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Objectives: To better understand the constantly evolving global perspectives on health economics and outcomes research (HEOR), ISPOR conducts surveys among its members and global leaders to capture key methodological and policy HEOR trends expected to significantly impact on health care decision-making. To summarise these trends over time and capture the potential impact of health technology assessment (HTA) processes, we conducted a review of ISPOR's HEOR trends and where we are to-date. Method(s): We systematically searched for trends published by ISPOR between 2018 and 2022 and extracted key information to understand the consistency of trends over time and the evolution of themes. This search was supplemented by identifying key HTA developments and related methodological movements in decision-making in the same period that may have impacted the ranking of trends across years. Results were synthesized qualitatively using infographics. Result(s): Overall, across the last 5 years, 11 different trends were identified. Real-world evidence appeared as the third most influential trend in 2019 and became the number one trend since 2020, whereas drug and healthcare pricing dropped from a key trend in 2018 to 6th position in 2022. Some trends (e.g., biosimilars) only appeared once, due to potentially limited interest or lack of new related methods, whereas other topics (e.g., health equity) regained attention during recent years. Latest research initiatives such as the GetReal Initiative in Europe, HTA collaborations with real-world data organisations (Flatiron), the rise of advanced methodologies (e.g., value-based frameworks) and the recent COVID-19 pandemic may have influenced the appearance, upgrade, or disruption of some of these trends, reflecting changes occurring in HEOR landscape and decision-making. Conclusion(s): Capturing HEOR trends through a representative organisation such as ISPOR is key to understanding past and potential future developments in methods and processes of health policy, considering the wider interplay of contextual and methodological advances.Copyright © 2022
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This industry update covers the period from January 1 through January 31, 2022, and is based on information sourced from company press releases, scientific literature, patents and news websites. January 2022 saw Janssen and Midatech expand their collaboration on bioresorbable polymer microsphere technology for drug delivery. Takeda announced its plans to acquire UK-based Adaptate Biotherapeutics and Gandeeva raised further investment funds to support its drug discovery and development platform focused on the evaluation of protein-drug interactions. Biogen announced that it will sell its stake in a biosimilars joint venture and ABL Bio and Sanofi announced a collaboration around a novel treatment for Parkinson's disease. New regulatory announcements this month included US FDA approvals of a new insomnia treatment for Idorsia and a treatment for atopic dermatitis developed by Pfizer. Insulet gained FDA clearance for a closed-loop insulin pump and Ascendis Pharma followed up its United States approval last year for a once-weekly treatment for growth hormone deficiency with European approval. Pfizer and Ionis announced the discontinuation of the clinical development of a novel cardiovascular drug. In terms of collaborations, Novartis and Alnylam announced they will work together to explore targeted therapies to restore liver function;Scorpion Therapeutics partnered with AstraZeneca to develop novel cancer treatments and Nutriband Inc. and Kindeva Drug Delivery will work together to develop a transdermal fentanyl patch. Collaborations were also announced between Century Therapeutics and Bristol Myers Squibb and Lilly and Entos Pharmaceuticals in the areas of stem cell therapies for cancer treatment and neurology, respectively. A team from the Massachusetts Institute of Technology reported progress in developing oral mRNA treatments and West Pharmaceutical Services published a blog describing the development of a proof-of-principle system for a closed-loop feedback system targeting opioid overdose. A report on the BBC website highlighted the benefits of more sustainable inhalers.
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BACKGROUND: Psoriasis is a chronic inflammatory disease that affects 2% of population. About 0.5–2% of psoriatic cases develop during pediatric age. In most cases, the condition is responsive to topical treatment. However, a small percentage of children require systemic treatment with conventional systemic drugs or biological agents, such as anti-tumor necrosis factor (TNF)-α. Adalimumab (ADA) is an anti-TNF-α recently approved for pediatric psoriasis in the European Union (from 4 years of age, 2015). CASE PRESENTATION: We describe our experience treating a 5-year-old female patient affected by severe plaque psoriasis with ADA biosimilar during SARS-CoV-2 pandemic outbreak also using teledermatology. CONCLUSION: The case reported in this article highlights the safety and the effectiveness of ADA biosimilar MSB11022 (Idacio®) in the treatment of a 5-year-old female affected by plaque psoriasis and paves the way to bigger trials for a more extensive use of TNF-α inhibitor biosimilars for psoriasis in pediatric population.
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Background: Rituximab (anti-CD20 Ab) is the cornerstone of the treatment of non-Hodgkin B lymphomas. Infusion-related reactions (IRR) are the most common adverse effects. To reduce them, intravenous premedication with antihistamine and acetaminophen is administered prior to rituximab. If no IRR after first infusion, subsequent infusions time takes 3-6 hours. Many centers use the rapid 90-minute infusion (off-label). Since 2017 subcutaneous rituximab formulation is available, that takes 5 minutes of administration. Nevertheless, in order to reduce cost, due to approval of biosimilars, some health providers continue using intravenous rituximab. On the other hand, with COVID pandemic, an effort to reduce visits and day-care hospitals stays has been made. In the current situation, it would be convenient to reduce day-care stay and the nursing care burden. We wanted to evaluate the safety of an ultrarapid infusion of biosimilar rituximab in a total time of 30 minutes by analyzing IRR and adverse events (AE). Methods: Since November 2021, 3 cohorts of ultrafast infusion have been studied as follows: One cohort (Cohort 1) with intravenous premedication with dexchlorpheniramine and acetaminophen, followed by rituximab infusion over 1 hour, and 2 cohorts with rituximab infusion over 30 minutes: Cohort 2: with intravenous premedication, and cohort 3 with oral premedication. IRR and adverse events have been independently reviewed and graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (November 27, 2017). Results: 34 patients have been included receiving 48 rituximab infusions (16 infusions in each cohort). Median age was 64 years old (range: 51-91). Diagnostic of NHL were as follows: large b cell: 10;follicular: 13;marginal: 7;mantle cell: 1, Waldeström: 1;Ritcher transformation: 2. Rituximab infusion was in monotherapy (21), and in combination (27) with: bendamustine: 9, CHOP: 17, GEMOX: 1. Considering safety, no IRR has been observed in cohort 1 (1 hour infusion), and 1 IRR grade II in cohort 3 (30 minutes, oral premedication). Other AE were: hypertension grade I and hypotension grade I, both in cohort 2. Conclusions: Ultrarapid rituximab infusion is safe. Oral premedication is feasibly allowing a total infusion time of 30 minutes. This infusion rate alleviates day-care burden saving between 75-90% of time in each rituximab infusion, reduce day-care stay and is comfortable for the patients.
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Background/Aims Coronavirus-2 (SARS-CoV-2) has become a disastrous pandemic since its first outbreak in December 2019. Until 8th of October, 2021, more than 239 million people were infected by COVID-19 leading to over 4.8 million deaths. While vaccines and drugs are two arms in controlling the pandemic, safe and effective vaccines are one of the most reliable interventions to suppress viral transmission. Patients with specific immunological deficits, such as patients with autoimmune diseases or those receiving immunosuppressive need special attention. Besides, vaccination in these patients is problematic due to the probable suppression or over-activation of the immune system. However, there still remain questions about the efficacy and safety of vaccination in immunocompromised patients. Studies are ongoing into the safety and immunogenicity of approved of SARS-CoV-2 vaccines, with regards to immuno-deficient individuals. The aim of this audit was to check the uptake and side effects of the BNT162b2 and ChAdOx1 vaccines. Methods We collected data on 352 patients from routine clinics which included diagnosis, type of vaccine, number of doses, side effects of the vaccines and flare up of arthritis or underlying autoimmune condition. Descriptive statistics were used to analyse the data. Results Of the 352,174 (49%) were Males and 178 (51%) Females. Most common diagnosis was Rheumatoid Arthritis 181 (51%), Axial spondyloarthropathy, 80(23%), Psoriatic Arthritis 65 (18%), GCA 10 (3%), Non-Radiographic Axial Spondyloarthropathy 5 (1.4%), JIA 3 (0.9%), Sarcoidosis 1 (0.3%), and overlap 6 (2%). Medications: 227(65%) patients were on Biosimilars, 26 (7%) on Biologics, 28 (8%) Certolizumab pegol, 21 (6%) Secukinumab, 2 (0.6%) Baricitinib, 3 (0.8%) Abatacept, 29 (8%) Tocilizumab and 16 (4.5%) on Tofacitinib. Vaccination uptake: 329 patients received double dose and 8 received single dose. 15 (4.3%) patients didn't take vaccine. Reasons for not taking vaccine were severe reactions to Arthritis medication and biologics, concerned they may have severe reaction with the vaccine. Some were worried that vaccine may trigger flares, COVID-19 vaccine potentially has tracking chips, didn't trust the vaccine as not gone through enough clinical trialling, lack of any statistics on side effects of the vaccines in immunocompromised patients. Side effects: 146 patients experienced mild side effects based on CTAE5 criteria. Only 3 (2.1%) had severe side effects Grade 3 or above, this included Pulmonary embolism, Stroke, and symptomatic pleural effusion. 15(10%) reported Arthritis flare. Most common side effects were Headache 50(34%), Fatigue 32(22%, Myalgia 32(22%), Fever 30(21%), Chills 30(21%), Injection site pain 28(19%), Rhinorrhoea 11(7.5%), Lethargy 11(7.5%) and maculopapular rash 5(3.4%). Conclusion This audit highlights both the ChAdOx1 and BNT162b2 are safe for use in immune-deficient patients. Immunocompromised patients should be encouraged to take vaccines as benefits of the COVID-19 vaccination outweigh the risks and might reduce the risk of developing severe complications due to COVID-19.
