Pyzchiva (ustekinumab-ttwe) / Samsung, Sandoz - LARVOL DELTA

[Exclusive] Danish Court "Janssen Appeal Dismissed"⋯Samsung Bioepis Wins 'Pyzchiva' Dispute (Seoul Wire) - "Janssen's appeal against the Danish patent infringement of Samsung Bioepis' Stelara biosimilar 'Pyzchiva (ingredient name: ustekinumab, development code name: SB17)' has been dismissed...On the 10th (local time), the 10th Division of the Eastern High Court of Denmark ruled on Janssen Biotech's appeal of the temporary injunction and order on Pyzchiva against Samsung Bioepis NL BV and contract manufacturing organization (CMO) company AGC Biologics A/S (AGC)...The EP 606 patent covers the dosing regimen and clinical results of Stelara, the original product of Pyzchiva, for the treatment of ulcerative colitis (UC). The priority date of this patent is November 20, 2018 and the expiration date is September 24, 2039. Janssen also owns the 'DK 202300038 Utility Model (hereinafter referred to as 038 Utility Model)' which is identical to the EP 606 patent."

Patent • Ulcerative Colitis

Samsung Bioepis projects $580 mil. in EU cost savings as Stelara biosimilar gains ground (Korea Biomedical Review) - "With patent walls down on the blockbuster immunology drug Stelara, Samsung Bioepis is making its move. Backed by a courtroom win in Europe and new budget impact data, the Korean biosimilar maker is projecting more than €526 million ($580 million) in cost savings across Germany, the U.K., and Sweden over three years by switching to its ustekinumab biosimilar, Pyzchiva....In Germany alone, the model shows Pyzchiva could save €440 million—driven by annual per-patient savings topping €5,000 and a 72 percent uptake rate."

HEOR • Immunology

Similarity of efficacy of SB17 to reference ustekinumab for moderate-to-severe psoriasis through 12 weeks in different demographic and comorbidity subgroups (AAD 2025) - P3 | "SB17 had comparable efficacy to UST irrespective of baseline weight, BMI, disease duration, history of PsA, and prior exposure to biologic therapy at week 12."

Clinical • Dermatology • Immunology • Psoriasis

Sandoz reports strong FY 2024 results and Q4 2024 sales (GlobeNewswire) - "Net sales for the fourth quarter were USD 769 million, up 25% in constant currencies. Net sales for the full year were USD 2.9 billion, up 30% in constant currencies. The biosimilars share of total net sales increased from 23% in FY 2023 to 28% in FY 2024. The strong double-digit biosimilars growth reflects the uptake of Hyrimoz in the US through the private- label agreement with...the Sandoz Hyrimoz and unbranded adalimumab-adaz. In addition...the continued strong demand for the first-ever biosimilar...and the launches of Tyruko and Pyzchiva in Europe all contributed to the strong performance."

Sales • Hidradenitis Suppurativa • Immunology • Inflammatory Bowel Disease • Ophthalmology • Rheumatoid Arthritis

Samsung Bioepis Announces US Launch of PYZCHIVA (ustekinumab-ttwe), Biosimilar to Stelara (Businesswire) - "Samsung Bioepis Co., Ltd. today announced that PYZCHIVA (ustekinumab-ttwe), a biosimilar to Stelara (ustekinumab), is now available in the United States. PYZCHIVA has been approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis. Through Samsung Bioepis’ commercialization partner Sandoz, PYZCHIVA is available to patients across US starting today in 45 mg/0.5 mL and 90 mg/mL pre-filled syringes, 130 mg/26 mL intravenous infusion single-dose vial, and 45 mg/0.5 mL subcutaneous vials....In the US, the license period for PYZCHIVA will begin on February 22, 2025, according to the settlement and license agreement between Samsung Bioepis and Janssen Biotech Inc."

