bioepis’ invalidity action against the Swiss and Liechtenstein part of Janssen Biotech’s European Patent 3883606. Janssen’s patent relates to the use of ustekinumab (the active ingredient in Stelara®) in the treatment of ulcerative colitis.

On 16 September 2025, First Word Pharma reported that Mitsubishi Tanabe Pharma Corporation’s (MTPC) contract with Janssen for co-promotion activities for Janssen’s Stelara® (ustekinumab) in Japan will end on 31 December 2025.

Under the co-promotion agreement, MTPC has been responsible for distribution of Stelara® in Japan, with both MTPC and Janssen jointly conducting promotion of Stelara® to healthcare professionals.  After 31 December 2025, Janssen will exclusively handle the sales, distribution, and information provision activities for Stelara® in Japan, with MTPC continuing the distribution of Stelara® bearing the MTPC name until the inventory is depleted.

This news follows a series of recent announcements by biosimilar competitors relating to the launch of ustekinumab in Japan, including:

• Celltrion’s launch of Steqeyma® (CT-P43), biosimilar to Stelara®, in Japan on 8 July 2025.
• Samsung Bioepis’ partnership agreement with NIPRO Corporation in Japan for multiple biosimilars, including SB17, Samsung Bioepis’ biosimilar to Stelara®.
• Biocon Biologics’ May 2025 announcement that Yoshindo, its commercial partner, launched Ustekinumab BS Subcutaneous Injection in Japan for treatment of psoriasis vulgaris and psoriatic arthritis.

On 10 September 2025, the District Court of The Hague delivered judgment in Samsung Bioepis’ revocation action against Janssen’s EP 3 883 606 (the Janssen Patent), ruling that the method of treatment patent is valid.  The Janssen Patent relates to the use of ustekinumab in the treatment of ulcerative colitis (UC).

Samsung Bioepis had challenged the validity of the Janssen Patent on the grounds of lack of novelty and lack of inventive step.  However, the challenge failed on both grounds, with the Dutch court upholding the validity of the Janssen Patent and ordering Samsung Bioepis to pay Janssen’s costs of the proceeding, estimated to date to be €190,000.  Samsung Bioepis has appealed the judgment.

Samsung Bioepis’ court action is the latest in a series of court actions in The Netherlands, including a case pending in the Dutch Supreme Court regarding an SPC waiver for producing a Stelara® biosimilar for export to third countries.  The Supreme Court hearing date is yet to be published.

The Dutch actions are part of a global suite of actions between Samsung Bioepis and Janssen, with Samsung Bioepis having recently claimed victory in other key jurisdictions including:

• UK: In a short decision published on 26 September 2024, Justice Meade of the High Court of Justice of England and Wales refused Janssen leave to appeal from a decision that the UK counterpart of Janssen’s European Patent No. EP 3883606, relating to the use of ustekinumab for treating UC, was invalid.
• Canada: On 29 October 2024, the Canadian Federal Court dismissed Janssen’s motion to add an infringement counterclaim against Samsung Bioepis in existing patent proceedings. Samsung Bioepis commenced proceedings against Janssen seeking to invalidate Janssen’s CA Patent 3,113,837 for ustekinumab in November 2023.
• EU: In April 2025, Samsung Bioepis successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s Supplementary Protection Certificates (SPC) by manufacturing and stockpiling Samsung Bioepis’ ustekinumab biosimilar, Pyzchiva®, for export outside the European Union.
• US: On 1 May 2025, Business Korea reported that, on 28 April 2025, Samsung Bioepis defeated Johnson & Johnson (J&J) and Janssen Biotech’s application for a preliminary injunction preventing US sales of the private label version of Samsung Bioepis’ ustekinumab biosimilar. J&J filed an appeal on 30 April 2025.
• Australia: On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016). The Court’s revocation orders, made before the scheduled end of the trial, bring to a conclusion the patent infringement proceedings commenced by Janssen Biotech (and Janssen-Cilag Pty Ltd) against Samsung Bioepis in August 2024.  The Janssen innovation patents all related to a method of treating UC with ustekinumab.
• Switzerland: The Swiss Federal Patent Court upheld Samsung Bioepis’ invalidity action against the Swiss and Liechtenstein part of Janssen Biotech’s European Patent 3883606. Janssen’s patent relates to the use of ustekinumab for treating UC.

