Other Updates

On 6 October 2025, Hikma Pharmaceuticals and Celltrion Inc, announced that they have entered exclusive licensing agreements for 6 biosimilars, across the Middle East and North Africa (MENA) region.  The identities of the biosimilars have not yet been disclosed but they are said to treat “key therapeutic areas”, including allergic diseases, ophthalmology, skeletal-related disorders, immune diseases and oncology.

Under the agreements, Hikma holds the exclusive commercialisation rights across all MENA markets, while Celltrion is responsible for the development, manufacturing and supply of the biosimilars.

Hikma and Celltrion have previously partnered in relation to the commercialisation of multiple biosimilars in MENA, including a January 2023 deal regarding Vegzelma® (CT-P16, biosimilar bevacizumab), 2022 deals for CT-P43 (biosimilar ustekinumab) and Yuflyma™ (biosimilar adalimumab), and agreements for Truxima® (biosimilar rituximab), Remsima®/Remsima® SC (biosimilar infliximab) and Herzuma® (biosimilar trastuzumab).

There have been a number of recent announcements regarding commercialisation of biosimilars in MENA, with deals for Polpharma & MS Pharma in September 2025 (biosimilar guselkumab (PB019), ocrelizumab (PB018) and vedolizumab (PB016)), Bio-Thera & Jamjoom Pharma in September 2025 (biosimilar secukinumab (BAT2306)), and Kashiv & MS Pharma in August 2025 (biosimilar omalizumab (ADL-018)).

On 3 October 2025, Pharmacy Times reported that CSPC Pharmaceutical Group’s SYSA1902 has been shown in a phase 3 study to be clinically equivalent to its reference product, Janssen’s Stelara® (ustekinumab) for the treatment of moderate to severe plaque psoriasis.

The results of the phase 3 study were published in the Journal of the American Academy of Dermatology in April 2025.  The results are likely to form the basis for an FDA approval application.

The phase 3 study follows CSPC’s November 2024 announcement that its biologic license application for ustekinumab was accepted by the People’s Republic of China’s National Medical Products Administration.  CSPC’s ustekinumab biosimilar was developed by related company CSPC Megalith Biopharmaceuticals.

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, with Samsung Bioepis invalidating the patent on the grounds of lack of novelty and lack of inventive step.
• 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 3 October 2025, Celltrion announced that it has launched its intravenous formulation of Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in the United States.  Avtozma® IV is indicated for all reference indications, with the FDA approving an indication extension for the treatment of cytokine release syndrome (CRS) in August 2025.

Avtozma® is the third tocilizumab biosimilar approved in the US (January 2025).  Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) was the first US approved tocilizumab biosimilar (IV formulation, September 2023; launched May 2024), followed by Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024; IV formulation launched April 2024; SC formulation launched July 2024).

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms in November 2023, and Biogen’s IV Tofidence® in June 2024.

Celltrion’s Avtozma® is the first and only tocilizumab biosimilar to be approved in Australia (May 2025) and will be considered for PBS listing at PBAC’s November 2025 meeting.

On 2 October 2025, Formycon announced that it and its licence partners, Klinge Biopharma and Valorum Biologics, have entered a settlement and licence agreement with Regeneron to resolve all US patent disputes relating to FYB203/Ahzantive®, biosimilar to Regeneron’s Eylea® (aflibercept).  Under the terms of the agreement, Valorum may launch Ahzantive® in the US in Q4/2026, or earlier under certain undisclosed circumstances.

FYB203 was approved in the US in June 2024 and had been subject to a preliminary injunction granted by the US District Court for the Northern District of West Virginia in June 2024, resulting from a patent infringement proceeding brought by Regeneron in November 2023.  The injunction was upheld on appeal in January 2025 but has now been vacated as a result of the parties’ settlement.

Sandoz has also recently (in September 2025) settled BPCIA aflibercept litigation with Regeneron, with a US launch date for Sandoz’s Enzeevu® set for Q4/2026 (or earlier under certain undisclosed circumstances).

