Other Updates

On 27 September 2024, Sanofi and Regeneron announced that Dupixent® (dupilumab) has been approved in the US as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.  On the same date, the companies announced that China’s National Medical Products Administration (NMPA) has approved Dupixent® for the same indication.

This follows the UK approval of Dupixent® as an add-on maintenance treatment for COPD earlier this month.

In July 2024, Dupixent® received European approval as an add-on maintenance treatment for adults with uncontrolled COPD, the first approval of Dupixent® for COPD anywhere in the world.  In the same month, Sanofi reported that Q2 2024 Dupixent® sales grew by 29.2% to over €3.3B.

On 27 September 2024, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Ixifi™, biosimilar to Janssen’s Remicade® (infliximab), in 100mg powder for injection vial for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease, refractory fistulising Crohn’s disease and ulcerative colitis.

This is the second approval for a Pfizer-sponsored infliximab biosimilar, with Inflectra® having been the first infliximab biosimilar approved in Australia in November 2015.

On 26 September 2024, the TGA provisionally approved Janssen’s Talvey® (talquetamab) in 2mg/ml and 40mg/ml solutions for injection vial for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least four prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.  Talvey® was granted accelerated approval in the US by the FDA in August 2023.

Also on 26 September 2024, Celltrion’s Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), received Australian approval for a lower dose of 20mg/0.2ml solution for injection pre-filled syringe.  Yuflyma® has previously been approved in Australia in 40mg/0.4ml (March 2022) and 80mg/0.8ml (30 June 2023) forms and was PBS listed in March 2023 (40mg/0.4ml).

On 27 September 2024, Formycon and Fresenius Kabi announced that Otulfi®/FYB202, biosimilar to Janssen’s Stelara® (ustekinumab), has received approval from both the European Commission and the US FDA.  The European approval is for moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis, while the US approval is for the same indications with the addition of ulcerative colitis.

Otulfi®/FYB202 is being commercialised in the US and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023.  Under the agreement, Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.

In March 2024 Formycon and Fresenius announced they reached a settlement with J&J/Janssen regarding the commercialisation of FYB202 in Europe and Canada.  This followed a US settlement in August 2023, enabling US launch of FYB202 “no later than 15 April 2024”.

Ustekinumab biosimilars previously approved in Europe are Samsung Bioepis’ Eksunbi™ (September 2024), Celltrion’s SteQeyma®/CT-P47 (August 2024), Amgen’s Wezenla™ (June 2024), Sandoz/Samsung Bioepis’ Pyzchiva®/SB17 (April 2024, launched July 2024), and Alvotech/Stada’s Uzpruvo® (January 2024, launched July 2024).  Bio-Thera’s MAA for BAT2206 (ustekinumab) was accepted by the EMA in July 2024.

In the US, approved ustekinumab biosimilars are Samsung Bioepis’ Pyzchiva®/SB17 (July 2024), Alvotech/Teva’s Selarsdi™ (April 2024) and Amgen’s Wezlana® (October 2023).  Further approvals and are anticipated in light of J&J/Janssen’s ustekinumab settlements with Biocon (BLA for Bmab 1200 accepted May 2024, US launch dated no later than 22 February 2025), Accord BioPharma (BLA for DMB-3115 accepted January 2024, US launch date no later than 15 May 2025) and Celltrion (application submitted with the FDA for CT-P43 in June 2023, US launch date of 7 March 2025).

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 25 September 2024, Eli Lilly published three-year data for its atopic dermatitis treatment, Ebglyss™ (lebrikizumab-lbkz).  The results, presented at the European Academy of Dermatology and Venereology (EADV), reportedly show that more than 80% of adults and adolescents with moderate-to-severe atopic dermatitis who responded to Ebglyss™ at week 16 and continued treatment for up to three years experienced sustained skin clearance with monthly maintenance dosing.  The results are also reported to show that nearly 87% of patients did not require high-potency topical corticosteroids or systemic treatments during the study period.

Earlier this month, the US FDA approved Ebglyss™ for adults and children 12 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies.

On 25 September 2024, MSD announced that Japan’s Ministry of Health, Labour and Welfare approved its Keytruda® (pembrolizumab) in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy, for patients with non-small cell lung carcinoma (NSCLC).  This NSCLC indication approval is based on results from the Phase 3 KEYNOTE-671 trial and follows approvals for the same indication in the EU (March 2024) and US (October 2023).

On the same date, MSD announced that Keytruda® has also been approved in Japan as monotherapy for patients with radically unresectable urothelial carcinoma who are not eligible for any platinum-containing chemotherapy and, in combination with Astellas’ Padcev® (enfortumab verdotin-ejfv), for first-line treatment of radically unresectable urothelial carcinoma.  These approvals were based on results of the Phase 2 KEYNOTE-052 and Phase 3 KEYNOTE-A39 trials, respectively.

