Contractors plan US biologic drug facilities

2021 ◽  
Vol 99 (3) ◽  
pp. 13-13
Author(s):  
Michael McCoy
Keyword(s):  
Biologic Drug

Evaluation of Hypersensitivity Reactions in Pediatric Patients Using Biological Drugs

2021 ◽  
pp. 1-8
Author(s):  
Ozge Yilmaz Topal ◽  
Volkan Kose ◽  
Banu Acar ◽  
Umut Selda Bayrakci ◽  
Derya Ozyoruk ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Additional Treatment ◽  
Hypersensitivity Reactions ◽  
Biological Drugs ◽  
Rheumatologic Diseases ◽  
Culprit Drug ◽  
Dose Infusion ◽  
History Of ◽  
Oncologic Diseases ◽  
Biologic Drug

<b><i>Introduction:</i></b> Biological drugs are currently used for the treatment of chronic inflammatory, autoimmune, and neoplastic diseases. With their expanding indication spectrum and increasing use, hypersensitivity reactions to these drugs are also becoming more frequent. The present study aimed to report the incidence and the features of such reactions in pediatric patients using biologicals for the treatment of various diseases. <b><i>Methods:</i></b> The medical records of pediatric patients treated with biological agents between October 1, 2011 and August 31, 2019 were reviewed and adverse reactions were evaluated retrospectively. <b><i>Results:</i></b> During the study period, 211 patients (116 boys, 55%) used 21 different biological drugs for the treatment of various diseases. Their median age at the time of the first treatment was 139.9 (IQR: 92.2–187.8) months. Hematologic-oncologic diseases were the most common indication for biological therapy (97/211; 46.0%), followed by rheumatologic diseases (82/211; 38.9%). Of the 211 patients, 14 (6.64%) experienced reactions to biological drugs. The most common culprit agent was rituximab (57.1%). Most of the patients (85.7%) had a history of reactions either during the infusion or within 1 h after taking the drug. Five patients underwent desensitization to the culprit drug, while 7 other patients continued treatment with a reduced dose/infusion rate or premedication. Also 1 patient continued to take the drug without any additional treatment. <b><i>Conclusion:</i></b> It was reported that 6.64% of the patients who received biologic drug therapy for various reasons in our hospital had hypersensitivity. The most common culprit agent was rituximab, and most of the reactions were immediate reactions.

scholarly journals Biosimilars: State of Clinical and Regulatory Science

2017 ◽  
Vol 20 (1) ◽  
pp. 332 ◽  
Author(s):  
Agnes Victoria Klein ◽  
Jian Wang ◽  
Brian G. Feagan ◽  
Mark Omoto
Keyword(s):  
Controlled Release ◽  
International Collaboration ◽  
Pharmaceutical Sciences ◽  
Canadian Society ◽  
Statistical Equivalence ◽  
Product Monograph ◽  
Regulatory Guidelines ◽  
Clinical Considerations ◽  
Biologic Drug ◽  
Switch Study

On May 12, 2017, various issues and challenges associated with biologics were discussed during a session of the annual joint conference of Canadian Society for Pharmaceutical Sciences and Canadian Chapter of Controlled Release Society at Hyatt Regency Hotel, Montréal, QC, Canada.  An update on the Canadian regulatory guidelines for biosimilars was given, followed by viewpoints expressed by regulatory, academic and industry scientists.  Topics of discussion included: reference biologic drug, clinical considerations, immunogenicity, extrapolation and clarification of terminology, product monograph, international collaboration, switching and interchangeability, naming conventions, clinical and non-clinical evaluation, authorization of indications, statistical equivalence, the nor-switch study and biologics marketplace.

scholarly journals Utility of LC-MS Surrogate Peptide Methodology in the Development of a Combinectin, a Unique Anti-HIV Biologic Drug

2021 ◽  
Vol 7 (3) ◽  
pp. e21007-e21007
Author(s):  
Yulia Benitex ◽  
Jonathan Davis ◽  
David L. Wensel ◽  
Tracy S. Mitchell ◽  
Mark R. Krystal ◽  
...  
Keyword(s):  
Surrogate Peptide ◽  
Anti Hiv ◽  
Biologic Drug

Risk of serious infections in tocilizumab versus other biologic drugs in patients with rheumatoid arthritis: a multidatabase cohort study

2019 ◽  
Vol 78 (4) ◽  
pp. 456-464 ◽  
Author(s):  
Ajinkya Pawar ◽  
Rishi J Desai ◽  
Daniel H Solomon ◽  
Adrian J Santiago Ortiz ◽  
Sara Gale ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cohort Study ◽  
Soft Tissue ◽  
Bacterial Infection ◽  
Opportunistic Infection ◽  
Soft Tissue Infections ◽  
Upper Respiratory Tract ◽  
Biologic Drugs ◽  
Increased Risk ◽  
Biologic Drug