Biosimilar launch • Crohn's disease • Immunology • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Sandoz launches biosimilar Pyzchiva (ustekinumab) across Europe, to treat chronic inflammatory diseases (GlobeNewswire) - "Sandoz...announces the launch of Pyzchiva (ustekinumab) across Europe, starting today. Pyzchiva, developed and registered by Samsung Bioepis, is the first ustekinumab biosimilar to launch in Europe with all reference medicine strengths, including the 130mg vial initiation dose for Crohn’s disease."

Biosimilar launch • Crohn's disease • Immunology • Inflammation

Characterization for the Similarity Assessment Between the Proposed Biosimilar SB17 and Ustekinumab Reference Product Using State-of-the-Art Analytical Methods. (PubMed, Drugs R D) - "In summary, the overall analytical characterization and similarity assessment results show that SB17 is comparable to the EU and US ustekinumab RP in terms of structural, physicochemical, biophysical, and biological attributes."

Journal • Inflammation • IL12A

Biosimilar SB17 versus reference ustekinumab in moderate to severe plaque psoriasis after switching: phase 3 study results up to week 52. (PubMed, J Dermatolog Treat) - "The incidence of treatment-emergent adverse events (SB17 + SB17: 16.5%, UST+SB17: 13.9%, UST+UST: 23.8%) and the overall incidence of anti-drug antibodies occurring after transition were comparable between treatment groups (SB17 + SB17: 5.6%, UST+SB17: 5.1%, and UST+UST: 6.7%). SB17 demonstrated clinical biosimilarity to UST after switching from UST, and maintained long-term comparable efficacy and safety with UST up to Week 52."

Clinical • Journal • P3 data • Dermatology • Immunology • Psoriasis

Budget Impact Analysis to Assess Potential Cost Savings From the Introduction of Ustekinumab Biosimilars in Germany, the UK, and Sweden (ISPOR-EU 2024) - "The introduction of ustekinumab biosimilars provides a significant opportunity for payers to reduce budgetary pressures and improve treatment accessibility across the UK, Germany, and Sweden. It should be noted that this analysis did not cover patients with moderate-to-severe ulcerative colitis, as the indication is still under patent protection for the reference medicine."

HEOR • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis • IL12A

Sandoz reports second-quarter sales and half-year 2024 results (GlobeNewswire) - "In recent months, we saw strong uptake of Hyrimoz in the US, received approval for Pyzchiva (ustekinumab) and Wyost/Jubbonti (denosumab) in the US and Europe and secured a settlement agreement in the US with launch dates in the first half of 2025....Total cash and cash equivalents decreased to USD 0.7 billion on June 30, 2024, compared to USD 1.1 billion on December 31, 2023. Net cash flows from operating activities were more than offset by our first dividend payment of USD 215 million and the Cimerli acquisition of USD 188 million."

Biosimilar launch • Commercial • Age-related Macular Degeneration • Crohn's disease • Immunology • Inflammatory Bowel Disease • Macular Degeneration • Ophthalmology • Osteoporosis • Psoriasis • Ulcerative Colitis • Wet Age-related Macular Degeneration

‘Totality-of-the-evidence’ of proposed ustekinumab biosimilar SB17’ (BSG 2024) - "In a phase III study of patients with moderate-to-severe PsO (Feldman, et al., EADV 2023. P0720), SB17 had equivalent efficacy, comparable safety and immunogenicity to UST-RP up to Week 28.Conclusion With similar target binding and PK and confirmed similarity in efficacy and safety for PsO patients, SB17 is proposed to be highly similar to UST-RP in physicochemical, non-clinical, and clinical studies and data supports its extrapolation to UST-RP indications."

Dermatology • Immunology • Psoriasis • IL12A

FDA approves biosimilar Pyzchiva (ustekinumab-ttwe), to be commercialized by Sandoz in US (GlobeNewswire) - "Sandoz...today announced that the US Food and Drug Administration (FDA) has approved biosimilar Pyzchiva (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion....Sandoz intends to launch Pyzchiva in the US in February 2025, in accordance with the settlement and license agreement with Janssen Biotech Inc....Pyzchiva is approved by the FDA for all indications of the reference medicine Stelara...The FDA granted approval to Samsung Bioepis based on the totality of the evidence, including robust clinical studies confirming that Pyzchiva has equivalent efficacy and comparable safety as its reference medicine."