The only aflibercept biosimilar to have launched in the US to date is Amgen’s Pavblu™, which launched in October 2024 following 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™ (June 2025), which remains pending.

Klinge, Formycon’s exclusive global licensee of FYB203, entered an exclusive licence agreement with Valorum in June 2025 for the commercialisation of FYB203 in the US and Canada.  Under the agreement, Klinge receives royalties on net sales and is eligible to receive upfront and milestone payments, with Formycon receiving a single to low double-digit percentage of those payment streams.  Formycon will additionally receive service payments and a volume-based profit component for organising the commercial market supply on behalf of Klinge.

The dispute between Regeneron/Bayer and Formycon in relation to FYB203 is not limited to the US, with legal proceedings in the US, UK, Italy, Belgium, the Netherlands, and France.  On 25 September 2025, the Munich Regional Court granted Regeneron and Bayer a cross-border preliminary injunction (PI) preventing Formycon from launching FYB203 in a number of European countries, including Germany.  The PI was based on a finding of infringement by equivalence of Regeneron’s formulation patent, EP 2 364 691.

On 1 October 2025, Biocon announced that it has entered into a settlement and licence agreement with Amgen that resolves pending BPCIA patent litigation and permits Biocon’s 1 October 2025 US launch of Bosaya™ and Aukelso™ (denosumab-kyqq), biosimilars to Amgen’s Prolia® and Xgeva® respectively.

Amgen had filed the BPCIA litigation against Biocon on 30 June 2025 in the US District Court for the District of Massachusetts, Eastern Division, asserting infringement of 34 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.

The proceeding against Biocon was one of a number of proceedings that Amgen commenced in the US in relation to denosumab biosimilars, six of which have now settled (including the Biocon settlement):

• A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, with Sandoz launching its denosumab biosimilars, Jubbonti® and Wyost®, in June 2025.
• Fresenius Kabi launched Conexxence® and Bomyntra® in early July 2025, following a global settlement agreement with Amgen, resulting in the dismissal of US BPCIA litigation commenced by Amgen in October 2024.
• Celltrion settled in January 2025, with Celltrion launching Stoboclo® and Osenvelt® in July 2025.
• Accord and Intas settled US litigation with Amgen in July 2025, permitting launch of Accord/Intas’ denosumab biosimilar from 1 October 2025.
• Samsung Bioepis settled in early September 2025, with the terms of that settlement, including launch dates for Samsung Bioepis’ denosumab biosimilars, remaining confidential.

Amgen still has pending US denosumab litigation against Hikma/Gedeon Richter and Shanghai Henlius/Organon, which have had denosumab biosimilar applications accepted for review by the FDA.

Bosaya™ and Aukelso™ received FDA approval in September 2025 and were granted provisional interchangeability designation for all approved indications.  They were the sixth pair of denosumab biosimilars to be approved in the US, following Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), and Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched).  Richter/Hikma’s Enoby™ and Xtrenbo™ (denosumab qbde) were subsequently approved later in September 2025.

On 1 October 2025, the US Patent Trial and Appeal Board (PTAB) issued its decision in the inter partes review (IPR), filed by Amgen in February 2025 and instituted in July 2025, challenging the validity of BMS’ US patent US11332529 (‘529) relating to methods of treating colorectal cancer using nivolumab (Opdivo®) and ipilimumab (Yervoy®).

On 18 August 2025, BMS had filed a statutory disclaimer of all 18 claims of ‘529.  However, in April 2025 it had amended the claims of its pending application US18/787,822 (a continuation of ‘529) to include a new claim 43 that was patentably indistinct from disclaimed claim 1 of the ’529 patent.  BMS sought denial of the ‘529 patent without an adverse judgment.  Amgen successfully argued that an adverse judgment should be issued.

