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

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

Alvotech Announces Expected Global Market Entry Dates for AVT04 Biosimilar to Stelara (ustekinumab) (GlobeNewswire) - "Alvotech...announced that it has reached settlement agreements with Johnson & Johnson in Japan, Canada and in the European Economic Area (EEA) for AVT04, a biosimilar to Stelara (ustekinumab). Regulatory approval for AVT04 in these markets has already been granted. Market applications for AVT04 are currently pending in additional global markets, including in the U.S...Market entry of AVT04 in Canada is expected in Q1 2024. Launch of AVT04 in Japan is anticipated after the upcoming round of National Health Insurance reimbursement price listings, in May 2024. Entry to the first European markets is expected as soon as possible after the expiration date of the European Supplementary Protection Certificate (SPC) for Stelara, which is in late July 2024...Alvotech and Teva....grants an entry date for AVT04 in the U.S. no later than February 21, 2025..."

Biosimilar launch • Licensing / partnership • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Rheumatology

Alvotech Provides Update on Status of Biologics License Applications for AVT02 and AVT04 (Yahoo Finance) - "Alvotech...announced that the reinspection of Alvotech’s facility in Iceland by the U.S. Food and Drug Administration (FDA) which started on January 10, 2024, has been concluded. Following the FDA inspection, Alvotech received a form 483 with one observation. Alvotech expects to provide the FDA with a response in the following days....Based on the conclusion of the facility reinspection, Alvotech believes it is in a position to receive approval in the U.S. for AVT02 and AVT04 by February 24, 2024, and April 16, 2024, their respective goal dates."

BsUFA date • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

STADA and Alvotech secure approval for Uzpruvo, Europe’s first ustekinumab biosimilar to Stelara (Alvotech Press Release) - "Partners STADA and Alvotech today announced that the European Commission issued a marketing authorization for Uzpruvo^® (AVT04), a biosimilar candidate to Stelara^® (ustekinumab). The centralized marketing authorization for Europe’s first ustekinumab biosimilar is valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway. This European marketing authorization for Uzpruvo paves the way for market entry as soon as possible, following the expiry in July 2024 of a European Supplementary Protection Certificate (SPC) for Stelara."

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

STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara (GlobeNewswire) - "Partners STADA and Alvotech today announced that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency’s (EMA) has adopted a positive opinion for Uzpruvo (AVT04), a biosimilar candidate to Stelara (ustekinumab). The positive CHMP opinion for Uzpruvo marks the first time that the EMA has proposed authorizing a biosimilar to the Stelara reference product. A marketing authorization with the indications Crohn’s disease, psoriasis and psoriatic arthritis would be valid across all European Union (EU) member states, as well as in Iceland, Liechtenstein and Norway."

European regulatory • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis

Alvotech Reports Financial Results for First Nine Months of 2023 and Provides Business Update (GlobeNewswire) - "License and other revenue was $8.2 million for the nine months ended September 30, 2023, compared to $48.1 million for the same nine months of 2022. The decrease of $39.9 million was primarily attributable to the recognition of a $34.7 million research and development milestone during the same period in the prior year, due to the completion of the AVT04 main clinical program....R&D expenses were $152.8 million for the nine months ended September 30, 2023, compared to $133.1 million for the same nine months of 2022....These increases were partially offset by a decrease of $28.3 million primarily related to programs that have completed clinical phase (i.e., AVT02 and AVT04)."

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

Alvotech and JAMP Pharma Announce Receipt of Marketing Authorization for Jamteki (AVT04), the First Biosimilar of Stelara (ustekinumab) (GlobeNewswire) - "Alvotech...and JAMP Pharma Group...announced today that Health Canada has granted JAMP Pharma marketing authorization for AVT04, a biosimilar to Stelara (ustekinumab) developed by Alvotech. AVT04 will be marketed under the brand name Jamteki. The currently approved presentations of Jamteki are a 45mg/0.5mL pre-filled syringe with passive safety device for subcutaneous injection (PFS-SD) and the 90mg/mL PFS-SD."

Canadian regulatory • Crohn's disease • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology

Alvotech Provides Update on Status of U.S. Biologics License Application for AVT04 (GlobeNewswire) - "Alvotech...announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT04, a biosimilar candidate to Stelara® (ustekinumab). As expected, the CRL noted that certain deficiencies, which were conveyed following the FDA’s inspection of the company’s Reykjavik facility that concluded in March 2023, must be satisfactorily resolved before the application can be approved. No other deficiencies in the application were noted by the FDA. Alvotech intends to resubmit the BLA for AVT04 to the FDA shortly, which would likely trigger a six-month review period and a new Biosimilar User Fee Act (BsUFA) goal date."

FDA event • Immunology • Psoriasis

Alvotech Announces Approval in Japan of AVT04 (ustekinumab), a Biosimilar to Stelara (GlobeNewswire) - "Alvotech...today announced that its commercialization partner in Japan, Fuji Pharma Co., Ltd. ('Fuji'), has received marketing approval for AVT04 (ustekinumab), a biosimilar to Stelara®, from the Japanese Ministry of Health, Labor and Welfare."

Japanese regulatory • Immunology • Psoriasis

Biosimilar AVT04 Comparable to Ustekinumab in Treating Chronic Psoriasis (HCPLive) - "'The development of biosimilars is a difficult process due to the complex molecular structure of the reference biologics,' wrote Steven R Feldman, MD, PhD...'Various regulations and guidelines have been put in place for the development and licensing of biosimilar products. Currently, no biosimilar to the reference product has been approved.'"

Media quote

Teva Pharmaceuticals and Alvotech Provide Update on Strategic Biosimilars Partnership (Businesswire) - "Teva Pharmaceuticals, Inc...announced that they have agreed to expand their existing strategic partnership agreement. Teva will also acquire subordinated convertible bonds to be issued by Alvotech. The partners continue working closely on matters concerning pending approval in the U.S. for AVT02, an interchangeable high-concentration biosimilar candidate for Humira® (adalimumab)....The agreement also includes increased involvement by Teva regarding manufacturing and quality at Alvotech’s manufacturing facility. Teva is actively supporting Alvotech on-site in Iceland to be fully ready for an FDA inspection."

Licensing / partnership • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis