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 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.

On 12 July 2023, Samsung Bioepis UK Limited commenced proceedings against Janssen Biotech Inc in the High Court of Justice of England and Wales seeking to invalidate the UK counterpart patent of European Patent No. EP 3 883 606.  Janssen’s patent relates to the use of ustekinumab for the treatment of ulcerative colitis and Janssen counter-claimed against Samsung Bioepis for patent infringement.  Mr Justice Meade heard the case on 24-26 June and 1-2 July 2024.  Judgment is expected within the next few months.  

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. 

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.   

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. 

On 16 May 2024, Biocon reported that the US’s FDA had accepted Biocon’s BLA for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway. Biocon had earlier signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson that allows Biocon to commercialize Bmab 1200, subject to regulatory approval, in the U.S. by no later than 22 February 2025. More recently, industry media has reported that Biocon’s Bmab 1200 is currently in Phase III for the treatment of Crohn’s Disease. 

On 25 April 2024, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for Amgen’s Wezenla™ (ustekinumab), biosimilar to Janssen’s Stelara®.   Wezenla™ is proposed to be available in a 45 mg and 90 mg solution for injection, as well as a 130 mg solution for infusion.

Amgen’s Wezlana™ was approved in the US in October 2023, was launched in Canada in March 2024 and was listed on the Australian PBS in January 2024.

CHMP’s positive recommendation for Wezenla™ comes days after Samsung Bioepis’ Pyzchiva® (ustekinumab) was approved in the EU on 25 April 2024.

On 22 March 2024, the first case management hearing was held before Justice Nicholas in the Federal Court of Australia, Sydney, in proceedings commenced by Samsung Bioepis for revocation of two Janssen patents regarding the use of ustekinumab for the treatment of ulcerative colitis.  Samsung Bioepis informed the Court that it has applied for regulatory approval of its biosimilar referencing Stelara® and is expecting PBS (reimbursement) approval in July/August 2025.   The Court has provisionally scheduled a trial for 18 – 22 November 2024.

On 13 March 2024, Sandoz reported double-digit growth of 15% in its 2023 biosimilar sales.  Sandoz attributed this growth to the launch of Hyrimoz®(biosimilar to AbbVie’s Humira®,adalimumab)  in the US and entering an agreement to commercialise Samsung Bioepis’ SB17 (biosimilar to Janssen Biotech’s Stelara®) in the US, Canada, EEA, Switzerland, and UK.

In March 2024, Sandoz announced completion of its acquisition of Coherus Biosciences’ Cimerli®, biosimilar to Genentech’s Lucentis® (ranibizumab), for US$170M.