Abrilada (adalimumab-afzb) / Pfizer - LARVOL DELTA

Antidrug antibodies to adalimumab do not associate with immunologically related adverse events. (PubMed, Front Immunol) - "We characterized the UIR profile of adalimumab (ADL) using data from a phase 3, randomized, interchangeability study of reference ADL (ADL-REF; Humira®) and ADL biosimilar PF-06410293 in patients with rheumatoid arthritis (RA). Presence of ADA (with or without NAb) was associated with lower drug concentrations and faster clearance but not with the development of immunologically related AEs. ClinicalTrials.gov, identifier NCT0423021."

Adverse events • Clinical • Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

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

Adalimumab originator and biosimilars in global inflammatory bowel disease treatment (AGW-GESA 2024) - "Products marketed in Australia, namely Humira, Yuflyma, Idacio, Hyrimoz, Hadlima, Abrilada, and Amgevita, as well as Exemptia in India, provide the most extensive support. Adalimumab products exhibit variations in formulations and associated support programs across different countries. Among the four products offering high-concentration citrate-free formulations, Humira and Xelenka offer a wide range of dosages for different indications. Meanwhile, Xelenka, Yuflyma, and Ardalicip provide the longest room temperature shelf lives, which is favourable for travellers."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics

Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications - an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis. (PubMed, Expert Opin Biol Ther) - "Numbers/types of queries received following regulatory submissions (FDA/EMA, n = 7/n = 5) for seven biosimilars (PF-filgrastim [Nivestym], PF-rituximab [Ruxience®], PF-trastuzumab [Trazimera®], PF-bevacizumab [Zirabev®], PF-pegfilgrastim [Nyvepria®], PF-adalimumab [Abrilada™/Amsparity®], PF-infliximab [Ixifi]) from a single product portfolio were analyzed considering published regulatory authority (RA) guidance and in relation to sections/subsections of Module 3: Quality from the Common Technical Document regulatory dossier and topics based on keyword assignment. Topic assignments included: Control (12-27%/12-28%), Manufacturing (56-72%/34-66%), Stability (1-12%/2-24%), Biosimilarity (5-16%/5-25%), and Container Closure (0-3%/0-9%). The focus of both RAs on topics related to manufacturing and controls is valuable in understanding expectations for scientific and technical content related to gaining biosimilar approval."

Journal

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

Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: a phase 3, open-label, randomised, parallel-group study. (PubMed, Lancet Rheumatol) - P3 | "The risk of multiple switches between reference adalimumab and adalimumab-afzb with respect to diminished efficacy (using pharmacokinetics as a surrogate) or safety is not greater than the risk of using reference adalimumab alone."

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

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

Pfizer approves cross-dose Humira similar… Competition will increase within the year [Google translation] (News The Voice Healthcare) - "Pfizer has received FDA approval for ‘Abrilada’, a biosimilar to Hubira that allows cross-administration, and will launch it within the year. Pfizer announced...that Abrilada, which received FDA approval in November 2019 as a Humira biosimilar, was approved as a crossover product in all indications of Humira."

Biosimilar launch • sBLA • Ankylosing Spondylitis • Crohn's disease • Hidradenitis Suppurativa • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

Biosimilars Are Effective and Safe in Treating Psoriasis (Medscape) - "'After a period of reluctance, the use of biosimilars has gained quite a foothold. This includes new initiatives intended to promote their use. The field of dermatology has been somewhat stagnant in its adoption of such drugs, in part due to the stances held by patient associations and some scientific societies,' said Luigi Naldi, MD..."

Media quote • Psoriasis

Biosimilars for the treatment of psoriasis, effective and safe [Google translation] (Univadis) - "'After a phase of reluctance, the use of biosimilars has taken quite a hold, also in consideration of initiatives aimed at promoting their use. In dermatology there has been a certain inertia connected in part with the positions of patient associations and some scientific societies' commented..."

Media quote • Psoriasis

Psoriasis Biosimilars Appear to Match Up to Original Products, With Caveats (MedPageToday) - "'In the U.S., biologics comprise less than 3% of the volume of drugs on the market, but account for more than one third of all spending,' wrote Luigi Naldi, MD...'The reasons for the high cost of biologics are manifold, including the complexity of their development process, lack of competition, and high demand for their use.'"

Media quote • Psoriasis

Response Rates in Hidradenitis Suppurativa Continue to Climb With New Therapies (MedPageToday) - "'We achieved unprecedented responses with no additional safety signals, and the evidence is certainly compelling to support progressing this drug into phase III development, which is what's happening,' said Papp."

Media quote • Psoriasis

Multiple switching between the biosimilar adalimumab PF-06410293 and high concentration reference adalimumab in combination with methotrexate in patients with moderately to severely active rheumatoid arthritis (AMCP 2023) - No abstract available

Clinical • Combination therapy • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

HS Update: Studies Suggest TNF, IL-17, and JAK inhibitors May Play a Role in Treating HS (Practical Dermatology) - "The TNF blocker adalimumab's (Humira) approval by the US Food and Drug Administration for HS in 2015 opened the floodgates. 'It said there is hope and we have at least a little bit of insight into what is at play on the inflammatory side of things,' Dr. Papp says."

