- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Clinical, Observational data, Journal: Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life multicenter, observational study in Italian primary inflammatory bowel disease centers. (Pubmed Central) - Jul 3, 2019
Switching from IFX originator to biosimilar did not influence the maintenance of the clinical remission. This study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD, in both naïve patients and those switching from IFX originator.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Clinical, Journal, Real-World Evidence: Biosimilar CT-P13 in treating ulcerative colitis in the real world. (Pubmed Central) - Jun 28, 2019
These results suggested a beneficial potential that ZNS preserves striatal presynaptic DAT expression and slows disease progression in early-stage PD. No abstract available
- |||||||||| Journal, HEOR: Incremental cost-effectiveness of evidence-based non-surgical weight loss strategies. (Pubmed Central) - Jun 28, 2019
Despite several newly available interventions, Weight Watchers Meetings is currently the only evidence-based, commercially available, cost-effective option for non-surgical weight loss. Other interventions, specifically medications, are more effective but priced too high to be cost-effective.
- |||||||||| Cyclurad (cycloserine/lurasidone) / NRx Pharma, Alvogen
Biomarker, Enrollment closed: NRX-GLX: NRX101 Glx Biomarker Validation Study (clinicaltrials.gov) - Jun 18, 2019
P2/3, N=24, Active, not recruiting,
Not yet recruiting --> Active, not recruiting | Trial completion date: Mar 2020 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Sep 2020 Recruiting --> Active, not recruiting
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Journal: Lower circulating levels of CTRP12 and CTRP13 in polycystic ovarian syndrome: Irrespective of obesity. (Pubmed Central) - Jun 7, 2019
Our results indicated that decreased adiponectin, CTRP12, and CTRP13 levels, regardless of obesity, could independently predict PCOS. This finding suggested a novel link between adipokines and PCOS.
- |||||||||| Hervelous (trastuzumab biosimilar) / Hanwha Solutions, Alvogen, Prestige BioPharma, Mundipharma, Dr. Reddy's
Trial completion date, Trial primary completion date: TROIKA: A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin (clinicaltrials.gov) - Jun 7, 2019
P3, N=500, Active, not recruiting,
This finding suggested a novel link between adipokines and PCOS. Trial completion date: Apr 2020 --> Oct 2019 | Trial primary completion date: Apr 2019 --> Sep 2019
- |||||||||| Comtan (entacapone) / Novartis, Orion
PK/PD data, Journal: Pharmacodynamic Evaluation of novel Catechol-O-methyltransferase Inhibitors. (Pubmed Central) - Jun 6, 2019
The cytotoxicity of tolcapone and CNCAPE in human neuroblastoma SK-N-SH cells and human liver adenocarcinoma SK-HEP-1 cells was also assessed. At lower concentrations, CNCAPE did not reduce cell viability, suggesting that CNCAPE may have a potential therapeutic role as a centrally active COMT inhibitor.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Journal, HEOR: Comparative effectiveness of the biosimilar CT-P13. (Pubmed Central) - Jun 5, 2019
For the other extrapolated indications, many observational induction and switching studies also support the utility of CT-P13 in the treatment of inflammatory diseases. Here, we review profiles of CT-P13 including physicochemical properties, clinical efficacy and safety data in all indications and current status.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical: As in how long it takes for the temporary symptoms of receiving the drug to wear off (in my case, very mild muscle aches on Remicade, but haven't had these at all with either Remsima or Flixabi). (Twitter) - Jun 2, 2019
- |||||||||| Qsymia (topiramate + phentermine) / Vivus
Clinical, FDA event, Journal: Intragastric Balloon Treatment for Obesity: FDA Safety Updates. (Pubmed Central) - May 30, 2019
Since January 1, 2006, ORBERA and Reshape IGB have been implicated in 33 deaths. Given the cited evidence, we recommend FDA withdrawal of these two devices.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical: Two ifx biosimilars approved in Canada. Inflectra (Pfizer) and Renflexis (Merck). Will be up to the individual MD’s to decide. Will be interesting to see which company picks up more market share. (Twitter) - May 29, 2019
- |||||||||| Victoza (liraglutide) / Novo Nordisk
Review, Journal: Gender-related issues in the pharmacology of new anti-obesity drugs. (Pubmed Central) - May 26, 2019
Four new medicines-liraglutide, lorcaserin, bupropion/naltrexone, and phentermine/topiramate-have been recently added to the pharmacological arsenal for obesity treatment and could represent important tools to manage this epidemic disease...Although evidence from premarketing clinical studies suggested that no dose adjustment by gender is necessary for any of these new medicines, these studies were not specifically designed to identify gender-related differences. This observation, together with the strong theoretical background supporting the hypothesis of a gender-dimorphic response, strongly call upon an urgent need of new real-life data on gender-related difference in the pharmacology of these new obesity drugs.
- |||||||||| amlodipine/rosuvastatin (DP-R212) / Alvogen
Journal: Lisinopril, Amlodipine, Rosuvastatin as a Novel Fixed Combination in the Fight Against Cardiovascular Disease (Pubmed Central) - May 17, 2019
The efficacy of each of the components and their combined administration in primary and secondary prevention of cardiovascular disease has been demonstrated in clinical studies. The convenience of several drugs combination in a single tablet increases adherence to therapy facilitating regular intake of all treatment components and reliably reducing the risk of cardiovascular complications.