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Some brand drug companies have stymied attempts by generic drug companies to obtain samples of brand drugs needed to develop and gain regulatory approval for their generic products. This conduct, which has been reported in both the US and Canada, raises drug costs to drug plans and other payors and can lessen competition. The literature to date contains little empirical evidence on the prevalence of this conduct, the attendant effects on generic drug market launches and costs incurred by drug payors. This paper addresses these questions for Canada, using data on the drug development projects undertaken by the members of the Canadian Generic Pharmaceutical Association over the period 2015–2019. I found that about 16% of generic drug development projects were delayed due to originator firm efforts to impede access to samples of their drugs. The median generic drug launch delay (among affected drugs) attributable to the challenged conduct was 6 months. The additional costs to drug payors from the resulting delays in generic drug launches over the analysis period was in the order of $284 million, or $57 million annually. This study did not explore the additional generic drug development costs attributable to the challenged conduct.
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Objectives: Recent years have witnessed EU markets updating their biosimilar policies;however, there remain countries where the full cost-savings potential of biosimilars is yet to be realized. This research aims to review the current EU biosimilar landscape, and to investigate the most recent policy shifts as an indicator of expected evolution in the post-COVID environment, as payers express growing interest in healthcare savings. Methods: A qualitative assessment of current EU biosimilar policies was performed, followed by an investigation into emerging global policy shifts, to provide insight into the future direction in which the biosimilar landscape in the EU is shifting. Findings were used to identify trends and predict the changes we should expect in the post-COVID context. Results: The most sophisticated regulatory and pricing environments for biosimilars were identified in Germany and the UK, with policies including regional quotas and reference price groups, respectively. Conversely, markets where streamlined biosimilar access pathways remain lacking include Italy, Spain, Austria, Poland, Romania and Turkey, together with the markets in which there are no legislative measures or recommendations to support uptake at the prescriber-level, such as Bulgaria, Czech Republic, Estonia, Ireland and Slovakia. Investigation of the most recent policy updates highlighted a focus on eradicating barriers to market access. In Italy, a streamlined procedure for pricing and reimbursement of biosimilars was introduced in October 2020. The UK has followed suit and introduced a new licensing pathway specifically for biosimilars, which will not require comparative efficacy data. Beyond EU, Quebec represents one of the example markets that recently announced intention to enforce biosimilar switching, becoming the fourth Canadian province to do so. Conclusions: Emerging policies indicate that future shifts will tackle biosimilar uptake from multiple fronts, with market access policy updates likely to include introduction of abbreviated reimbursement pathways for biosimilars, while switching policies drive uptake at the prescriber-level.
