- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
4M131 MTP: 048 - RA: Biological Agents (A403) - Sep 3, 2019 - Abstract #ACRARHP2019ACR_477;
Further, the first biosimilars have been studied and, at least for an infliximab biosimilar (CT-P13), efficacy and safety appear to be similar to the originator compound...All of these pertinent topics and the latest evidence in biological agents’ use in R A will be explored at this session. Learning Objectives:Describe similarities and differences among approved biologic agentsDiscuss issues around biosimilars Assess the place of biologics in the therapeutic cascade according to updated guidelines
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Humira (adalimumab) / Eisai, AbbVie
Journal: Routinely utilized in-house assays for infliximab, adalimumab and their anti-drug antibody levels. (Pubmed Central) - Sep 1, 2019
Accurate and precise in-house ELISAs, highly comparable with commercial ELISAs and RGAs, were developed and validated for routine analysis of samples of patients treated with IFX (Remicade® or Remsima™) or ADL providing substantial cost benefit. Complex dissociation identified samples with anti-IFX-IFX (3%) and anti-ADL-ADL (14%) complexes indicating the benefit of adding acid dissociation to therapeutic drug monitoring of IFX and ADL.
- |||||||||| cefuroxime / Generic Mfg.
Thrombocytopenia Triggering Troponinemia: A Therapeutic Travesty (Zone 4, Science and Technology Hall) - Aug 21, 2019 - Abstract #AHA2019AHA_7202;
She was on amlodipine and rosuvastatin for hypertension and hyperlipidemia and was a nonsmoker...She was treated for cefuroxime-induced thrombocytopenia with methylprednisone...80 mg atorvastatin was administered...Cardiac complications in TTP have been poorly outlined despite existing data attributing cardiac involvement to be a major cause of mortality. Severe thrombocytopenia may limit coronary intervention but should not preclude the use of mortality lowering drugs namely beta blockers, ACE inhibitors and statins.
- |||||||||| Comtan (entacapone) / Novartis, Orion Corp
Trial completion date, Trial primary completion date: Treatment of Orthostatic Intolerance (clinicaltrials.gov) - Aug 21, 2019
P1/2, N=150, Active, not recruiting,
Severe thrombocytopenia may limit coronary intervention but should not preclude the use of mortality lowering drugs namely beta blockers, ACE inhibitors and statins. Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Clinical, Journal, Real-World Evidence: Infliximab biosimilar CT-P13 is interchangeable with its originator for patients with inflammatory bowel disease in real world practice. (Pubmed Central) - Aug 20, 2019
However, the efficacy parameters were improved, and the treatment continuation rate was not significantly different from that of the naïve patient group. In this interim analysis, CT-P13 was comparable to the originator infliximab with respect to ADRs and efficacy, and is therefore considered to be a cost-efficient interchangeable biosimilar for Japanese patients with inflammatory bowel disease.
- |||||||||| PERSISTENT OBESITY AFTER TREATMENT WITH WEIGHT LOSS MEDICATIONS OR BARIATRIC SURGERY IS A RISK FACTOR FOR DEVELOPMENT OF INFLAMMATORY BOWEL DISEASE (Poster Exhibition - Hall 7) - Aug 18, 2019 - Abstract #UEGW2019UEGW_3435;
Aims & Using IBD Explorys, a HIPPA-enabled web platform that includes clinical data from over 62 million unique individuals with accompanying lab data, we aimed to quantify the risk for new-onset IBD among patients undergoing bariatric surgery (roux-en-y gastrojejunostomy, sleeve gastrectomy or resection, stomach stapling, gastric banding), versus patients being treated with weight loss medications (orlistat, phentermine + topiramate, lorcaserin, naltrexone + bupropion, liraglutide), and the general population (without prior bariatric surgery, weight loss medication exposure, or IBD diagnosis upon entry into Explorys)... Exposure to bariatric surgery and weight loss medications is associated with an increased risk for new-onset IBD compared to the general population, and this is predominately seen among those who fail to normalize their BMI up to 6 months after treatment.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
LONG-TERM FOLLOW-UP OF SWITCHING FROM ORIGINAL INFLIXIMAB TO INFLIXIMAB BIOSIMILAR. REAL WORLD DATA (Poster Exhibition - Hall 7) - Aug 18, 2019 - Abstract #UEGW2019UEGW_1681;
The effectiveness of CT-P13 is equivalent and the risk of serious infectionscould be lower than that of the reference product for infliximab-naive patients with ulcerative colitis. Most of the patients switching from infliximab original maintained CT-P13 at 2 years of follow-up with a good profile of effectiveness and safety.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
IBD BIOSIMILAR TO BIOSIMILAR INFLIXIMAB SWITCHING STUDY: PRELIMINARY RESULTS (Poster Exhibition - Hall 7) - Aug 18, 2019 - Abstract #UEGW2019UEGW_1674;
There are considerably challenges to demonstrate the safety of interchangeability of multiple switches between different biosimilar products. This study has set out examine the outcomes of transitioning from one biosimilar to another biosimilar in a real world cohort of patients.
