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.

On 2 December 2024, Biocon Biologics announced that the FDA has approved its Yesintek® (ustekinumab-kfce), biosimilar to J&J’s Stelara® (ustekinumab).  Yesintek® joins five other previously FDA-approved Stelara® biosimilars: Formycon and Fresenius Kabi’s Otulfi® (September 2024), Alvotech and Teva’s Selarsdi™ (April 2024), Meiji Seika’s Imuldosa™ (October 2024), Samsung Bioepis’s Pyzchiva® (July 2024), and Amgen’s Wezlana® (October 2024).

Biocon can launch Yesintek® in February 2025 as agreed in a settlement deal between Biocon and J&J entered in February 2024.

We reported on 26 August 2024 that JAMP had filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara® (ustekinumab).  JAMP alleged that Janssen had abused its dominant market position, in contravention of section 79 of the Competition Act by “…gam[ing] the pharmaceutical regulatory system and use[ing] sham litigation to disincentivize rivals from launching their own ustekinumab drugs”.  JAMP’s application was the first leave application under the Competition Act’s abuse of dominance provisions to be determined by the Tribunal since the 2022 amendments allowed private parties to seek leave to bring such applications.

On 20 November 2024, the Canadian Competition Tribunal dismissed JAMP’s application for leave to bring an action under the Competition Act.  The Tribunal held that JAMP’s complaint failed due to a lack of “cogent” evidence to support its allegations that:

• Janssen had gamed the regulatory system and engaged in “sham” litigation;
• Janssen’s FINLIUS drug was a “fighting brand” as JAMP had presented no argument to suggest that it was forced out of the market by FINLIUS;
• Janssen had engaged in predatory pricing;
• Janssen had sent anti-competitive communications to physicians, insurers and patients; and
• Janssen’s conduct could have the effect of substantially lessening or preventing competition in the ustekinumab market.

In March this year, JAMP launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada.  The Alvotech-developed Jamteki^™ was approved by Health Canada in November 2023.  The March 2024 launch followed a settlement between Alvotech and J&J in February 2024 regarding ustekinumab.

In a short decision published on 26 September 2024, Justice Meade of the High Court of Justice of England and Wales has 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, is invalid.

The matter involves litigation brought by Samsung Bioepis seeking to invalidate the Janssen patent on the grounds of novelty and obviousness.  Janssen counter-claimed against Samsung Bioepis for patent infringement.  On 30 July 2024, Justice Meade issued a decision in Samsung Bioepis’ favour, holding that the Janssen patent is invalid for obviousness in light of a slide presentation entitled “Safety and efficacy of Ustekinumab Induction Therapy in Patients with Moderate to Severe UC: Results from the Phase 3 UNIFI Study” delivered at the October 2018 American College of Gastroenterology conference.

Justice Meade’s ruling against Janssen’s application for leave to appeal his decision is another resounding success for Samsung Bioepis.  Justice Meade stated that the key argument on which Janssen relied to seek leave to appeal had “no prospect of success” and it was “not legitimate to raise it at this stage.  If it was to have been taken, it could and should have been taken at trial”.

The matter will now return to court for Justice Meade to deal with costs and other consequential matters.

Samsung Bioepis’ ustekinumab biosimilar (SB17) was approved in Europe in April 2024 as Pyzchiva®. Pyzchiva® will be commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

On 24 September 2024, Alvotech submitted a Citizen Petition to the FDA requesting that the FDA refuse to designate any ustekinumab biosimilar as “interchangeable” with Janssen’s Stelara® that is manufactured using a CHO cell-line system, until the FDA has evaluated the differences in sialyation between the biosimilars and Stelara®.

The FDA will licence a biological product as “interchangeable” with a reference product if it is biosimilar and can be expected to produce the same clinical results as the reference product in any given patient.  In addition, there must be no greater risk to the patient in switching from the reference product to the proposed interchangeable version than would be involved in remaining on the reference product.

Alvotech’s Citizen Petition refers to US-approved ustekinumab biosimilars: Samsung Bioepis’ Pyzchiva® (SB17, July 2024), Alvotech/Teva’s Selarsdi™ (April 2024) and Amgen’s Wezlana® (October 2023).  The Petition claims that, like Stelara®, Selarsdi® and Wezlana® (both of which the FDA has already licensed as interchangeable ustekinumab biosimilars) are produced using a Sp2/0 host cell line or a glyco-engineered CHO cell-line system, whereas Pyzchiva® and other proposed biosimilars to Stelara® are manufactured using a CHO cell line-system, including Celltrion’s CT-P43/SteQeyma®.

If the FDA was to act on Alvotech’s submission, it would deny “interchangeability” status to Pyzchiva® and SteQeyma®, at least until it had investigated the claimed effects of differences in sialyation.