- |||||||||| Victoza (liraglutide) / Novo Nordisk, semaglutide SC once-daily (NN9536) / Novo Nordisk
Review, Journal: Centrally Acting Agents for Obesity: Past, Present, and Future. (Pubmed Central) - May 17, 2019
Another potential new pharmacotherapy, setmelanotide, is a melanocortin-4 receptor agonist, which is still in an early stage of development. As our understanding of the communication between the CNS, gut, adipose tissue, and other organs evolves, it is anticipated that obesity drug development will move toward new centrally acting combinations and then to drugs acting on peripheral target tissues.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Clinical, Observational data, Journal: Long-term Outcomes After Switching to CT-P13 in Pediatric-Onset Inflammatory Bowel Disease: A Single-Center Prospective Observational Study. (Pubmed Central) - May 11, 2019
Twenty-seven adverse events occurred in the maintenance group and 30 in the switch group. Switching from maintenance infliximab RP to CT-P13 did not result in any significant differences in efficacy, pharmacokinetics, or immunogenicity in patients with pediatric-onset IBD, and no unexpected safety issues occurred, supporting findings from randomized controlled trials.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Journal: Full Interchangeability in Regard to Immunogenicity Between the Infliximab Reference Biologic and Biosimilars CT-P13 and SB2 in Inflammatory Bowel Disease. (Pubmed Central) - May 11, 2019
Findings suggest that immunodominant epitopes in the reference and CT-P13 drugs are equally present in SB2. Data support full interchangeability between biosimilars in regard to immunogenicity.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Journal: Infliximab biosimilar CT-P13 for inflammatory bowel disease. (Pubmed Central) - May 11, 2019
Data support full interchangeability between biosimilars in regard to immunogenicity. No abstract available
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Clinical, P3 data, Journal, Head-to-Head: Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study. (Pubmed Central) - May 7, 2019
P3
This study showed non-inferiority of CT-P13 to infliximab in patients with active Crohn's disease. Biosimilar CT-P13 could be a new option for the treatment of active Crohn's disease.
- |||||||||| Retrospective data, Journal: Cardiovascular Risk Reduction Associated with Pharmacological Weight Loss: A Meta-Analysis. (Pubmed Central) - May 7, 2019
...Key words used included: "orlistat", "lorcaserin", "phentermine/topiramate" or "naltrexone/bupropion" and "cardiovascular outcomes" among others...Our data suggests pharmacological weight loss therapy may be a valuable treatment option to reduce CVD risk in obese patients. Further research is needed to clarify the effects these therapies on overall mortality and evaluate the mechanisms by which these medications reduce CVD risk factors and mortality.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Journal: Infliximab biosimilar CT-P13 in Crohn's disease. (Pubmed Central) - May 2, 2019
Not yet recruiting --> Recruiting No abstract available
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Clinical, P4 data, Journal, Head-to-Head: Serum concentrations after switching from originator infliximab to the biosimilar CT-P13 in patients with quiescent inflammatory bowel disease (SECURE): an open-label, multicentre, phase 4 non-inferiority trial. (Pubmed Central) - Apr 28, 2019
P4
Switching to CT-P13 is safe and well tolerated in patients with inflammatory bowel disease in remission. Future trials should assess switching to CT-P13 in patients with active disease.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Review, Journal: Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective. (Pubmed Central) - Apr 27, 2019
However, efficacy and safety data on Flixabi (SB2) in IBD patients is lacking. Switching from the originator to a biosimilar in patients with IBD is acceptable, although scientific and clinical evidence is lacking regarding reverse switching, multiple switching and cross-switching among biosimilars in IBD patients.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Clinical, Review, Journal: Switching from an originator anti-TNF to a biosimilar in patients with inflammatory bowel disease: Can it be recommended? A systematic review. (Pubmed Central) - Apr 26, 2019
On the contrary, a steadily increasing number of publications have shown that there seem to be no safety or efficacy concerns about switching. Therefore, switching from originator to biosimilar infliximab in patients with IBD may be considered acceptable.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Journal: Recent advances in the treatment of rheumatoid arthritis. (Pubmed Central) - Apr 19, 2019
With remission increasingly attainable, effective drug tapering strategies are needed. Although tapering trials do exist, more studies will be needed to help guide clinical practice.
- |||||||||| Comtan (entacapone) / Novartis, Orion
Clinical, Journal: Prescribing patterns of antiparkinson drugs in a group of Colombian patients, 2015 (Pubmed Central) - Apr 18, 2019
The most commonly used association was levodopa/carbidopa + entacapone (n=311; 10.7%)...Most were employed in the usual recommended doses. It is necessary to explore the clinical effectiveness of the medications studied and differentiate between disease and parkinsonian syndromes subtypes.
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Enrollment open: To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis (clinicaltrials.gov) - Apr 17, 2019
P3, N=270, Recruiting,
It is necessary to explore the clinical effectiveness of the medications studied and differentiate between disease and parkinsonian syndromes subtypes. Not yet recruiting --> Recruiting
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Journal: Switching to biosimilars in the treatment of rheumatic diseases. (Pubmed Central) - Apr 9, 2019
Expert Commentary: Clear guidelines for switching and data from post-marketing surveillance and registries will be required to confirm existing results on the safety and efficacy of switching from bio-originators to biosimilars. To lessen the nocebo effect against biosimilars, effective educational programs should be provided for all stakeholders, including patients and physicians.
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