ObjectiveTo investigate the rate of serious bacterial, viral or opportunistic infection in patients with rheumatoid arthritis (RA) starting tocilizumab (TCZ) versus tumour necrosis factor inhibitors (TNFi) or abatacept.MethodsUsing claims data from US Medicare from 2010 to 2015, and IMS and MarketScan from 2011 to 2015, we identified adults with RA who initiated TCZ or TNFi (primary comparator)/abatacept (secondary comparator) with prior use of ≥1 different biologic drug or tofacitinib. The primary outcome was hospitalised serious infection (SI), including bacterial, viral or opportunistic infection. To control for >70 confounders, TCZ initiators were propensity score (PS)-matched to TNFi or abatacept initiators. Database-specific HRs were combined by a meta-analysis.ResultsThe primary cohort included 16 074 TCZ PS-matched to 33 109 TNFi initiators. The risk of composite SI was not different between TCZ and TNFi initiators (combined HR 1.05, 95% CI 0.95 to 1.16). However, TCZ was associated with an increased risk of serious bacterial infection (HR 1.19, 95% CI 1.07 to 1.33), skin and soft tissue infections (HR 2.38, 95% CI 1.47 to 3.86), and diverticulitis (HR 2.34, 95% CI 1.64 to 3.34) versus TNFi. An increased risk of composite SI, serious bacterial infection, diverticulitis, pneumonia/upper respiratory tract infection and septicaemia/bacteraemia was observed in TCZ versus abatacept users.ConclusionsThis large multidatabase cohort study found no difference in composite SI risk in patients with RA initiating TCZ versus TNFi after failing ≥1 biologic drug or tofacitinib. However, the risk of serious bacterial infection, skin and soft tissue infections, and diverticulitis was higher in TCZ versus TNFi initiators. The risk of composite SI was higher in TCZ initiators versus abatacept.

scholarly journals P469 Stay in class or switch out of class after anti-TNF failure in inflammatory bowel disease (IBD). Real-world data from a large district general hospital

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S414-S414
Author(s):  
H Johnson ◽  
S Vythilingam ◽  
S McLaughlin
Keyword(s):  
Clinical Remission ◽  
Disease Type ◽  
Line Treatment ◽  
Second Line ◽  
Real World Data ◽  
Effective Treatment Option ◽  
Significant Cost ◽  
Third Line ◽  
Biologic Drug ◽  
Third Line Treatment

Abstract Background Biosimilar infliximab (IFX) and adalimumab (ADA) are well-proven cost-effective anti-TNF drugs in IBD; in our practice, the majority of patients with IBD receive IFX or ADA first line. Since the introduction of Vedolizumab (VED) and Ustekinumab (UST) some have recommended switching out of class after failing a single anti-TNF. This practice has significant cost implications. To establish the outcome of treatment response in patients treated with a second anti-TNF agent after anti-TNF failure compared with the outcome of patients treated with VED and UST after anti-TNF failure. Methods We maintain a prospective IBD database. We searched our database for the outcomes of patients who failed their first anti-TNF drug but were in a clinical remission 6 months after changing to a second or third biologic drug. Disease type, age, gender and response to their second and third biologic drug were recorded. Clinical remission was defined as off steroids with calprotectin &lt;250 and no symptoms of active IBD. Results Two hundred and eighty-seven patients were identified. One hundred and forty (48.8%) were male. Mean age was 43.2 (range 18–94). Disease type was 75 (26%) UC, 210 (73.2%) CD, 2 (0.7%) IBD-U. One hundred and ninety-three patients received IFX 1st line, 118 (40%) failed. Of these 84 (72%) received ADA, 28 (24%) VED and 6 (5%) UST second line. Remission with second-line treatment was achieved in 58 (69%); ADA, 18 (64%); VED, 6 (100%); UST. Remission with third line treatment; was achieved in 6 (100%); VED; 5 (100%); UST. Ninety-four patients received ADA 1st line, 33 (35%) failed. Of these 11 (33%) received IFX, 10 (30%) VED and 8 (24%) UST second line. Remission with second-line treatment was achieved in 6 (55%); IFX, 10 (100%); VED and 8 (100%); UST. Remission with third line treatment; was achieved in 1 (100%); VED, 4 (100%); UST. Conclusion Our data suggest that treatment with ADA after IFX failure is an effective treatment option whereas IFX treatment after ADA failure is less effective. It is interesting that the majority of those who failed the anti-integrin treatment second line responded to third line ADA. These data are consistent with earlier anti-TNF studies including GAIN (Gauging Adalimumab efficacy in Infliximab Non-responders) and SWITCH (Switch to adalimumab in patients with Crohn’s disease controlled by maintenance infliximab: prospective randomised SWITCH trial) which demonstrated that anti-TNF failure is not a class effect. We recommend prescribing a second anti-TNF after anti-TNF failure in preference to using an anti-integrin second line. This practice will lead to significant cost savings for the health care economy.

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