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Hidradenitis suppurativa, innovative therapies and a Sidemast task force of dedicated research experts (PharmaStar) - "On the therapeutic front, if the milder cases range from topical to systemic antibiotics, the severe cases are treated with biological drugs. 'In addition to the already known Adalimumab, a new active ingredient is Secukinumab' explains Prof. Angelo Valerio Marzano...The more the disease becomes known, the more data we collect, in fact thanks to this operation we are also investigating hidradenitis in children and those over 65 and the correlation with tumors.'"

Media quote • Hidradenitis Suppurativa

Hope for Biologic Treatment of Hidradenitis Suppurativa (RheumNow) - "A meta-analysis of trials using biologics [adalimumab (ADA), ustekinumab (UST) and secukinumab (SEC)] in the the management of hidradenitis suppurativa (HS) suggests promising results, but more controlled, rigorous studies are needed....Ribero et a: retrospective study of 31 HS patients treated with SEC - the HiSCR was achieved by 41% of patients at week 28. No adverse events."

Online posting

"What are🌼 Amjevita,🌼 Hadlima, 🌼Cyltezo, 🌼Yusimry,🌼 Hulio, 🌼Hyrimoz, and 🌼 Abrilada" (@ibdtweets)

Multiple Switching Between the Biosimilar Adalimumab PF-06410293 (Abrilada™) and Reference Adalimumab (Humira®)in Combination with Methotrexate in Patients with Moderately to Severely Active Rheumatoid Arthritis (ACR Convergence 2022) - "Results support that the risk of switching between ADL-REF and ADL-afzb in terms of immunogenicity, safety, or possible diminished efficacy (using PK as surrogate) is not greater than the risk of using ADL-REF without the switch."

Clinical • Combination therapy • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Multiple Switching Between the Biosimilar Adalimumab PF-06410293 and High Concentration Reference Adalimumab in Combination with Methotrexate in Patients with Moderately to Severely Active Rheumatoid Arthritis (ASHP 2022) - No abstract available

Clinical • Combination therapy • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Game-changing new treatments evolve for dermatologic conditions - "Afsaneh Alavi, MD, FAAD...said JAK inhibitors are just one among a growing list of new therapies for treating hidradenitis suppurativa, including novel therapeutics such as anti-IL-17 and anti-IL-36, IRAK-4 inhibitors, and anti-neutrophilic agents....Dr. Alavi said that newer therapies such as anti-IL-17 medications have shown even more efficacy."

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Interleukin Inhibitors for Moderate to Severe Psoriasis (HMP Global) - "Dr Armstrong moved on to a discussion of the biologics available to treat plaque psoriasis. The first class is anti-TNα therapies, which 'can work 'upstream' as well as 'downstream.' The FDA-approved TNF inhibitors are etanercept, adalimumab, infliximab, and certolizumab. Next are the FDA approved IL-17 inhibitors: secukinumab, ixekizumab, brodalumab. Secukinumab and ixekizumab have 'identical mechanism of action, binding to IL-17A, and they treat both psoriasis as well as psoriatic arthritis,' stated Dr Armstrong.'"

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Trial Gives New Guidance for Choosing Initial PsA Treatment (Medscape) - P4 | N=NA | '"There are some gaps in our database and our understanding of psoriatic arthritis, compared to rheumatoid arthritis, where we have had many more studies over the years,' Arthur Kavanaugh, MD, told Medscape Medical News when asked to comment on the study."

Media quote • P4 data

Usability Study of PF-06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open-Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis. (PubMed, Rheumatol Ther) - P3 | "All actual PFP users could safely and effectively administer ADL-PF by PFP at each visit, and nearly all participants who completed the sub-study elected to continue study treatment using PFP injections."

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

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA (adalimumab-afzb) Interchangeability (Pfizer Press Release) - "Pfizer Inc...announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022....The PAS was supported by positive topline data from the REFLECTIONS B538-12 study..."

PDUFA date • sBLA • Immunology • Inflammatory Bowel Disease

What’s Coming Down the Psoriasis Pipeline? – An AAD Reading Room selection (MedPageToday) - "'Bimekizumab seems to have at the very least, a slightly higher efficacy than the other two -- definitely higher than secukinumab, and I believe slightly higher than ixekizumab,' said Dr. Bagel...'Bimekizumab is a monoclonal antibody biologic that targets IL-17A and IL-17F. We don't currently have any other type of drug that blocks those two cytokines,' explained Andrew Blauvelt...'The promise of biosimilars is very attractive, in that everyone wants to have a lower-priced biologic to increase access. What we're seeing, however, in the United States is that the cost reductions are only in the 10-20% range compared to the originator,' explained Dr. Blauvelt....According to Dr. Yamauchi, thus far, roflumilast has little to no side effects. 'Really nothing,' he said. 'No tolerability issues, no stinging or burning. It's a pretty tolerable drug without any significant adverse events.'"

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