Hukyndra (adalimumab biosimilar) / Cipla, Alvotech, Stada, Teva, JAMP Pharma, YAS Holding - LARVOL DELTA

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

MedImpact Expands Access to Two Humira Biosimilars for New Patients (Businesswire) - "MedImpact Healthcare Systems, Inc...announced that it is expanding access to Humira biosimilars, Simlandi and adalimumab-adaz, for new patients requiring medication for inflammatory conditions such as Crohn’s disease or rheumatoid arthritis. Patients already taking Humira through their pharmacy benefit can continue to do so, and new patients who have taken one of the two biosimilars but did not see the desired results may switch to Humira."

Reimbursement • Ankylosing Spondylitis • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

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 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

Teva and Alvotech Announce SIMLANDI (adalimumab-ryvk) Injection Now Available in the U.S. (Businesswire) - "Teva Pharmaceuticals...and Alvotech...announced the availability of SIMLANDI (adalimumab-ryvk) injection in the U.S., as an interchangeable biosimilar to Humira for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis....SIMLANDI is approved by the U.S. Food and Drug Administration (FDA) as the first high-concentration, citrate-free biosimilar to Humira with interchangeability exclusivity for the 40mg/0.4mL injection."

Biosimilar launch • Ankylosing Spondylitis • Crohn's disease • Hidradenitis Suppurativa • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

U.S. Commercialization Agreement with Quallent to Drive Patient Savings with First High-Concentration Citrate-Free Interchangeable Biosimilar to Humira (adalimumab) (GlobeNewswire) - "Alvotech...and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd...disclosed today that under the recently announced U.S. strategic partnership agreement, Alvotech will manufacture its high-concentration interchangeable biosimilar to Humira (adalimumab) for Quallent Pharmaceuticals in alignment with its U.S. commercialization agreement with Teva. The interchangeable biosimilar will be distributed under Quallent’s private label."

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

Alvotech signs U.S. agreement to expand access for newly approved high-concentration interchangeable biosimilar to Humira (adalimumab) (GlobeNewswire) - "Alvotech...announced today a long-term agreement with a strategic partner to further enhance access to Adalimumab-ryvk in the U.S. market, the newly U.S. Food and Drug Administration (FDA) approved high-concentration interchangeable biosimilar to Humira....The current multi-product commercialization partnership between Teva Pharmaceuticals and Alvotech remains unchanged and Teva will continue to commercialize adalimumab-ryvk under the SIMLANDI brand in the U.S."

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

Early Real-World Experience With Abrilada Within the Canadian Patient Population (ISPOR 2024) - "Results were compared to the reference adalimumab (D2E7, “ADL-Ref”) and other adalimumab biosimilars (ABP501, SB5, FKB327, GP2017, MSB11022, AVT02 and CT-P17) This retrospective cohort study utilized longitudinal claims data from IQVIA Canada’s Private Drug Plan and Ontario Drug Benefit databases... Our findings suggest high persistence and adherence rates for patients receiving adalimumab-afzb in a real-world setting. Further studies are needed to determine the persistence and adherence of adalimumab biosimilars over an extended duration."

Clinical • Real-world • Real-world evidence • Anesthesia • Hematological Disorders • Immunology • Pain

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 and Teva Announce U.S. Approval of SIMLANDI (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira (Teva Press Release) - "Alvotech and Teva Pharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) has approved SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis....The FDA approval of SIMLANDI was based on a totality of evidence, including analytical, non-clinical, and clinical data. The clinical development program, included data from (i) AVT02-GL-101...(ii) AVT02-GL-301...and (iii) AVT02-GL-302..."

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

Ex vivo comparative immunogenicity assessment (EVCIA) to determine relative immunogenicity in chronic plaque psoriasis in participants receiving Humira or undergoing repeated switches between Humira and AVT02. (PubMed, Immunother Adv) - "The comparable ex vivo cellular immunogenicity between switching and non-switching arms complements the confirmation of interchangeability in the main study. Given the sensitivity of novel EVCIA, detecting cellular immunogenicity could be a potential outcome in predicting the immunogenicity of biologic medicines."

Journal • Preclinical • Dermatology • Immunology • Psoriasis

The totality of evidence approach in the development of AVT02 (adalimumab), a biosimilar to Humira. (PubMed, Ther Adv Chronic Dis) - "Clinical studies supported similar pharmacokinetic and comparable immunogenicity profiles between AVT02 and the RP in healthy participants and participants with moderate-to-severe chronic plaque psoriasis, with no new safety signals detected. The totality of evidence described demonstrates the biosimilarity of AVT02 to the RP, thereby fulfilling the scientific and regulatory requirements for AVT02 as a high-concentration biosimilar for the treatment of chronic plaque psoriasis and all approved indications of the RP."

