INCHEON

Samsung Bioepis Announces Oral Presentation on Switching Period Results for SB16, a Proposed Biosimilar to Prolia (Denosumab) at the European Calcified Tissue Society (ECTS) Congress 2024

Retrieved on: 
Monday, May 27, 2024
Randomness, Denosumab, Pharmacokinetics, SB16, PD, Month, LSM, Safety, Comparison, DEN, Congress, BMD, Osteoporosis, ECTS, Society, Biosimilar, Annual general meeting, Vaccine

At Month 12, patients were re-randomized into switching period to continue their treatment (SB16+SB16, or DEN+DEN) or switch from DEN to SB16 (DEN+SB16).

Key Points: 
  • At Month 12, patients were re-randomized into switching period to continue their treatment (SB16+SB16, or DEN+DEN) or switch from DEN to SB16 (DEN+SB16).
  • The mean percent (%) change from baseline in lumbar spine bone mineral density (BMD) at Month 18 was comparable between treatment groups.
  • The mean % change from baseline in total hip BMD and femoral neck BMD at Month 18 were comparable between treatment groups.
  • Details of the SB16 abstract presented at ECTS 2024 are as follows:
    A Randomized, Double-blind, Phase III Study to Compare SB16 (Proposed Denosumab Biosimilar) to Reference Denosumab in Patients with Postmenopausal Osteoporosis: 18-Month Results

Samsung Bioepis Gains European Commission Approval For PYZCHIVA™, a Biosimilar to Stelara (Ustekinumab)

Retrieved on: 
Monday, April 22, 2024
Gastroenterology, Safety, Pharmacokinetics, Rheumatology, European Commission, Biosimilar, Partnership, Ustekinumab, Patient, Regulatory affairs, Psoriasis, Civil service commission, Novartis, Dermatology

INCHEON, Korea, April 22, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for PYZCHIVA™, a biosimilar to Stelara1,2 (ustekinumab), paving the way for expanding its immunology portfolio.

Key Points: 
  • INCHEON, Korea, April 22, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for PYZCHIVA™, a biosimilar to Stelara1,2 (ustekinumab), paving the way for expanding its immunology portfolio.
  • PYZCHIVA is approved for the treatment of certain autoimmune disorders in gastroenterology, dermatology and rheumatology.
  • “We are proud to have our fourth immunology biosimilar approved in Europe,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader, at Samsung Bioepis.
  • PYZCHIVA will be commercialized by Sandoz under Samsung Bioepis and Sandoz’s partnership.

Samsung Bioepis Releases Second Quarter 2024 US Biosimilar Market Report

Retrieved on: 
Monday, April 8, 2024
Filgrastim, IRA, Trastuzumab, Pegfilgrastim, ASPS, Growth, Patient, Adalimumab, ASP, Market access, WAC, Medicare, FDA, CMS, Inflation, Economics, Food, Generic drug

The 5th edition explores some IRA implications on biosimilars along with latest price trends, biosimilars market share

Key Points: 
  • The 5th edition explores some IRA implications on biosimilars along with latest price trends, biosimilars market share
    INCHEON, Korea, April 08, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today released its Second Quarter 2024 Biosimilar Market Report , which includes the latest Average Sales Price (ASP) information of all biosimilars and reference products available in the US market.
  • This fifth-edition of the Samsung Bioepis Quarterly Biosimilar Market Report delves into some implications of the Inflation Reduction Act (IRA) with respect to biosimilars, as well as the biosimilars market share and price trends.
  • “Over the past year, we have strived to provide the US market with the latest biosimilar insights through our report, and we are grateful for the positive reception from our readers,” said Thomas Newcomer, Vice President, Head of Market Access, US, at Samsung Bioepis.
  • As of February 2024, adalimumab biosimilar market share has reached 4%, increasing 2% compared to the previous quarter.

Samsung Bioepis Initiates Phase 3 Clinical Trial for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)

Retrieved on: 
Friday, April 5, 2024
Pharmacokinetics, Safety, Patient, Clinical trial, Pharmaceutical industry

INCHEON, Korea, April 05, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced the initiation of Phase 3 clinical trial for SB27, the company's proposed biosimilar referencing Keytrudai (pembrolizumab).

Key Points: 
  • INCHEON, Korea, April 05, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced the initiation of Phase 3 clinical trial for SB27, the company's proposed biosimilar referencing Keytrudai (pembrolizumab).
  • The Phase 3 clinical trial for SB27 is a randomized, double-blind, parallel group, multicenter studyii to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 and Keytruda in patients with metastatic non-squamous non-small cell lung cancer.
  • “We are thrilled to announce the initiation of Phase 3 clinical trial for SB27, after our successful Phase 1 clinical trial initiation in February 2024,” said Ilsun Hong, Vice President, Product Evaluation Team Leader of Samsung Bioepis.
  • “Based on our extensive clinical trial experience accumulated over the years, we will work closely with study investigators to ensure successful completion of the clinical trials for SB27.”

Incheon Metropolitan City, IAIAC, and MITRE Unveil Advanced Air Mobility Concept of Operations

Retrieved on: 
Monday, March 18, 2024
Software, Other Transport, Data Management, Technology, Air, Aerospace, Transport, Manufacturing, Partnership, Travel, Research, Mitre Corporation, MITRE, Concept of operations, Quality of life, Metropolis, City, Airspace, Safety, Atmosphere, South Korea, Airport, AAM

Incheon Metropolitan City, in a landmark partnership with the Institute for Aerospace Industry-Academia Collaboration (IAIAC) and The MITRE Corporation, has released Incheon’s Advanced Air Mobility (AAM) Concept of Operations.

