Selarsdi (ustekinumab-aekn) / Alvotech, Fuji Pharma, Cipla, Teva, Stada - LARVOL DELTA

SWITCHING FROM USTEKINUMAB ORIGINATOR TO BIOSIMILAR: NO ADVERSE IMPACT ON INFLAMMATORY BOWEL DISEASE CONTROL AND WELL TOLERATED AT 12 MONTHS IN A UK MULTICENTRE STUDY (UEGW 2026) - "Prior treatment exposure was anti-tumour necrosis factor agents (anti-TNF) in 543 (80%) patients, vedolizumab in 32 (5%) patients and both anti-TNF and vedolizumab in 94 (14%) patients... We observed high treatment persistence rates and stable clinical disease activity and biomarkers with ustekinumab biosimilars one year after switch. Biosimilar ustekinumab was well tolerated and appears to be safe."

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

Ustekinumab originator to biosimilar switch: no adverse impact on inflammatory bowel disease control and well tolerated in a multicentre study (BSG 2026) - "Prior treatment exposure was anti-tumour necrosis factor agents (anti-TNF) in 442 (81%) patients, vedolizumab in 28 (5%) patients and both anti-TNF and vedolizumab in 59 (11%) patients...Biosimilar ustekinumab was well tolerated and appears safe. This cohort will be evaluated again for 12-month outcomes. View this table: View inline View popup Abstract P213 Table 1 Disease activity indices before switch and early after switch"

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

Effective from 1st June 2026 Uzpruvo is recommended as a Best Value Biologic for Ustekinumab on the High Tech Arrangement (Irish Medical Times) - "Reimbursement of ustekinumab on the High tech arrangement for treatment naïve individuals is only supported for BVB medicines, such as Uzpruvo....Uzpruvo is indicated for the treatment of Plaque Psoriasis, Paediatric Plaque Psoriasis, Psoriatic Arthritis and Crohn’s Disease."

Reimbursement • Crohn's disease • Psoriasis • Psoriatic Arthritis

Effectiveness and safety of ustekinumab biosimilar for Inflammatory Bowel Disease in real-world clinical practice: 1-year outcomes. (ECCO-IBD 2026) - "Conclusion In our study, patients with inflammatory bowel disease (IBD) treated with originator ustekinumab (Stelara®) who transitioned to the ustekinumab biosimilar (Uzpruvo®) maintained both clinical and biochemical remission, with a comparable safety and tolerability profile. These findings suggest that the biosimilar is a reliable well-tolerated therapeutic alternative to the reference product, providing an opportunity for substantial cost savings without compromising efficacy or safety."

Clinical • Real-world • Real-world evidence • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

Switching from ustekinumab originator to biosimilar: No adverse impact on inflammatory bowel disease control and well tolerated by patients in a UK multicentre study (ECCO-IBD 2026) - "Prior treatment exposure was anti-tumour necrosis factor agents (anti-TNF) in 440 (81%) patients, vedolizumab in 89 (16%) patients and both anti-TNF and vedolizumab in 65 (12%) patients. Biosimilar ustekinumab was well tolerated and appears to be safe. Biosimilar evaluation will continue with the 12-month review of this cohort."

Clinical • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

Short and medium-term outcomes of ustekinumab biosimilar in patients with Crohn’s Disease (ECCO-IBD 2026) - "No adverse event was observed. Conclusion Administration of the ustekinumab biosimilar appears to be both safe and effective when initiated in UST-naive patients or following switch from originator ustekinumab in CD patients."

Clinical • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

On 18 September 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Usgena, intended for the treatment of adults and children with plaque psoriasis, and adults with psoriatic arthritis, Crohn’s disease and ulcerative colitis. (European Medicines Agency)

CHMP • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Summary of the financial results for the first six months of 2025 (GlobeNewswire) - "Product revenue was $204.7 million for the six months ended June 30, 2025, compared to $65.9 million for the six months ended June 30, 2024, reflecting the sales expansion of AVT02 in the U.S., Canada, and European countries, as well as the increased sales of AVT04 in European countries, and the launch of AVT04 in the U.S."

Sales • Ankylosing Spondylitis • Crohn's disease • Hidradenitis Suppurativa • Idiopathic Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

MedImpact Offers Low Cost, Unbranded Ustekinumab-aekn Biosimilar to Any Specialty Pharmacy in the US (Businesswire) - "The unbranded ustekinumab-aekn biosimilar is expected to be available for purchase on January 01, 2026."