Journal • Review • Dermatology • Immunology • Oncology • Psoriasis

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

Sandoz announces agreement to acquire CIMERLI business from Coherus, strengthening position in US market (Sandoz Press Release) - "Sandoz...has signed an agreement to acquire the US biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc. for an upfront cash purchase payment of USD 170 million. This is inclusive of a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software....Closing is anticipated in 1H 2024, subject to standard conditions and approvals."

M&A • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

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

Navigating adalimumab biosimilars: an expert opinion. (PubMed, J Comp Eff Res) - "The patent expiry of Humira in 2018 opened up the current European market to eight adalimumab biosimilars - (in alphabetical order) Amgevita, Amsparity, Hulio, Hukyndra, Hyrimoz, Idacio, Imraldi and Yuflyma - for the treatment of various immune and inflammatory conditions. This article explores the characteristics of various adalimumab biosimilars to help clinicians navigate the various options available across Europe and the USA. In addition to drug selection, effective patient-physician communication is needed to nurture realistic patient expectations and minimise potential nocebo effects when prescribing biosimilars."

Journal • Review

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

Alvotech Provides U.S. Regulatory Update on AVT02, a High-Concentration Interchangeable Biosimilar Candidate to Humira (adalimumab) (BioSpace) - "Alvotech...announced today that the U.S. Food and Drug Administration (FDA) has accepted Alvotech’s resubmitted Biologics License Application (BLA) for AVT02, a high-concentration, interchangeable biosimilar candidate to Humira® (adalimumab). The FDA has also announced a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted AVT02 BLA. The BsUFA goal date provided by the FDA is February 24, 2024."

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

Alvotech Tries Again for FDA Interchangeable Designation for Humira Biosimilar (BioSpace) - "Alvotech has resubmitted its Biologics License Application to the FDA seeking an interchangeability designation for AVT02, its high-concentration biosimilar formulation of AbbVie’s Humira (adalimumab), CEO Robert Wessman announced in an investor call....The FDA has already rejected AVT02 twice. The first was in April 2023, with the regulator citing deficiencies at the Iceland facility in its Complete Response Letter. The second rejection came in June, when the FDA turned down Alvotech’s bid for an interchangeability designation for AVT02."

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

Alvotech Provides Regulatory Update on Second Biologics License Application for AVT02 (GlobeNewswire) - "Alvotech...announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s second Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab). As the second of two BLAs submitted for AVT02, this BLA contained data to support approval as a high-concentration biosimilar and additional information to support the interchangeability designation....Alvotech intends to resubmit a BLA for AVT02, including data supporting an interchangeability designation, to the FDA, which would trigger a six-month review period and a new Biosimilar User Fee Act (BsUFA) date."

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

Alvotech and Bioventure Announce Approval of AVT02 (adalimumab) in Egypt (GlobeNewswire) - "Alvotech...and Bioventure...announced that the Egyptian Drug Authority (EDA) has approved the manufacturing and distribution of AVT02 (adalimumab) a biosimilar for Humira®, which is commonly indicated for the treatment of rheumatoid arthritis and several other inflammatory diseases, under the trade name Adalimumab-EVA™."

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

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

Assessing the Interchangeability of AVT02 and Humira in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study. (PubMed, BioDrugs) - P3 | "This study demonstrated that the risk, in terms of safety or diminished efficacy of switching between the biosimilar and the reference product, is not greater than the risk of using the reference product alone, as required by the FDA for interchangeability designation. Beyond the scope of interchangeability, a consistent long-term safety and immunogenicity profile, with no impact on the trough levels up to 52 weeks, was established."

Clinical • Journal • PK/PD data • Dermatology • Immunology • Psoriasis

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

Alvotech Provides Regulatory Update on AVT02 Biologics License Application (GlobeNewswire) - "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 AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab). The CRL noted that certain deficiencies, which were conveyed following the FDA’s reinspection of the company’s Reykjavik facility that concluded on March 17, 2023, must be satisfactorily resolved before the application can be approved. No other deficiencies in the application were noted by the FDA....Alvotech’s second BLA for AVT02, which contains data to support approval as a biosimilar and additional information supporting potential interchangeability designation remains under review by the FDA, with a Biosimilar User Fee Amendment (BsUFA) goal date of June 28, 2023."

BsUFA date • FDA event • Crohn's disease • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Ulcerative Colitis