In its petition, Alvotech argues that the low sialylation of therapeutic proteins associated with CHO-based manufacturing (compared with production of monoclonal antibodies using Sp2) can significantly impact their pharmacokinetics (“PK”), particularly in terms of circulation time, immune clearance, and overall efficacy.  Alvotech claims that this means the clinical effects of CHO-derived biosimilars may be different over prolonged periods than Stelara® and those biosimilars manufactured in Sp2/0.  The Petition suggests such differences could impact dosing, efficacy, and safety profiles in ways that may not be fully captured by standard interchangeability studies.

On 29 August 2024, Biocon Ltd announced that it has signed a patent settlement and licence agreement with Janssen which enables Biocon to commercialise Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in Europe, the United Kingdom, Canada and Japan. Biocon has submitted regulatory applications in each of these jurisdictions.

The Biocon-Janssen patent settlement and licence agreement follows the US settlement agreement in February 2024 enabling Biocon to launch Bmab 1200 in the US in February 2025.  In May 2024, Biocon announced that the FDA accepted its BLA for Bmab 1200 for review under the 351(k) pathway.

Biocon reported in August 2024 year-on-year consolidated revenue growth of 30% for Q2 2024, with its biosimilars business delivering year-on-year growth of 11% compared with the same quarter last year.

JAMP recently filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara® (ustekinumab).  JAMP alleges that Janssen has abused its dominant market position, in contravention of section 79 of the Competition Act by “…gam[ing] the pharmaceutical regulatory system and use[ing] sham litigation to disincentivize rivals from launching their own ustekinumab drugs”.

If JAMP succeeds in its leave application, it intends to seek a range of orders designed to curb Janssen’s alleged anti-competitive conduct as well as an order for a monetary penalty 3 times the value of the benefit which Janssen has derived from alleged anti-competitive conduct, estimated by JAMP to be at least $1 trillion.

In March this year, JAMP launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada. The Alvotech-developed Jamteki^™ was approved by Health Canada in November 2023. The March 2024 launch followed a settlement between Alvotech and J&J in February 2024 regarding ustekinumab.

On 23 August 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its July 2024 meeting, recommending listing for one biosimilar, and three originator biopharmaceuticals.

The following biosimilars were recommended for listing on the Pharmaceutical Benefits Scheme (PBS):

• Sandoz’s Hyrimoz® (adalimumab) for the same indications as the currently PBS-listed reference biologic, Abbvie’s Humira®, and other brands of adalimumab.

In addition, the following originator biopharmaceuticals were recommended for PBS listing:

• Roche’s Vabysmo® (faricimab) for the treatment of retinal vein occlusion.
• AstraZeneca’s Lynparza® (olaparib) for the treatment of HER2-negative metastatic breast cancer for patients with a confirmed BRCA1 or BRCA2 mutation.
• Takeda’s Entyvio® (vedolizumab) for continuing treatment of chronic pouchitis.

PBAC reports that MSD’s Keytruda® (pembrolizumab) solution concentrate for IV infusion 100 mg in 4 mL has had its May 2022 recommendation extended for an additional 12 months.  Janssen’s Stelara® (ustekinumab) injection 90 mg in 1 mL pre-filled syringe has had its July 2022 recommendation rescinded.

In August 2024, we reported that a number of biopharmaceuticals and biosimilars are potentially in line for September listings on the PBS, including two biosimilars to Abbvie’s Humira® (adalimumab): Organon’s Hadlima® (adalimumab-bwwd) in 40 mg/0.4 ml PFP and Celltrion’s Yuflyma® (adalimumab-aaty) in 0.8 mg/0.8 ml PFN and PFS.

On 30 July 2024, Mr Justice Meade of the High Court of Justice of England and Wales delivered his decision in Samsung Bioepis UK Limited’s case against Janssen Biotech Inc seeking to invalidate the UK counterpart patent of European Patent No. EP 3883606 on the grounds of novelty and obviousness.  Janssen’s patent relates to the use of ustekinumab for the treatment of ulcerative colitis and Janssen had counter-claimed against Samsung Bioepis for patent infringement.

The decision is a resounding success for Samsung Bioepis, with Justice Meade holding that the Janssen patent is invalid for obviousness in light of a slide presentation entitled “Safety and efficacy of Ustekinumab Induction Therapy in Patients with Moderate to Severe UC: Results from the Phase 3 UNIFI Study” delivered at the October 2018 American College of Gastroenterology conference.

Samsung Bioepis is also currently challenging two of Janssen’s Stelara® (ustekinumab) Australian patents in the Australian Federal Court, with a trial provisionally scheduled for November 2024.

Samsung Bioepis’ ustekinumab biosimilar (SB17) was approved in Europe in April 2024 as Pyzchiva®. Pyzchiva® will be commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

On 1 July 2024, Samsung Bioepis announced that the FDA approved its Pyzchiva® (SB17) for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis.  The FDA has provisionally determined Pyzchiva® as interchangeable with Stelara®.  Samsung Bioepis is licensed to launch Pyzchiva® in the US in Q2 2025, under a settlement and licence agreement with J&J entered in November 2023 resolving US litigation between the companies.