Biosimilar launch • FDA approval • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Samsung Bioepis to launch Stelara biosimilar 40% cheaper than original (Korea Biomedical Review) - "Samsung Bioepis announced its plans to launch Epyztek (ingredient: ustekinumab), a biosimilar product referencing Janssen's Stelara, in July. Epyztek will be priced 40 percent cheaper than the original...According to the Health Insurance Review and Assessment Service's notice on Wednesday, Epyztek's price will be at 1,298,290 won ($936) for a 45mg/0.5ml pre-filled syringe from July, which is approximately 40 percent less than the original drug (2,182,000 won)....With the launch of Epyztek, Samsung Bioepis now offers a total of nine biosimilar products in Korea, with five being sold directly by the company."

Biosimilar launch • Reimbursement • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

"Totality -of-the-Evidence" of Proposed Ustekinumab Biosimilar SB17 (IMKASID 2024) - "Results : In the analytical assessment, SB17 showed similarity to EU- and US-UST-RP in overall critical and non-critical quality attributes. 3 In a phase I study, SB17 and EU- and US-UST-RP had similar PK and comparable safety, tolerability, and immunogenicity.4 In a phase III study of patients with moderate-to-severe PsO, SB17 had equivalent efficacy, comparable safety and immunogenicity to UST-RP up to Week 28 (Table 1).5 Conclusion : With similar target binding and PK and confirmed similarity in efficacy and safety for PsO patients, SB17 is proposed to be highly similar to UST-RP in physicochemical, non-clinical, and clinical studies and data supports its extrapolation to UST-RP indications."

Dermatology • Immunology • Psoriasis • IL12A

A Randomized, Double-blind, Phase III Study Assessing Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Subjects with Moderate to Severe Plaque Psoriasis. (PubMed, J Am Acad Dermatol) - "SB17 was clinically biosimilar to UST up to Week 28."

Clinical • Journal • P3 data • Dermatology • Immunology • Psoriasis

Sandoz confirms European Commission approval of Pyzchiva (ustekinumab), further strengthening immunology offering (Sandoz Press Release) - "Sandoz...announces that the European Commission (EC) has granted marketing authorization for Pyzchiva (biosimilar ustekinumab), developed and registered by Samsung Bioepis. Pyzchiva is a key biosimilar value driver for the company over the mid-term and this approval is a major step in advancing Sandoz growth strategy....The comprehensive regulatory submission package included extensive analytical, preclinical, and clinical data, including a Phase I PK/PD study and a Phase III confirmatory study."

European regulatory • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Ulcerative Colitis

Samsung Bioepis secures 1st approval in Korea for Stelara biosimilar (Korea Biomedical Review) - "Samsung Bioepis has achieved a significant milestone by obtaining the first domestic approval for a biosimilar referencing Janssen's Stelara, Epyztek (ingredient: ustekinumab), on Thursday....The approval of Epyztek allows Samsung Bioepis to expand its portfolio to include an interleukin inhibitor, further enhancing its offerings for autoimmune disease treatments."

Non-US regulatory • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

Characterization for the similarity assessment between proposed biosimilar SB17 and ustekinumab reference product using state-of-the-art analytical method (ECCO-IBD 2024) - "Based on these results, SB17 is expected to have highly similar safety and efficacy as compared to ustekinumab RP. Conclusion In summary, the overall analytical characterization and similarity assessment results show that SB17 is highly similar to the EU and US ustekinumab RP in terms of structural, physicochemical, biophysical, biological attributes."

