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Updates On Patent Challenges By Biosimilar Manufacturers At The PTAB - Patent

In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents.

Johnson , Fresenius-kabi , Janssen-biotech-inc , Alexion-pharmaceuticals-inc , Samsung-bioepis-co , Samsung , Biologics-inc , Amgen , Pharmaceuticals-inc , Biocon , Janssen-biotech , Final-written-decision

AbbVie Reports Top-line Results From Phase 3 SEQUENCE Clinical Trial Of Risankizumab

Biopharmaceutical company AbbVie, Inc. (ABBV) announced Tuesday top-line results from the Phase 3 SEQUENCE clinical trial evaluating risankizumab (SKYRIZI, 600 mg intravenous [IV] induction at week 0, 4 and 8 and 360 mg subcutaneous injection [SC] starting at week 12 and every 8 weeks thereafter) versus ustekinumab (STELARA, IV dose at week 0 and 90 mg SC every 8 weeks thereafter) through week 48 in patients with moderately to severely active Crohn's disease who have failed one or more anti-TNFs.

Boehringer-ingelheim , Abbvie-inc , Disease-activity-index , Crohn-39s-disease- , Bbvie , Bbv , Telara- , Iopharmaceutical-company-abbvie , Isankizumab , Kyrizi , Stekinumab

Celltrion Stelara (Ustekinumab) Settlement With J&J - Life Sciences, Biotechnology & Nanotechnology

It has been reported that Celltrion has finalized a settlement with Johnson & Johnson ("J&J") in the United States relating to CT-P43, Celltrion's ustekinumab biosimilar to J&J's STELARA®...

United-states , Johnson , Fresenius-kabi , Samsung-bioepis , Amgen , Mondaq , Alvotech , Mgen , Elltrion , Eal , Ormycon , Resenius-kabi

Biosimilars Licensing Agreement Updates - Life Sciences, Biotechnology & Nanotechnology

Earlier this week, Biocon Biologics Ltd. announced that it has entered into a strategic out-licensing agreement with Yoshindo Inc. to commercialize ustekinumab and denosumab biosimilars...

Japan , Canada , Japanese , Biocon-biologics , Biocon-biologics-ltd , Yoshindo-inc , Biocon , Mondaq , Alvotech , Iocon , Iosimilars-news , Enosumab

Formycon AG and ATHOS KG announce closing of transaction to acquire biosimilar assets FYB201 and FYB202 as well as Bioeq GmbH

10.05.2022 Formycon AG and ATHOS KG announce closing of transaction to acquire biosimilar assets FYB201 and FYB202 as well as Bioeq GmbH | Bioetchnology | Biosimilars | Family Office

Australia , Japan , Canada , Munich , Bayern , Germany , Bioeq-gmb , Melissa-simon , Bioeq-gmbh , Corporate-communications , Genentech-inc , Johnson

Meiji Seika Pharma Co., Ltd.: CORRECTING and REPLACING Meiji Seika Pharma: Promising Results of Phase I Clinical Trial of DMB-3115, a Proposed Ustekinumab Biosimilar, and Initiation of Phase III Clinical Trial in Patients With Plaque Psoriasis


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First paragraph, third sentence of release dated May 20, 2021, should read: Those clinical trials are conducted in collaboration with Dong-A Socio Holdings (Headquarters: Seoul, Korea, CEO: JUNG Jae-Hun, "Dong-A"). (instead of Those clinical trials are conducted in collaboration with Dong-A Socio Holdings (Headquarters: Seoul, Korea, CEO: Jong Hyun Han, "Dong-A").).
The updated release reads:
MEIJI SEIKA PHARMA:
PROMISING RESULTS OF PHASE I CLINICAL TRIAL OF DMB-3115, A PROPOSED USTEKINUMAB BIOSIMILAR, AND INITIATION OF PHASE III CLINICAL TRIAL IN PATIENTS WITH PLAQUE PSORIASIS
Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan, President and Representative Director: Daikichiro Kobayashi, "Meiji") today announced that the bioequivalence of DMB-3115, a proposed ustekinumab biosimilar, has been demonstrated in phase I clinical trial compared to the reference products marketed in Europe and the United States. Meiji also announced the initiation of phase III multi-regional clinical trial in patients with plaque psoriasis. Those clinical trials are conducted in collaboration with Dong-A Socio Holdings (Headquarters: Seoul, Korea, CEO: JUNG Jae-Hun, "Dong-A").

Seoul , Soult-ukpyolsi , South-korea , Japan , Tokyo , United-states , Daikichiro-kobayashi , Kostenloser-wertpapierhandel , Jong-hyun-han , Business-development-dept , Donga-socio-holdings-headquarters , Meiji-seika-pharma-co-ltd