Other Posts
Stelara (ustekinumab) / J&J
Janssen Demonstrates Strong Commitment To Research And Development Of Therapies For Inflammatory Bowel Diseases With Nine Data Presentations At ACG 2020(PRNewswire) - Oct 19, 2020 - "Featured among the eight poster presentations and one oral presentation are final five-year data from the IM-UNITI open-label long-term extension (LTE)study...Other notable presentations at ACG include data from the Phase 3 UNIFIstudy...Data will be presented from the long-term extension study out to two years, including an abstract showing the effect of the treatment on stool frequency and rectal bleeding."
Remicade (infliximab)/ Mitsubishi Tanabe, J&J; Humira (adalimumab) / Eisai, AbbVie; Xeljanz(tofacitinib) / Pfizer, Marche Polytechnic University; Stelara (ustekinumab)/ J&J; Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe,J&J; Entyvio (vedolizumab) / Takeda; Inflectra (infliximabbiosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer; Remaloce(infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
ICER: Infliximab Is Highest in Cost-Effectiveness for UC (Center for Biosimilars) - Oct 19, 2020 - "Areport from the Institute for Clinical and Economic Review (ICER) found that of6 targeted immune modulators (TIMs), infliximab molecules are the most cost-effective for ulcerative colitis (UC), largely thanks to biosimilar competition....An estimated 900,000 individuals in the United States have UC, and the estimated economic burden is $15 billion to $32 billion in lost work, schooling, and productivity, ICER said....The group found that infliximab biosimilars had superior cost-effectiveness in the treatment-naïve patient population...The lowest cost infliximab biosimilar by annual wholesale acquisition cost (WAC)was Renflexis ($18,000)."
NeuLara (ustekinumabbiosimilar) / NeuClone, Serum Institute of India
NeuClone Announces Positive Results from Phase I Study of Stelara (ustekinumab)Biosimilar Candidate (Businesswire)- Oct 20, 2020 - P1; N=210; Sponsor: NeuClone Proprietary Limited;"NeuClone Pharmaceuticals Ltd (NeuClone) today announced its biosimilar candidate of Stelara® (ustekinumab), NeuLara, has successfully met all primary and secondary endpoints in a Phase I clinical trial. This includes all pre-specified criteria demonstrating the clinical pharmacokinetic (PK)similarity of NeuLara, compared to US- and EU-sourced Stelara®....'We are on track for a global Phase III trial starting in 2021 and to be among the first biosimilar entrants, making this valuable antibody drug available to many more patients with psoriasis and inflammatory bowel diseases.'"
XeljanzXR (tofacitinib XR) / Pfizer
ZydusCadila receives tentative approval from USFDA for Tofacitinib Extended-Release Tablets (Zydus Cadila Press Release)- Oct 19, 2020 - "Zydus Cadila has received tentative approval from the USFDA to market Tofacitinib Extended-Release Tablets, 11 mg (US RLD: XeljanzXR® Tablets). It is recommended for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis (UC)."
Humira (adalimumab)/ Eisai, AbbVie; Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; Rinvoq(upadacitinib) / AbbVie
4 AbbVie brands land on pharma's top TV spenders list for September (Fierce Pharma) - Oct 19, 2020 - "AbbVie’s Humira led the way as usual, but with an even bigger budget of $57.7million...Overall, September spending among the top 10 was up 23% over August's$148 million...4. Descovy: Total estimated spending: $13.7 million (down from$13.7 million in August); 6. Skyrizi: Total estimated spending: $11.3 million(up from $8.5 million in August); 7. Rinvoq: Total estimated spending: $10.7million..."
ontamalimab(SHP647) / Takeda
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) (clinicaltrials.gov) - Oct 20, 2020 - P3; N=451; Recruiting;Sponsor: Shire; N=3384 --> 451; Trial completion date: Jun 2025 --> Dec2023; Trial primary completion date: Feb 2025 --> Dec 2023
mirikizumab(LY3074828) / Eli Lilly
LUCENT2: A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov)- Oct 19, 2020 - P3; N=1044; Recruiting; Sponsor: Eli Lilly and Company; Trial primary completion date: Mar 2021 --> Nov 2021
mirikizumab(LY3074828) / Eli Lilly
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1) (clinicaltrials.gov)- Oct 19, 2020 - P3; N=1160; Recruiting; Sponsor: Eli Lilly and Company; Trial primary completion date: Sep 2020 --> Jan 2021
Xeljanz(tofacitinib) / Pfizer, Marche Polytechnic University
Xeljanz: Newly added patents in Orange Book (OrangeBook) - Oct 24, 2020 - Expiry on December 8, 2020 and December 8,2025
Participant Preferences in the Treatment of Inflammatory Bowel Disease (IBD) in Europe(clinicaltrials.gov) - Oct 22, 2020 - P;N=600; Not yet recruiting; Sponsor: Takeda