Inflammation • Inflammatory Bowel Disease • IL12A

"Totality-of-the-evidence" of proposed ustekinumab biosimilar SB17" (ECCO-IBD 2024) - "5 Conclusion With similar target binding and PK and confirmed similarity in efficacy and safety for PsO patients, SB17 is proposed to be highly similar to UST-RP in physicochemical, non-clinical, and clinical similarity studies. "Totality-of-the-evidence" data for SB17 supports its extrapolation to UST-RP indications."

Inflammatory Bowel Disease • IL12A • IL23A

Samsung Bioepis announces follow-up study results for Stelara biosimilar SB17 in Europe [Google translation] (MedigateNews) - "Samsung Bioepis presented two abstracts of clinical trial follow-up research results for SB17...at the European Crohn's and Colitis Society (ECCO) annual conference held in Stockholm, Sweden from the 21st to the 24th. It was announced on the 22nd that it was announced...The first abstract released by Samsung Bioepis at the academic conference analyzed the structural, physicochemical, biophysical, and biological properties between SB17 and the original drug, and the research results confirmed equivalence in all aspects....The second abstract confirms the comprehensive evidence based on the physicochemical, non-clinical, and clinical equivalence of SB17 and the original drug, and the results of the study are extrapolated to the remaining indications possessed by the original drug in addition to plaque psoriasis for which the SB17 clinical trial was conducted..."

Clinical data • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024 (European Medicines Agency) - "The committee recommended granting a marketing authorisation for Pyzchiva (ustekinumab), a biosimilar medicine intended for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease, a disease causing inflammation of the gut....Nintedanib Accord (nintedanib) for the treatment of adults with idiopathic pulmonary fibrosis, other chronic fibrosing interstitial lung diseases with a progressive phenotype, and systemic sclerosis associated interstitial lung disease."

European regulatory • Crohn's disease • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammatory Bowel Disease • Interstitial Lung Disease • Psoriasis • Systemic Sclerosis • Ulcerative Colitis

Comparison of SB17 and reference ustekinumab in healthy adults: A randomized, double-blind, single-dose, phase I study. (PubMed, Int J Clin Pharmacol Ther) - "This study demonstrated bioequivalence of SB17, EU-UST, and US-UST in terms of PK. Safety, tolerability, and immunogenicity were also comparable between all groups."

Clinical • Journal • P1 data

Samsung Bioepis Secures US License Date for SB17, a Proposed Biosimilar to Stelara (GlobeNewswire) - "Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Johnson & Johnson settling all pending US patent litigation between the two companies and clearing the way for commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of reference medicine Stelara^® (ustekinumab) in the United States (US). In the US, the license period will begin on February 22, 2025. The other terms of the agreement are confidential....'We welcome this agreement which clears the way for SB17 in the US, which has a potential to broaden access to treatment for patients suffering inflammatory conditions.'"

Corporate lawsuit • Licensing / partnership • Immunology • Inflammation

Samsung Bioepis Presents Two Abstracts at EADV 2023 Congress, Highlighting Continuous Dedication in Dermatology (GlobeNewswire) - P3 | N=503 | NCT04967508 | Sponsor: Samsung Bioepis Co., Ltd. | "Samsung Bioepis Co., Ltd.’s new data on its ustekinumab biosimilar candidate SB17 and four-year follow-up data for its adalimumab biosimilar SB5 are presented today at the European Academy of Dermatology and Venereology (EADV) Congress being held from October 11 to 14 in Berlin, Germany....The study met the primary endpoint - percent change from baseline in Psoriasis Area Severity Index (PASI) at Week 12, with an adjusted difference of -0.6 (95% confidence interval (CI): [−3.780 to 2.579], per-protocol set), being fully contained within the pre-defined equivalence margin. Other efficacy and safety endpoints were comparable up to Week 28."

P3 data • Dermatology • Immunology • Psoriasis

A Randomised, Double-blind, Phase III Study Demonstrating Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis (EADV 2023) - P3 | "This study demonstrated biosimilarity of SB17 to UST through equivalent efficacy and comparable safety and PK up to Week 28. Reference: 1. HS Jeong et al."

Clinical • P3 data • Dermatology • Immunology • Psoriasis