On 12 August 2025, the Swiss Federal Patent Court upheld Samsung Bioepis’ invalidity action against the Swiss and Liechtenstein part of Janssen Biotech’s European Patent 3883606.  Janssen’s ‘606 patent relates to the use of ustekinumab (the active ingredient in Stelara®) in the treatment of ulcerative colitis.

The Swiss action is part of a global suite of actions between Samsung Bioepis and Janssen, with Samsung Bioepis having recently claimed victory in other key jurisdictions including:

• UK: In a decision published on 26 September 2024, Justice Meade of the High Court of Justice of England and Wales refused Janssen leave to appeal from a decision that the UK counterpart of Janssen’s European Patent No. EP 3883606, relating to the use of ustekinumab for treating ulcerative colitis, was invalid.
• Canada: On 29 October 2024, the Canadian Federal Court dismissed Janssen’s motion to add an infringement counterclaim against Samsung Bioepis in existing patent proceedings.  Samsung Bioepis commenced proceedings against Janssen seeking to invalidate Janssen’s CA Patent 3,113,837 for Stelara® (ustekinumab) in November 2023.
• EU: In April 2025, Samsung Bioepis successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s Supplementary Protection Certificates (SPC) by manufacturing and stockpiling Samsung Bioepis’ ustekinumab biosimilar, Pyzchiva®, for export outside the European Union.
• US: Business Korea reported that, on 28 April 2025, Samsung Bioepis defeated Johnson & Johnson (J&J) and Janssen Biotech’s application for a preliminary injunction preventing US sales of the private label version of Samsung Bioepis’ ustekinumab biosimilar.  J&J filed an appeal on 30 April 2025.
• Australia: On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016).  The Court’s revocation orders, made before the scheduled end of the trial, concluded patent infringement proceedings commenced by Janssen Biotech (and Janssen-Cilag Pty Ltd) against Samsung Bioepis in August 2024.  The Janssen innovation patents all related to a method of treating ulcerative colitis with ustekinumab.

On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016).  The Court’s revocation orders, made before the scheduled end of the trial, bring to a conclusion the patent infringement proceedings commenced by Janssen Biotech (and Janssen-Cilag Pty Ltd) against Samsung Bioepis in August 2024.  The Janssen innovation patents all related to a method of treating ulcerative colitis with ustekinumab.  The Court is yet to issue any reasons for judgment in these proceedings.

This is a second victory for Samsung Bioepis in Australia with the earlier January 2024 Federal Court of Australia patent proceeding concluding with Janssen surrendering the two innovation patents in suit.  These innovation patents again related to a method of treating ulcerative colitis with ustekinumab.

Samsung Bioepis’ ustekinumab biosimilar, Epyztek®, was approved in Australia in October 2024.  Other ustekinumab biosimilars approved in Australia are Celltrion’s SteQeyma®/CT-P43 (September 2024) and Amgen’s Ajemnye® (May 2024) and Wezlana® (January 2024).

Janssen’s Stelara® remains the only PBS-listed ustekinumab product at this stage.  Amgen’s Wezlana® was recommended for listing at the March 2024 PBAC meeting, but the company has advised that it is not proceeding in the PBS listing process at this time.  Celltrion’s SteQeyma® was recommended for PBS-listing at PBAC’s November 2024 meeting and Samsung Bioepis’ Epyztek® was recommended for PBS-listing at PBAC’s March 2025 meeting.

Samsung Bioepis has successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s Supplementary Protection Certificates (SPC) by manufacturing and stockpiling Samsung Bioepis’ ustekinumab biosimilar, Pyzchiva®, for export outside the European Union.

The Hague Court of Appeal confirmed that the SPC Regulation’s manufacture-for-export exemption did not require trade licences at the time of notification nor that the export countries be duty-free.  The Hague Court of Appeal therefore held that stockpiling for export was permissible under the exemption, facilitating a “Day-1 entry” – for generic and biosimilar medicines after the SPC expires – into the market of the intended export country.