- |||||||||| Gralise (gabapentin) / Alvogen
Trial completion date, Trial primary completion date: Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures (clinicaltrials.gov) - Aug 15, 2019
P4, N=30, Not yet recruiting,
Switching from entacapone to opicapone led to enhanced efficacy under the conditions of the study. Trial completion date: Jul 2018 --> Jul 2021 | Trial primary completion date: Jun 2018 --> Jun 2021
- |||||||||| Comtan (entacapone) / Novartis, Orion
Journal: Oligomerization and catalytic parameters of human UDP-glucuronosyltransferase 1A10: Expression and characterization of the recombinant protein. (Pubmed Central) - Aug 9, 2019
It was observed that majority of the UGT1A10 protein expressed in HEK293 cells existed in covalently cross-linked higher-order oligomers via formation of intermolecular disulfide bonds, whereas formation of the intermolecular disulfide bonds was not observed in the UGT1A10 protein expressed in CHO cells. Due to the formation of the covalently cross-linked higher-order oligomers, the UGT1A10 protein expressed in HEK293 cells had much lower catalytic activities (particularly the catalytic rate constant kcat) against both morphine and entacapone, compared to the UGT1A10 protein form expressed in CHO cells against the corresponding substrates.
- |||||||||| Gralise (gabapentin) / Alvogen
Enrollment closed, Enrollment change, Metastases: Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy (clinicaltrials.gov) - Aug 9, 2019
P3, N=79, Active, not recruiting,
Due to the formation of the covalently cross-linked higher-order oligomers, the UGT1A10 protein expressed in HEK293 cells had much lower catalytic activities (particularly the catalytic rate constant kcat) against both morphine and entacapone, compared to the UGT1A10 protein form expressed in CHO cells against the corresponding substrates. Recruiting --> Active, not recruiting | N=150 --> 79
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Resolution of Infliximab-Induced Palmar Pustular Psoriasis (PPP) After Switching to Biosimilar Infliximab-DYYB (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_2823;
In studies infliximab led to psoriasis 5-9% compared to 5-12% in infliximab-dyyb. Even though it is believed that both the reference drug and biosimilar drug have similar efficacy and adverse reaction profiles, we hypothesize that our patient may have developed an immunogenic reaction to a part of the infliximab molecule that is not present in its biosimilar product infliximab-dyyb.
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J, Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Entyvio (vedolizumab) / Takeda
A Case of Optic Neuritis in Setting of Starting Infliximab-dyyb in Ulcerative Colitis Patient (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_996;
Infliximab-dyyb was discontinued and she was treated with a course of IV Methylprednisolone and discharged home on Glatiramir acetate...In order to avoid extra-colonic side effects, she was switched to vedolizumab which she has tolerated well...To our knowledge this is the first reported reaction related to a bio-similar. This demonstrates that further studies are needed to estimate the true incidence of demyelinating disorders in patients with IBD and to elucidate if bio-similar may be subject to stronger demyelinating reactions.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Review, Journal: Biosimilars in dermatology: The wind of change. (Pubmed Central) - Aug 7, 2019
The debate over the future of biosimilars is far from being finished. The explosive development of biological therapy and the emergence of biosimilars represent a significant success in the effort to provide advanced healthcare to patients all over the world.
- |||||||||| Journal: Risankizumab (Skyrizi) for psoriasis. (Pubmed Central) - Aug 6, 2019
The explosive development of biological therapy and the emergence of biosimilars represent a significant success in the effort to provide advanced healthcare to patients all over the world. No abstract available
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Trial completion date: ReFLECTt: National Observational Study On The Use Of Inflectra (clinicaltrials.gov) - Aug 6, 2019
P=N/A, N=1200, Recruiting,
No abstract available Trial completion date: Dec 2020 --> Apr 2021
- |||||||||| Comtan (entacapone) / Novartis, Orion
Journal: Improved Bioavailability of Levodopa Using Floatable Spray-Coated Microcapsules for the Management of Parkinson's Disease. (Pubmed Central) - Aug 3, 2019
...In commercial oral formulations, LD is co-administrated with an AADC inhibitor (carbidopa) and a COMT inhibitor (entacapone) to enhance its bioavailability...At the same time, measurements of LD and dopamine of mice administered with this formulation showed enhanced bioavailability of LD. This study highlights a floatable, sustained-releasing delivery system in achieving improved pharmacokinetics data compared to a commercial formulation.