The Board characterised BMS’ actions as employing a “whac-a-mole strategy” and concluded that BMS unfairly sought to avoid Amgen’s challenge through a statutory disclaimer only to pursue patentably indistinct claims in the ’822 continuation application.  It rejected BMS’ attempt to exit “one door of the agency, only to walk back in another door to resurrect the same claims in an ex parte proceeding”.

The Board’s decision notes that BMS had indicated its intention to assert the ’529 patent against Amgen, presumably in relation to Amgen’s nivolumab biosimilar under development.

Xbrane/Intas also has a nivolumab biosimilar under development.  Earlier in 2025, Sandoz suspended the Phase 3 trial of its nivolumab biosimilar.  In April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for an ipilimumab biosimilar.

On 1 October 2025, Sandoz’s Erelzi®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in 50mg/mL syringe and pen devices.

Erelzi® is the third etanercept biosimilar to be PBS-listed (approved November 2017), following Biocon Biologics’ Nepexto® (July 2025 (auto-injector), approved September 2020 (PFS)) and Samsung Bioepis/Arrow Pharma’s Brenzys® (April 2017, approved July 2016).  In August 2025, Biocon’s Nepexto® PFS presentation was recommended for PBS-listing (sponsor: Maxx Pharma).

In May 2022, Pfizer commenced Australian legal proceedings against Samsung Bioepis and other respondents (including MSD, Organon and Arrow Pharmaceuticals) alleging infringement of its Australian patent AU2005280034 relating to the production of etanercept.  Samsung Bioepis and Organon cross-claimed, seeking to invalidate the patent.  The hearing commenced on 1 September 2025 and is scheduled to conclude on 10 October 2025.

Etanercept has been the subject of various lawsuits in the US in recent years.  In May 2025, a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws in relation to Enbrel® (etanercept) (and Otezla® (apremilast)), awarding Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages.

In April 2025, Sandoz announced that it filed an antitrust lawsuit in the US District Court for the Eastern District of Virginia, alleging that Amgen “unlawfully extended and entrenched its monopoly” for Enbrel® by “blocking competition from more cost-effective biosimilar competitors, including Sandoz’s etanercept biosimilar, Erelzi®”.  That litigation is ongoing.

On 29 September 2025, Fresenius Kabi announced that the US Centers for Medicare and Medicaid Services (CMS) assigned a permanent billing code for Conexxence® and Bomyntra®, biosimilars to Regeneron/Bayer’s Prolia® and Xgeva® (denosumab), respectively.  This will provide a streamlined reimbursement procedure for the products, effective 1 October 2025.

Conexxence® and Bomyntra® were FDA approved in March 2025 and launched in the US on 1 July 2025.

Fresenius Kabi entered a global settlement with Amgen in respect of its denosumab biosimilars in March 2025.  The settlement resulted in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen against Fresenius in October 2024.  The global settlement permits European launch of Fresenius’ biosimilars at the end of November 2025.  Conexxence® and Bomyntra® were approved in Europe in July 2025.

On 29 September 2025, Gedeon Richter and Hikma Pharmaceuticals announced they have secured FDA approval for Enoby™ (RGP-14-P) and Xtrenbo™ (RGP-14-P) (denosumab-qbde), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.

Hikma and Richter entered into a licence and commercialisation agreement for RGB-14 in December 2021.  Under the terms of the agreement, Richter is responsible for the development and manufacture of RGB-14, and Hikma is responsible for FDA registration and has exclusive rights to commercialise it in the US.

Richter/Hikma’s denosumab biosimilars are the seventh pair to be approved in the US, following Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched) and Biocon’s Bosaya™ and Aukelso™ (approved September 2025, not yet launched).

On 25 June 2025, Amgen filed BPCIA litigation in the US District Court for the District of New Jersey against Hikma and Richter, asserting infringement of 32 patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.  The litigation followed the FDA’s acceptance in December 2024 of Richter/Hikma’s BLA for RGB-14-P and RGB-14-X.  Although Amgen has settled five of its denosumab BPCIA proceedings against other biosimilar manufacturers, the Richter/Hikma proceedings currently remain pending.