Pyzchiva® was developed by Samsung Bioepis, and was approved in Europe in April 2024.  It is commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.  Sandoz launched Pzychiva® in Europe in July 2024, for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and paediatric plaque psoriasis.  Although Pyzchiva® was not the first approved ustekinumab biosimilar product in Europe (it followed approval of Alvotech/Stada’s Uzpruvo® in January 2024 and announcement of its launch on 22 July 2024), it was the first ustekinumab biosimilar to be available in all reference medicine strengths.

On 2 April 2025, Johnson & Johnson announced that the European Commission has approved Stelara® (ustekinumab) for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.

This follows the adoption of a positive opinion by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) for this indication of Stelara® in February 2025.

There are a number of ustekinumab biosimilars marketed in the EU, with three launched during 2024: STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024.  Previously approved ustekinumab biosimilars in Europe include Biocon’s Yesintek® (February 2025), Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).

At its February 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended expanded therapeutic indications for 16 medicines, including the following six biopharmaceuticals.

The CHMP adopted a positive opinion for an extended indication of Janssen’s Stelara® (ustekinumab) to children with Crohn’s disease weighing at least 40 kg.  The new indication will apply to Stelara® concentrate for solution for infusion and solution for injection in vial or pre-filled syringe.

Janssen also received positive CHMP opinions for Darzalex® (daratumumab), with the removal of a limitation that adult patients with newly diagnosed multiple myeloma to be treated must be “eligible for autologous stem cell transplant”, and Tremfya® (guselkumab), to include treatment of adults with ulcerative colitis.

AstraZeneca’s Imfinzi® (durvalumab) has received a positive recommendation for the new indication of treating adults with resectable NSCLC at high risk of recurrence.

The CHMP also adopted positive opinions for indication expansions to:

• Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan), to include treatment of adults with unresectable or metastatic HR-positive HER2-low or -ultralow breast cancer; and
• Roche’s Columvi® (glofitamab), to include treatment of adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified who are ineligible for autologous stem cell transplant.

In addition, after re-examining its initial opinion at MSD’s request, the CHMP confirmed its positive recommendation for an expanded indication for MSD’s Keytruda® (pembrolizumab) to include patients with unresectable non-epithelioid malignant pleural mesothelioma.  The positive recommendation was initially adopted in November 2024.

On 24 February 2025, Johnson & Johnson (J&J) and Janssen Biotech filed a complaint in the US District Court for the District of New Jersey alleging that Samsung Bioepis has breached a settlement and licence agreement entered in July 2023 (announced in November 2023), permitting Samsung Bioepis to launch Pyzchiva® (SB17) (ustekinumab), biosimilar to J&J/Janssen’s Stelara®, in the US from 22 February 2025.  The settlement agreement resolved pending US patent litigation between the companies at the time it was signed.

The complaint, filed the same day on which the US launch of Pyzchiva® was announced, claims that Samsung Bioepis has entered into an unauthorised sublicence with a private label provider.  While the private label provider has not been publicly identified, it is described in J&J’s complaint as a member of a vertically integrated health conglomerate that includes a health insurer, health care provider, pharmacy chain and pharmacy benefits manager (PBM).  According to J&J, the 2023 settlement agreement did not permit Samsung Bioepis to authorise the private label provider to launch in the US an additional, private label version of Pyzchiva®.

J&J is seeking a preliminary injunction preventing US sales of the private label version of Samsung Bioepis’ ustekinumab biosimilar and compensatory damages “in an amount to be determined at trial”.  Samsung Bioepis has not yet filed a defence.

Pyzchiva® was approved by the US FDA in July 2024 for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis.  It is commercialised in the US (and Europe and Canada) by Sandoz pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

J&J has previously entered into ustekinumab settlement agreements with Amgen (which launched its biosimilar, Wezlana®, in early January 2025 through Optum Health Solution’s private label subsidiary Nuvaila), Alvotech and Teva (Selarsdi® launched on 21 February 2025), Biocon (Yesintek™ launched on 24 February 2025), Celltrion (US licence date of 7 March 2025) and Fresenius Kabi and Formycon (US licence date no later than 15 April 2025).

Janssen and Samsung Bioepis remain in patent infringement litigation in Australia, with the trial scheduled in June 2025.  In October 2024, the Canadian Federal Court dismissed a motion by Janssen to add an infringement counterclaim in proceedings brought by Samsung Bioepis to invalidate one of Janssen’s Canadian patents covering ustekinumab.