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Background: Currently, asymptomatic patients with CLL/SLL are observed without treatment until development of symptoms or cytopenias. Historically, early intervention studies in patients with CLL/SLL with non-specific chemoimmunotherapy agents have not resulted in an overall survival (OS) benefit and have resulted in toxicity. The introduction of targeted therapies, such as venetoclax (an oral BCL2 inhibitor;V) and obinutuzumab (an intravenous anti-CD20 monoclonal antibody;O), have provided tolerable/efficacious options for patients with CLL. In the CLL14 study, symptomatic patients with CLL receiving frontline therapy with VO had longer progression-free survival (PFS) and deeper remissions [more undetectable minimal residual disease (uMRD)] compared with those receiving chlorambucil and O (Fischer 2019). The CLL-International Prognostic Index (CLL-IPI;Table 1) is a validated prognostic model to predict which patients are at highest risk of a shorter time to first therapy and shorter OS. A score of ≥4 is considered high-risk on this scale. We aim to use VO as early intervention in asymptomatic, high-risk CLL patients, assessed by CLL-IPI, to potentially improve OS and thus alter the natural history of the disease. Methods: On 12/14/20, we activated the S1925 study (NCT#04269902 ) for adult patients with CLL or SLL, who were diagnosed within 12 months of enrollment. Eligible patients have a CLL-IPI score ≥4 (Table 1) or complex cytogenetics (≥3 cytogenetic abnormalities) and do not meet any criteria for initiation of treatment by the International Working Group for CLL (IWCLL;Hallek 2018) guidelines. Enrolled patients are randomized in a 2:1 manner to early versus delayed (at the time IWCLL indication for treatment is met) therapy with VO (Figure 1). VO is administered as previously described (Fischer 2019). The primary endpoint is OS. We hypothesize that early intervention with VO will improve the rate of 6-year OS from 60% to 80%. This design requires 222 eligible patients for 88% power (2-sided a=0.05) for the primary comparison. To allow for 10% ineligibility, we will enroll 247 patients. Estimated accrual time is 4 years. Secondary endpoints include: rates of response, PFS, and relapse-free survival;safety;time to second CLL-directed therapy;and quality of life (assessed by FACT-Leukemia). As COVID19 is an infection with particularly high morbidity and mortality in patients with CLL, incidence of this infection and complications including death will be recorded and compared between patients followed on the early versus delayed intervention arms. The primary translational objective is to evaluate the prognostic association between OS and peripheral blood MRD status at 15 months after treatment initiation by flow cytometry. Secondary translational objectives include describing the association of other clinical outcomes, baseline prognostic factors, and IWCLL-defined response with MRD status at multiple timepoints. Current Status: At the time of submission, 7 patients have been registered and randomized per protocol. Accrual is ongoing. [Formula presented] Disclosures: Stephens: Adaptive: Membership on an entity's Board of Directors or advisory committees;TG Therapeutics: Membership on an entity's Board of Directors or advisory committees;Epizyme: Membership on an entity's Board of Directors or advisory committees;Beigene: Membership on an entity's Board of Directors or advisory committees;Innate Pharma: Membership on an entity's Board of Directors or advisory committees;AstraZeneca: Consultancy;CSL Behring: Consultancy;Celgene: Consultancy;Novartis: Research Funding;Abbvie: Consultancy;JUNO: Research Funding;Arqule: Research Funding;Mingsight: Research Funding;Karyopharm: Membership on an entity's Board of Directors or advisory committees, Research Funding. Moseley: BioSight Ltd: Consultancy. Hill: AbbVie: Consultancy, Honoraria, Research Funding;Gentenech: Consultancy, Honoraria, Research Funding;Beigene: Consultancy, Honoraria, Research Funding;Pfizer: Consultancy, Honoraria;Kite, Gilead Company: Consultancy, Honoraria, Other: Travel Support, Research Funding;Karyopharm: Consultancy, Honoraria, Research Funding;AstraZenica: Consultancy, Honoraria;Celgene (BMS): Consultancy, Honoraria, Research Funding;Novartis: Consultancy, Honoraria, Research Funding;Epizyme: Consultancy, Honoraria;Incyte/Morphysis: Consultancy, Honoraria, Research Funding. Pagel: Pharmacyclics/AbbVie: Consultancy;Actinium Pharmaceuticals: Consultancy;Incyte/MorphoSys: Consultancy;BeiGene: Consultancy;Epizyme: Consultancy;Kite, a Gilead Company: Consultancy;AstraZeneca: Consultancy;Gilead: Consultancy;MEI Pharma: Consultancy. Shadman: Mustang Bio, Celgene, Bristol Myers Squibb, Pharmacyclics, Gilead, Genentech, Abbvie, TG Therapeutics, Beigene, AstraZeneca, Sunesis, Atara Biotherapeutics, GenMab: Research Funding;Abbvie, Genentech, AstraZeneca, Sound Biologics, Pharmacyclics, Beigene, Bristol Myers Squibb, Morphosys, TG Therapeutics, Innate Pharma, Kite Pharma, Adaptive Biotechnologies, Epizyme, Eli Lilly, Adaptimmune, Mustang Bio and Atara Biotherapeutics: Consultancy. Danilov: Genentech: Consultancy, Honoraria, Research Funding;Takeda Oncology: Research Funding;TG Therapeutics: Consultancy, Research Funding;Abbvie: Consultancy, Honoraria;Beigene: Consultancy, Honoraria;Pharmacyclics: Consultancy, Honoraria;Gilead Sciences: Research Funding;Bristol-Meyers-Squibb: Honoraria, Research Funding;Rigel Pharm: Honoraria;Bayer Oncology: Consultancy, Honoraria, Research Funding;SecuraBio: Research Funding;Astra Zeneca: Consultancy, Honoraria, Research Funding. Mato: Pharmacyclics LLC, an AbbVie Company: Consultancy, Research Funding;DTRM BioPharma: Consultancy, Research Funding;Acerta/AstraZeneca: Consultancy, Research Funding;Sunesis: Consultancy, Research Funding;BeiGene: Consultancy, Research Funding;Johnson and Johnson: Consultancy, Research Funding;Genentech: Consultancy, Research Funding;AbbVie: Consultancy, Research Funding;Nurix: Research Funding;Genmab: Research Funding;LOXO: Consultancy, Research Funding;Janssen: Consultancy, Research Funding;AstraZeneca: Consultancy;Adaptive Biotechnologies: Consultancy, Research Funding;MSKCC: Current Employment;TG Therapeutics: Consultancy, Other: DSMB, Research Funding. Brander: Juno Therapeutics/Celgene/Bristol Myers Squibb: Research Funding;Pfizer: Consultancy, Other: Biosimilars outcomes research panel;TG Therapeutics: Consultancy, Research Funding;Novartis: Research Funding;ArQule/Merck: Consultancy;Verastem: Consultancy;BeiGene: Research Funding;ArQule: Research Funding;NCCN: Other: panel member;AstraZeneca: Research Funding;Pharmacyclics LLC, an AbbVie Company: Consultancy, Research Funding;LOXO: Research Funding;Ascentage: Research Funding;Genentech: Consultancy, Research Funding;DTRM: Research Funding;MEI Pharma: Research Funding;AbbVie: Consultancy, Other: informCLL registry steering committee, Research Funding. Coutre: Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding;Pharmacyclics: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding;AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding;AstraZeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees;Beigene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Data Safety Monitoring Committee, Research Funding;Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees;Acerta: Other: Data Safety Monitoring Committee, Research Funding. O'Brien: Kite, Regeneron, Acerta, Caribou, Gilead, Pharmacyclics, TG Therapeutics, Pfizer, Sunesis: Research Funding;Amgen, Astellas, Celgene, GlaxoSmithKline, Janssen Oncology, Aptose Biosciences Inc., Vaniam Group LLC, AbbVie, Alexion, Verastem, Juno Therapeutics, Vida Ventures, Autolus, Johnson and Johnson, Merck, Bristol Myers Squibb, NOVA Research Company, El Lill: Consultancy. Erba: AbbVie Inc;Agios Pharmaceuticals Inc;Bristol Myers Squibb;Celgene, a Bristol Myers Squibb company;Incyte Corporation;Jazz Pharmaceuticals Inc;Novartis: Speakers Bureau;AbbVie Inc: Other: Independent review committee;AbbVie Inc;Agios Pharmaceuticals Inc;ALX Oncology;Amgen Inc;Daiichi Sankyo Inc;FORMA Therapeutics;Forty Seven Inc;Gilead Sciences Inc;GlycoMimetics Inc;ImmunoGen Inc;Jazz Pharmaceuticals Inc;MacroGenics Inc;Novartis;PTC Therapeutics: Research Funding;AbbVie Inc;Agios Pharmaceuticals Inc;Astellas;Bristol Myers Squibb;Celgene, a Bristol Myers Squibb company;Daiichi Sankyo Inc;Genentech, a member of the Roche Group;GlycoMimetics Inc;Incyte Corporation;Jazz Pharmaceuticals Inc;Kura Oncology;Nov: Other: Advisory Committee. OffLabel Disclosure: The trial studies early intervention with venetoclax and obinutuzumab in patients with CLL/SLL who are asymptomatic and observation would be standardly recommended.
