AVT05 (golimumab biosimilar) / Alvotech, Lupin, Teva, Fuji Pharma - LARVOL DELTA

Pharmacokinetic Similarity of Biosimiliar AVT05 Versus Reference Product Golimumab in Healthy Adults: A Double-Blind, Three-Arm, Parallel-Group Study. (PubMed, BioDrugs) - P1 | "Following single-dose administration, the study supported a demonstration of PK similarity between AVT05 and EU-RP and US-RP in healthy participants. Safety, tolerability, and immunogenicity profiles were comparable between the treatment arms."

Journal • PK/PD data

Efficacy and Safety of Biosimilar AVT05 Versus Reference Product Golimumab in Combination with Methotrexate in Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results of a Randomized, Parallel-Group, Double-Blind Study. (PubMed, BioDrugs) - P3 | "Analysis of the change in DAS28-CRP from baseline to Week 16 supported the assessment of comparative efficacy between AVT05 and RP golimumab. Secondary efficacy endpoints were consistent with this, including in participants who switched. AVT05 had a safety and immunogenicity profile similar to that observed for RP at all timepoints, including in participants who switched treatments."

Clinical • Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Alvotech…announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05… (GlobeNewswire) - "The CRL noted that certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility that concluded in July 2025, must be satisfactorily resolved before this BLA for AVT05 can be approved. The FDA did not identify any other deficiencies with the application."

CRL • Ankylosing Spondylitis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Alvotech Announces Marketing Approval in Japan of Three New Biosimilars (GlobeNewswire) - "The biosimilars approved for the Japanese market are AVT03, a biosimilar to Ranmark (denosumab), AVT05, a biosimilar to Simponi (golimumab) and AVT06, a biosimilar to Eylea (aflibercept). Based on publicly available information, AVT05 is the first golimumab biosimilar to be approved for sale in major markets globally."

Japan approval • Age-related Macular Degeneration • Osteoporosis • Retinal Vein Occlusion • Rheumatoid Arthritis

A pharmacokinetic (PK) similarity study between AVT05 and reference product golimumab (BSG 2025) - "The primary PK parameters (AUC0-inf and Cmax) were slightly lower in ADA positive participants compared to ADA negative ones.Download figure Open in new tab Download powerpoint Abstract P266 Figure 1 Study schematic for AVT05-GL-P01Conclusions Following a single dose administration, the study supported a demonstration of pharmacokinetic similarity between AVT05 and EU-and US-RP in healthy participants. Safety, tolerability, and immunogenicity profiles were comparable between the treatment arms."

PK/PD data

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

Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi and Simponi Aria (golimumab) (GlobeNewswire) - "Alvotech...and Teva Pharmaceuticals...today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, Alvotech’s proposed biosimilar to Simponi and Simponi Aria (golimumab), which are prescribed to treat a variety of inflammatory conditions. These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. The FDA review process for these applications is anticipated to be completed in the fourth quarter of 2025."

FDA approval • FDA filing • Ankylosing Spondylitis • Psoriatic Arthritis • Rheumatoid Arthritis

Assessment of Comparative Efficacy Between Candidate Biosimilar AVT05 and Reference Golimumab (ACR Convergence 2024) - P3 | "Analysis of the change in DAS28-CRP from baseline to Week 16 supports the assessment of comparative efficacy between AVT05 and RP. AVT05 had a safety and immunogenicity profile similar to that observed for RP up to Week 16, persisting to Week 24."

Clinical • CRP

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

European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi (golimumab) (GlobeNewswire) - "Alvotech...announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi (golimumab), a biologic used to treat several chronic inflammatory diseases. This is believed to be the first marketing authorization application filing announced globally for a biosimilar candidate to Simponi. The approvals process is anticipated to be completed in the fourth quarter of 2025."

EMA filing • Immunology • Rheumatoid Arthritis

Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX (clinicaltrials.gov) - P3 | N=502 | Completed | Sponsor: Alvotech Swiss AG | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A PHARMACOKINETIC (PK) SIMILARITY STUDY BETWEEN AVT05 AND REFERENCE PRODUCT GOLIMUMAB (EULAR 2024) - "Following a single dose administration, the study supported a demonstration of pharmacokinetic similarity between AVT05 and EU-and US-RP in healthy participants. Safety, tolerability, and immunogenicity profiles were comparable between the treatment arms."

PK/PD data • Immunology • Rheumatoid Arthritis • Rheumatology

Alvotech Reports Financial Results for First Quarter of 2024 and Provides a Business Update (GlobeNewswire) - "Product revenue was $12.4 million for the three months ended March 31, 2024, compared to $15.7 million for the same three months of 2023. Revenue for the three months ended March 31, 2024, consisted of product revenue from sales of AVT02 in select European countries and Canada, launch of AVT02 in the U.S and launch of AVT04 in Canada....R&D expenses were $49.9 million for the three months ended March 31, 2024, compared to $50.9 million for the same three months of 2023. The slight 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 three months of 2023, and a $17.8 million increase in direct program expenses mainly from five biosimilar candidates, AVT03, AVT05, AVT06, AVT16 and AVT23 that are in clinical phase."