- |||||||||| Gralise (gabapentin) / Alvogen
Enrollment change, Trial termination: Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children (clinicaltrials.gov) - Aug 1, 2019
P2, N=2, Terminated,
Future studies need to focus on cardiovascular disease prevention, mortality and patient-important outcomes instead of biochemical conversion to T2DM. N=40 --> 2 | Active, not recruiting --> Terminated; unable to enroll
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Journal: Biosimilars in Inflammatory Bowel Disease (IBD): Experiences and perceptions of german gastroenterologists (Pubmed Central) - Aug 1, 2019
The European Medicines Agency (EMA) recently approved the first anti-TNF-alpha biosimilar for infliximab (CT-P13) (trade names: Inflectra and Remsima) in Germany...The lower price in comparison to the originator is seen as the most important advantage of biosimilars (71 %). More than two thirds of the survey participants requested specific gastroenterological trials and registries to increase the data available on biosimilars in IBD-patients (68 %).
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Journal: Biosimilars: From extrapolation into off label use. (Pubmed Central) - Aug 1, 2019
However, this potential advantage must be balanced with the awareness that off-label prescribing can potentially expose patients to risky and ineffective treatments. Post-market monitoring is critical to developing long-term evidence to provide assurances on efficacy as well as safety.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Journal: The experience with biosimilars of infliximab in inflammatory bowel disease. (Pubmed Central) - Aug 1, 2019
observational studies seem to confirm biosimilarity in a real-world clinical setting. Current trials are expected to elucidate the remaining doubts about clinical biosimilarity.
- |||||||||| Hervelous (trastuzumab biosimilar) / Hanwha Solutions, Alvogen, Prestige BioPharma, Mundipharma, Dr. Reddy's
Trial primary completion date: TROIKA: A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin (clinicaltrials.gov) - Aug 1, 2019
P3, N=500, Active, not recruiting,
Current trials are expected to elucidate the remaining doubts about clinical biosimilarity. Trial primary completion date: Sep 2019 --> Dec 2019
- |||||||||| Gralise (gabapentin) / Alvogen
Trial completion, Surgery: GRASSP: Gralise (clinicaltrials.gov) - Jul 30, 2019
P4, N=53, Completed,
Trial primary completion date: Sep 2019 --> Dec 2019 Recruiting --> Completed
- |||||||||| Comtan (entacapone) / Novartis, Orion, tolcapone (CRX-1008) / Corino Therap, SOM Biotech, Tasmar (tolcapone) / Endo, Bausch Health
Journal: Effect of the catechol-O-methyltransferase inhibitors tolcapone and entacapone on fatty acid metabolism in HepaRG cells. (Pubmed Central) - Jul 28, 2019
Tolcapone increased mRNA expression of fatty acid transporters, inhibited activation of long-chain fatty acids and impaired VLDL secretion, causing hepatocellular triglyceride accumulation. The findings may be relevant in patients with a high tolcapone exposure and preexisting mitochondrial dysfunction.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Journal: How similar is biosimilar? A comparison of Infliximab therapeutics in regard to charge variant profile and antigen binding affinity. (Pubmed Central) - Jul 19, 2019
We would therefore argue, that analytical comparison is not always a good predictor for clinical interchangeability. Any future regulatory framework for the approval of biosimilars should reflect that the parameters chosen for analytical comparability have to be chosen carefully.
- |||||||||| Stelara (ustekinumab) / J&J, Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Journal: Efficacy of ustekinumab after failure of infliximab CT-P13 in a HLA-Cw6-positive patient affected by pytiriasis rubra pilaris: monitoring with reflectance confocal microscopy (RCM) and optical coherence tomography (OCT). (Pubmed Central) - Jul 17, 2019
Other main clinical features are "islands" of sparing within the affected skin, palmoplantar keratoderma, nail dystrophy, oral involvement and eventually ectropion. The age of onset has a peak between 50 and 70 years but a juvenile presentation is not uncommon.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Journal: CT-P13 biosimilar is non-inferior to infliximab. (Pubmed Central) - Jul 13, 2019
The age of onset has a peak between 50 and 70 years but a juvenile presentation is not uncommon. No abstract available
- |||||||||| Review, Journal: Obesity: Pathophysiology and Management. (Pubmed Central) - Jul 13, 2019
...Fortunately, 5 drug therapies-orlistat, lorcaserin, liraglutide, phentermine/topiramate, and naltrexone/bupropion-are available for long-term weight management...Bariatric surgery yields substantial and sustained weight loss with resolution of type 2 diabetes, although due to the high cost and a small risk of serious complications, it is generally recommended for patients with severe obesity. Benefit-to-risk balance should guide treatment decisions.
- |||||||||| Comtan (entacapone) / Novartis, Orion
Clinical, Journal: Pisa Syndrome in Chinese Patients With Parkinson's Disease. (Pubmed Central) - Jul 10, 2019
However, non-motor symptoms such as depression, anxiety, and cognitive dysfunction have no association with PS in PD. These findings provided important complementary information for identifying the underlying mechanisms of PS.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Primer trabajo OP0277 en #Eular2019 que muestra la posible #intercambiabilidad, de #infliximab innovador a 2 #biosimilares diferentes consecutivos, CT-P13 y Sb2. Remicade, Inflectra y Flixavi. Resultados muy similares al parear perfil de paciente. #AnnRheumDis (Twitter) - Jul 4, 2019
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