The Padcev®/Keytruda® combination was approved in Europe earlier this month as first-line treatment for unresectable or metastatic urothelial cancer and in the US in December 2023 for the same indication.  Padcev®, an antibody drug conjugate, is co-developed by Astellas and Pfizer under a global development and commercialisation collaboration.

On 25 September 2024, Biocon Biologics Ltd announced new data on its adalimumab and ustekinumab biosimilars, presented at the 2024 European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam.

The first set of data is results from a Phase 3 study comparing the efficacy, safety, immunogenicity, and pharmacokinetics of Biocon’s Bmab 1200 (bUstekinumab), with Janssen’s Stelara® (ustekinumab) in adult patients with moderate to severe chronic plaque psoriasis.  The results are said to show biosimilarity between Bmab 1200 and Stelara®.

In May 2024, Biocon announced that the FDA accepted its BLA for Bmab 1200 for review under the 351(k) pathway.  In February 2024, Biocon entered a settlement agreement with Janssen enabling it to launch Bmab 1200 in the US in February 2025.  A second patent settlement and licence agreement was entered between Biocon and Janssen in August 2024, allowing Biocon to commercialise Bmab 1200 in Europe, the UK, Canada and Japan.  Biocon has submitted regulatory applications in each of these jurisdictions.

The second set of data is results from a Phase 3 study evaluating repeated switches between Biocon’s Hulio® (adalimumab-fkhp, 40mg/0.8ml) and AbbVie’s high-concentration Humira® (adalimumab, 40mg/0.4ml) in patients with moderate to severe chronic plaque psoriasis.  This data reportedly shows interchangeability between the two products.  Biocon says it has submitted the data to the FDA to support an interchangeable designation for its adalimumab biosimilar.

Biocon’s Hulio® (adalimumab-fkhp) was first approved in Europe in 2018 and in the US in 2020.

On 25 September 2024, Alvotech announced commencement of a Phase 3 clinical trial for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), in moderate to severe ulcerative colitis.

In August 2024, Intas Pharmaceutical received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase 3 clinical study of its vedolizumab biosimilar, INTP53.  In February 2024, Polpharma Biologics announced that its PB016 (vedolizumab) demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®.

Takeda obtained FDA approval of Entyvio® (vedolizumab) for ulcerative colitis in September 2023, and more recently (in April 2024) has received FDA approval for subcutaneous administration of Entyvio®.

On 23 September 2024, Celltrion announced that it presented the 52-week results of its Phase 3 trial of Eydenzelt™ (CT-P42), biosimilar to Regeneron’s Eylea® (aflibercept), at the European Society of Retina Specialists (EURETINA) conference held from 19-22 September in Barcelona.

Celltrion reports that the Phase 3 trial showed that Eydenzelt™ has comparable efficacy and safety to Eylea® over 52 weeks in patients with diabetic macula oedema (DME).

Eydenzelt™ was approved in Korea in May 2024.  Celltrion sought EU marketing authorisation for CT-P42 in November 2023 and filed an NDA with the FDA in June 2023.

In November 2023 and May 2024, Regeneron commenced US BPCIA proceedings against Celltrion in the US District Court (Northern District of West Virginia), alleging infringement of 38 and 25 patents respectively relating to aflibercept.  These proceedings are ongoing.

On 23 September 2024, the United States District Court for the Northern District of West Virginia denied Regeneron’s motion for a preliminary injunction against Amgen seeking to prevent it from launching Pavblu™, biosimilar to Regeneron’s Eylea® (aflibercept), in the US.  The order is currently under seal.

On the same date, Regeneron filed an appeal from the preliminary injunction determination.

The proceeding against Amgen is part of consolidated, multi-district BPCIA litigation brought by Regeneron regarding aflibercept biosimilars against each of Amgen (aBLA for ABP 938/Pavblu™ accepted by FDA in October 2023 and approved in August 2024), Samsung Bioepis (2 actions; Opuviz™/SB15 approved May 2024), Biocon (Yesafili™ approved May 2024), Formycon (Ahzantive®/FYB203 approved June 2024), Celltrion (2 actions, aBLA for CT-P42 submitted to FDA in June 2023) and Sandoz (Enzeevu™ approved August 2024).

The Court’s refusal to grant a preliminary injunction against Amgen differs from decisions of the same Court to grant preliminary injunctions against Samsung Bioepis (14 June 2024), Formycon (21 June 2024) and Celltrion (June-July 2024), and a permanent injunction against Biocon (11 June 2024), based on findings of infringement of Regeneron’s US patent 11,084,865 (ophthalmic formulations of a VEGF antagonist).

Samsung Bioepis, Formycon and Celltrion lodged appeals from the preliminary injunction orders (on 14 June 2024, 25 June 2024, and 10 July 2024, respectively).  Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024.  Those appeals are all pending.