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Case report-IntroductionPanniculitides comprise a heterogeneous group of inflammatory diseases involving the subcutaneous fat. They remain the most challenging areas for clinicians. Skin biopsy is commonly needed to confirm diagnosis. Because there are many underlying aetiologies for panniculitis, detailed history and thorough investigations are needed. We present a case of A 20-year male who was admitted with painful lumps treated initially as cellulitis/abscess but turned to be neutrophilic panniculitis on skin biopsy. Extensive workup failed to reveal underlying aetiology. Eventually Imradli (AntiTNF) was thought to be the culprit and therefore was kept on hold with no recurrence of panniculitis.Case report-Case descriptionA 20-year-old, Asian Malawian. Moved to the UK at the age of 6. He was diagnosed with Ankylosing spondylitis in November 2016. Initially received Naproxen followed by (Humira) with good clinical response. He was switched to biosimilar Imradli in Nov 2019. He was admitted with 2-3 weeks history of progressive right hip and buttock pain, 1 week of very tender erythematous swelling of the right buttock but without fever or weight loss. He reported mild weakness of lower limbs. Physical examination revealed 5x 8 cm swelling on Right buttock, Rest of examination was unremarkable. He was reviewed by neurology team who arranged MRI spine and brain, EMG and lumbar puncture which all came back as unremarkable excluding the possibilities of myelitis and myositis. Initially thought to be abscess/cellulitis but absence of fever/inflammatory response, abnormal CT finding and no response to antibiotics made it less likely. While the Right buttock erythema/swelling started to resolve, he developed two new migratory erythematous lesions appearing around the left buttock and lower lumbar spine. Working diagnosis of panniculitis was made which was confirmed on biopsy. Due to lack of response to NSAIDs, colchicine or oral steroids, a 3rd biopsy of the freshest lesion was performed to exclude deep-seated infection.Investigations-FBC, U&ES, LFT, CRP, CK, ACE-all were unremarkableASO titre <200, serology for Borrelia and TPHA negative.Viral, parasitic, and Autoimmune screen were unremarkable.CXR clear, MRI/CT: extensive subcutaneous inflammatory changes in the right buttock with sacral oedema.PET-CT-showed resolving inflammatory changes in the right flank, FDG intake in C6 and SI joints presumed secondary to ankylosing spondylitis and sacroiliitis.The underlying cause of panniculitis remains uncertain. Anti TNF was kept on hold and the patient was followed up with no evidence of recurrence of panniculitisCase report-DiscussionPanniculitis (inflammation of subcutaneous fat) is a relatively uncommon condition. It has various aetiologies including infection, trauma, inflammation, and malignancy. Skin biopsy can give valuable information including microbiological studies if infectious panniculitis was suspected. However, clinical correlation and careful consideration of the differential diagnosis is needed in many cases.The diagnosis can be quite challenging as in this case where all investigations and skin biopsy could not point towards the underlying aetiology. Although anti-TNF inhibitors are commonly used in treating a wide range of autoimmune conditions. But their use can lead to the development of secondary autoimmune diseases, such as cutaneous vasculitis, lupus-like syndrome, and interstitial lung disease, paradoxically induced by anti-TNF-a agents. Llamas-Velasco and Requena, reported the first case of panniculitis induced by etanercept injection in a 62-year-old woman with severe psoriasis who developed an erythematous, slightly painful nodule on the skin of the anterior abdominal wall.Adalimumab induced lupus panniculitis was reported in a Rhu-lupus patient. Although the lesions stopped progressing after cessation of adalimumab, they remained unchanged for two more years. The mechanism for adalimumab-induced CLE is uncertain.Although there is not enough data about autoimmunity with biosimilars, we think seco dary autoimmune conditions could similarly be induced by biosimilar as illustrated in this case. Anti-TNF induced cutaneous panniculitis is considered most likely although uncertain. If anti-TNF drug-induced, this should gradually resolve but can be slow (4-6 months). Corticosteroids have been added for an anti-inflammatory response, but there was little benefit which might point to a different pathogenetic mechanism.NSAIDs has helped to keep his AS relatively stable during the COVID-19pandemic. During the last review, the patient expressed his wishes to go back on biologic. But the question remains whether he will a have a recurrence of panniculitis or not?Case report-Key learning points1/Anti-TNF inhibitors sometimes cause secondary autoimmune conditions like cutaneous vasculitis, lupus-like syndrome, but there is not enough data regarding biosimilar induced autoimmunity.2/This case illustrates the high importance of having a tissue diagnosis. (whenever there is an issue, the diagnosis would be in the tissue).3/There is still uncertainty whether a recurrence of panniculitis might occur or not if the patient went again on biologics.