Key Points: 
  • Incheon Metropolitan City, in a landmark partnership with the Institute for Aerospace Industry-Academia Collaboration (IAIAC) and The MITRE Corporation, has released Incheon’s Advanced Air Mobility (AAM) Concept of Operations.
  • The AAM Concept of Operations outlines an approach to AAM integration, with a strong emphasis on safety, community acceptance, and improved mobility.
  • "The integration of AAM operations in Incheon promises to transform our region's transportation landscape,” said Incheon Mayor Jeong-bok Yoo.
  • “This Concept of Operations serves as a roadmap to that future, prioritizing safety, community acceptance, and improved mobility.

Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting

Retrieved on: 
Saturday, March 9, 2024
EMA, Week, Psoriasis, Committee, SB5, Political moderate, Ustekinumab, Organon, FDA, Food, Samsung, BLA, Trial of the century, AAD, Safety, CHMP, Pharmacokinetics, Abstract, Biologics license application, American Academy, Novartis, Interchangeability

“We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.

Key Points: 
  • “We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.
  • The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector of HADLIMA was approved in August 2022.
  • The study showed that efficacy, safety, and immunogenicity between the three arms were comparable up to Week 52.
  • Details of the Samsung Bioepis’ abstracts are as follows:
    Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis: Randomized, Double-blind, Phase III, 52-Week Results

Samsung Bioepis Releases First Quarter 2024 US Biosimilar Market Report

Retrieved on: 
Wednesday, January 17, 2024
Patient, ASP, Adalimumab, Acquisition, Market access, CMS, WAC, Generic drug

Report highlights latest biosimilar pricing and market share status, including state of the adalimumab market

Key Points: 
  • Report highlights latest biosimilar pricing and market share status, including state of the adalimumab market
    INCHEON, Korea, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today released its First Quarter 2024 Biosimilar Market Report which provides most timely information on the current status of biosimilars in the United States.
  • The report also dives into the current state of the adalimumab market, providing insights on how the underutilization of adalimumab biosimilars is delaying the opportunity for cost savings for the US healthcare system.
  • “Despite entry of multiple adalimumab biosimilars in July, the adoption remains stagnant at 2.0% after 6 months.
  • Samsung Bioepis Biosimilar Market Report, which was first published in April 2023, is being published every quarter after the CMS publishes updated ASP values for each product.

Samsung Bioepis Secures US License Date for SB17, a Proposed Biosimilar to Stelara®

Retrieved on: 
Thursday, November 30, 2023
Samsung, Food, Johnson & Johnson, Biologics license application, Ulcerative colitis, Ustekinumab, Patient, Psoriasis, Medicine, BLA, Pharmaceutical industry

In the US, the license period will begin on February 22, 2025.

Key Points: 
  • In the US, the license period will begin on February 22, 2025.
  • Stelara® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis and active psoriatic arthritis.1 SB17, developed by Samsung Bioepis, is a proposed biosimilar to reference medicine Stelara®.
  • The Biologics License Application (BLA) for SB17 is under review by the U.S. Food and Drug Administration.
  • Samsung Bioepis and Sandoz have entered into a development and commercialization agreement for SB17 in September 2023 for the US, Canada, European Economic Area (EEA), Switzerland and United Kingdom (UK).

Ørsted secures 1.6 GW electricity business license for offshore wind project off the coast of Incheon, Korea

Retrieved on: 
Thursday, December 14, 2023
Nature, Wind, Region, Carbon, Energy, Ministry, Climate, Investment, EBL, Senior, Electricity, Renewable energy

Ørsted secures 1.6 GW electricity business license for offshore wind project off the coast of Incheon, Korea

Key Points: 
  • Ørsted secures 1.6 GW electricity business license for offshore wind project off the coast of Incheon, Korea
    Ørsted has been granted a 1.6 GW electricity business license (EBL) by the Ministry of Trade, Industry & Energy of Korea for an offshore wind project located 70 km off the coast of Incheon City.
  • The license grants Ørsted exclusive development rights for its gigawatt-scale Incheon offshore wind project, which is set to become the largest in Korea on completion and will contribute to the country’s goal of being carbon-neutral by 2050.
  • Per Mejnert Kristensen, Senior Vice President and President of Region APAC at Ørsted, says: “At Ørsted, we’re pleased to secure our first electricity business license in Korea.
  • Ørsted has unparalleled capabilities for delivering large-scale offshore wind power projects, and we have a strong track record working with Korean suppliers in our global portfolio over the past decade.

Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA™ (adalimumab-bwwd), a Biosimilar to Humira®

Retrieved on: 
Tuesday, November 7, 2023
FDA, Psoriasis, NYSE, Food, Organon, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, OGN, Pharmacy, Head, Patient, Regulatory affairs, Pharmaceutical industry, Adalimumab

The sBLA was submitted to the FDA by Samsung Bioepis in August 2023.

Key Points: 
  • The sBLA was submitted to the FDA by Samsung Bioepis in August 2023.
  • We remain committed to helping more patients access biosimilar alternatives,” said Jon Martin, Head, US Biosimilars at Organon.
  • HADLIMA (adalimumab-bwwd) was first approved by the FDA in July 2019 as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and prefilled autoinjector.
  • HADLIMA was introduced into the US commercial market on July 1, 2023 and is marketed by Organon.