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

Alvotech Announces Topline Results from a Confirmatory Clinical Study for AVT05, a Proposed Biosimilar for Simponi (golimumab) (GlobeNewswire) - P3 | N=502 | NCT05842213 | Sponsor: Alvotech Swiss AG | "Alvotech...announced today positive topline results from a confirmatory clinical study for AVT05, Alvotech’s proposed biosimilar to Simponi and Simponi Aria (golimumab)....The study met its primary endpoint, with results demonstrating therapeutic equivalence between AVT05 and Simponi. Additionally, no clinically meaningful differences in safety were observed through week 24."

P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Alvotech Reports Financial Results for Full Year 2023 and Provides a Business Update (GlobeNewswire) - "Cost of product revenue: Cost of product revenue was $160.9 million for the year ended December 31, 2023, as a result of the successful launch of AVT02 in select European countries, Canada and Australia....Research and Development (R&D) Expenses: R&D expenses were $210.8 million for the year ended December 31, 2023, compared to $180.6 million for the same period in the prior year. The increase was primarily driven by a charge of $18.5 million relating to the termination of the co-development agreement with Biosana for AVT23, and a $42.5 million increase in direct program expenses mainly from three biosimilar candidates, AVT03, AVT05 and AVT06, that entered clinical development in 2022."

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

Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi and Simponi Aria (GlobeNewswire) - P1 | N=336 | NCT05632211 | Sponsor: Alvotech Swiss AG | "Alvotech...announced today positive top-line results from a pharmacokinetic study for AVT05...The study, which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi in healthy adult subjects, met its primary endpoints."

P1 data • Immunology • Rheumatoid Arthritis

A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=336 | Completed | Sponsor: Alvotech Swiss AG | Active, not recruiting ➔ Completed

Trial completion

Alvotech Reports Financial Results for First Six Months of 2023 and Provides Business Update (GlobeNewswire) - "Cost of product revenue: Cost of product revenue was $67.9 million for the six months ended June 30, 2023, as a result of the successful launch of AVT02 in select European countries and Canada....R&D expenses were $99.6 million for the six months ended June 30, 2023, compared to $86.9 million for the same six months of 2022. The increase 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, and a $24.6 million increase in direct program expenses mainly from three biosimilar candidates, AVT03, AVT05 and AVT06, that entered clinical development in 2022."

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

Comparative, Multicenter Study in Subjects With Rheumatoid Arthritis, ALVOFLEX (clinicaltrials.gov) - P3 | N=502 | Active, not recruiting | Sponsor: Alvotech Swiss AG | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=336 | Active, not recruiting | Sponsor: Alvotech Swiss AG | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2023 ➔ Oct 2023 | Trial primary completion date: Jun 2023 ➔ Oct 2023

Enrollment closed • Trial completion date • Trial primary completion date

Alvotech And Advanz Pharma Extend Partnership To Commercialize Five Proposed Biosimilars In Europe (Market Screener) - "Advanz Pharma...and Alvotech announced that they entered an exclusive partnership agreement regarding supply and commercialization of five biosimilars in Europe, with Alvotech responsible for the development and commercial supply of the biosimilars, and Advanz responsible for registration and commercialization in Europe. Per the announcement, the agreement includes proposed biosimilars to SIMPONI® (golimumab) and ENTYVIO® (vedolizumab) and three undisclosed, early stage biosimilar candidates. According to IQVIA, the current market for these five biosimilars covered by the agreement, within the markets covered by the agreement, exceeds $4 billion."

Licensing / partnership • Immunology

Alvotech Reports Financial Results for First three Months of 2023 and Provides Business Update (GlobeNewswire) - "R&D expenses were $50.9 million for the three months ended March 31, 2023, compared to $47.1 million for the same three months of 2022...and a $10.5 million increase in direct program expenses mainly from three biosimilar candidates, AVT03 and AVT06, that entered clinical development in 2022 and AVT05 that entered clinical development in 2023. These increases were partially offset by a decrease in spending of $13.8 million primarily related to programs for which the clinical activities were winding down. In addition, there was a reclassification of pre-commercial manufacturing activities of $12.4 million, that were previously recognized as R&D expense, which are now being recognized as cost of product revenue, in conjunction with the Company’s commercial launch of AVT02."

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

"$ALVO Alvotech Initiates Confirmatory Patient Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria® #stocks https://t.co/UzXdM0TqKG" (@stock_titan)

Clinical

Comparative, Multicenter Study in Subjects With Rheumatoid Arthritis, ALVOFLEX (clinicaltrials.gov) - P3 | N=472 | Recruiting | Sponsor: Alvotech Swiss AG

New P3 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=336 | Recruiting | Sponsor: Alvotech Swiss AG | Not yet recruiting ➔ Recruiting

Enrollment open