Commercial • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study. (PubMed, BioDrugs) - "The comparative clinical efficacy studies revealed no additional information. This finding adds on to the evidence that clinical PK and the comparative analytical assessment, specifically the comparison of quality attributes with potential immunogenic relevance, suffice for the evaluation of immunogenicity of biosimilars in general."

Journal • Review

Mirikizumab (Omvoh) - an IL-23 antagonist for Crohn's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • IL23A

Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI (ustekinumab-aekn) with Stelara (ustekinumab) (Teva Press Release) - "Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd...and Alvotech...announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara (ustekinumab). As of April 30, 2025, SELARSDI is available and interchangeable in all presentations matching the reference product, including the treatment of adults and pediatric psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis....Approved presentations of SELARSDI are 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection, 45 mg/0.5 mL in a single-dose vial for subcutaneous injection and 130 mg/26 mL in a single-dose vial for intravenous infusion."

FDA approval • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Alvotech Reports Record Results for 2024 and Provides Business Update (GlobeNewswire) - "Product revenue was $273.5 million for the year ended December 31, 2024, compared to $48.7 million for the same period in the prior year. Revenue for the year ended 31 December 2024, consisted of product revenue from sales of AVT02 in select European countries and Canada, launch of AVT02 in the U.S., and the launches of AVT04 in Canada, Japan and select European markets....The license and other revenue of $216.2 million was primarily attributable to the achievement of key research and development milestones during 2024: $6.6 million for the approval of AVT04 in Europe, $16.8 million for the CTA submission for AVT16, a total of $34.4 million for the MAA submissions with the EMA for...AVT05, and AVT06, $39.1 million for the CES completion of...and $56.4 million for the CES completion of AVT05."

Commercial • Sales • Age-related Macular Degeneration • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ophthalmology • Ulcerative Colitis • Wet Age-related Macular Degeneration

Lumicera Secures Purchase Agreement for Stelara Biosimilar, Delivering Major Cost Savings (Businesswire) - "Lumicera Health Services announced today it has secured a purchase agreement with Anda, Inc...for a lower-priced biosimilar version of Stelara (ustekinumab)....Under this agreement, Lumicera's discounted net acquisition cost for the unbranded biosimilar (ustekinumab-aekn) is estimated to generate $120 million in annualized savings for clients....Through this purchase agreement, Lumicera’s health system clients and PBMs can access this product at a significant discount. Navitus will remove Stelara from formulary on July 1, 2025....Lumicera is expected to begin dispensing ustekinumab-aekn July 1, 2025."

Commercial • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

MedImpact Expands Access to Two Biosimilars for Stelara (Businesswire) - "MedImpact Healthcare Systems, the nation’s largest independent provider of health solutions, technology, and pharmacy benefit management services, announced that it is expanding access to two biosimilar alternatives to Stelara (ustekinumab), Selarsdi (ustekinumab-aekn) and Yesintek (ustekinumab-kfce). Consistent with its mission of delivering affordability without compromising access, MedImpact’s approach to biosimilars is pharmacy- and manufacturer-neutral."

Reimbursement • Immunology • Inflammation

Teva and Alvotech Announce SELARSDI (ustekinumab-aekn) Injection Now Available in the U.S. (Teva Press Release) - "Teva Pharmaceuticals...today announced the availability of SELARSDI (ustekinumab-aekn) injection in the U.S., a biosimilar to Stelara (ustekinumab), for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and pediatric psoriatic arthritis...The FDA has provisionally determined that SELARSDI will be interchangeable with the reference biologic Stelara, following the expiration of exclusivity for the first interchangeable biosimilar, on April 30, 2025."

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

Alvotech Reports Financial Results for the First Nine Months of 2024 (GlobeNewswire) - "Research and development (R&D) expenses: R&D expenses were $131.1 million for the nine months ended September 30, 2024, compared to $152.8 million for the same nine months of 2023. The decrease was primarily driven by a one-time charge of $18.5 million relating to the termination of the co-development agreement with Biosana for AVT23 recognized during the nine months of 2023, a decrease of $4.3 million primarily related to programs which have completed clinical phase (i.e., AVT02 and AVT04 programs), a decrease of $6.0 million related to programs for which the clinical phase is substantially completed (i.e. AVT03, AVT05, and AVT06), and overall lower headcount and other R&D expenses of $11.4 million, partially offset by a $17.4 million increase in direct program expenses mainly due to AVT16 that is in clinical phase."

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

Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of SELARSDI (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara (ustekinumab) (GlobeNewswire) - "Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd...announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) in a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion. This approval paves the way for SELARSDI to further align its label with the indications of the reference product Stelara (ustekinumab) in the U.S. at launch, which is expected in the first quarter of 2025."

FDA approval • Launch US • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology

STADA and Alvotech launch Uzpruvo, the first approved ustekinumab biosimilar to Stelara, across Europe (GlobeNewswire) - "STADA and Alvotech have launched Uzpruvo, the first approved biosimilar to Stelara in Europe, across a majority of European countries. This includes the largest markets in the region, where pricing and reimbursement approvals have been secured for market entry. The pioneering launch comes immediately upon expiry of exclusivity rights linked to the European reference molecule patent, offering patients, physicians and payers expanded access at the earliest possible opportunity to a life-altering medicine used in certain indications within gastroenterology, dermatology and rheumatology."

Launch Europe • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis

Stada Launches First Stelara Biosimilar, Uzpruvo, in Germany (NAVLIN DAILY) - "Stada has launched Uzpruvo, the first biosimilar of Johnson & Johnson's Stelara (ustekinumab), in Germany. Uzpruvo is priced at EUR 4,608.80 per syringe (45 mg or 90 mg, Lauer Taxe), 21% lower than Stelara. Additionally, trends suggest that the price could further decrease in the coming weeks, following the typical pattern observed with biosimilar launches."

Launch non-US • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriatic Arthritis

AVT04: An Ustekinumab Biosimilar. (PubMed, Clin Drug Investig) - "The tolerability, safety and immunogenicity profiles of AVT04 were similar to those of reference ustekinumab, and switching from reference ustekinumab to AVT04 had no impact on efficacy, safety or immunogenicity. The role of reference ustekinumab in the management of inflammatory diseases is well established and AVT04 provides an effective biosimilar alternative for patients requiring ustekinumab therapy."

Journal • Review • Crohn's disease • Dermatology • Gastroenterology • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Pediatrics • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL23A

Alvotech Announces Record Preliminary Results for Revenues and EBITDA for the Second Quarter of 2024 (GlobeNewswire) - "Alvotech...announced certain preliminary, unaudited key financial information for the second quarter and six months ended June 30, 2024, as follows:...Preliminary product revenues, from global sales of Alvotech’s biosimilars to Humira (adalimumab) and Stelara (ustekinumab), for the second quarter are $51 – $54 million. Preliminary growth in the first half of approximately 180% year-over-year compared to the same period in 2023, with product revenues of $63 - $66 million for the first six months of this year."

Commercial • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Alvotech and Teva Announce U.S. FDA Approval of SELARSDI (ustekinumab-aekn), biosimilar to Stelara (ustekinumab) (Businesswire) - "Alvotech...and Teva Pharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older....The FDA approval of SELARSDI, referred to as AVT04 during development, was based on a totality of evidence, including analytical and clinical data. The clinical development program included data from: 1) Study AVT04-GL-301...2) Study AVT04-GL-101..."

BLA • Psoriasis • Psoriatic Arthritis

Spain's CIPM Recommends Funding for Several Drugs in Latest Meeting (NAVLIN DAILY) - "At its March meeting, CIPM proposed full or partial funding for seven new drugs and two new indications for one drug already authorized for use in another indication. Additionally, the group proposed funding for a biosimilar referencing Stelara (ustekinumab) in four indications. First, the group recommended Eli Lilly’s Omvoh (mirikizumab) for the treatment of moderately to severely active disease...Lastly, the group also proposed financing for Uzpuvo (ustekinumab) a biosimilar referencing Stelara in four indications:...Treatment of moderate to severe active Crohn's disease in adult patients who have had an inadequate response..."

Reimbursement • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis

JAMP Pharma Group announces the commercial launch and product availability for PrJamteki, the first biosimilar of Stelara (ustekinumab) in Canada (Canada Newswire) - "JAMP Pharma Group...announced today the commercial launch and product availablity for Jamteki, a biosimilar of Stelara (ustekinumab)....The currently approved presentations of Jamteki TM are the 45mg/0.5mL pre-filled syringe with passive safety device for subcutaneous injection (PFS-SD) and the 90mg/mL PFS-SD. This is the second JAMP Pharma biosimilar to receive marketing authorization."

Biosimilar launch • Crohn's disease • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology