Pegfilgrastim

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.

Accord BioPharma, Inc. Announces U.S. FDA Acceptance of Biologics License Application for Proposed STELARA® Biosimilar DMB-3115

Retrieved on: 
Thursday, January 4, 2024
Biology, Partnership, Food, Pegfilgrastim, Johnson & Johnson, Trastuzumab, Crohn's disease, FDA, Filgrastim, Ulcerative colitis, PASI, Intas Pharmaceuticals, Ustekinumab, Patient, Safety, Psoriasis, Medicine, BLA, Pharmaceutical industry

DURHAM, N.C., Jan. 4, 2024 /PRNewswire/ -- Accord BioPharma, Inc. the U.S. specialty division of Intas Pharmaceuticals Ltd. focused on development of oncology, immunology, and critical care therapies, announced today the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115. DMB-3115 is a proposed biosimilar to STELARA®, a blockbuster drug developed by Janssen Biotech, Inc. and approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. In the U.S., STELARA recorded $13.9 billion in sales (IQVIA Sales in 2022) and is one of the best-selling biologics.

Key Points: 
  • In the U.S., STELARA recorded $13.9 billion in sales (IQVIA Sales in 2022) and is one of the best-selling biologics.
  • The announcement of DMB-3115's BLA acceptance comes as Accord BioPharma awaits a string of additional regulatory milestones.
  • The company has submitted three separate Biologics License Applications to the FDA for biosimilar versions of trastuzumab, pegfilgrastim, and filgrastim.
  • Accord BioPharma is planning to introduce several additional biosimilars to the U.S. market during the next five years.

Human medicines European public assessment report (EPAR): Dyrupeg, pegfilgrastim, Status: Withdrawn application

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, Febrile neutropenia, Filgrastim, Agency, Fever, Pegfilgrastim, Infection, Bone marrow, ATC, EMA, Biosimilar, International, European, Blood, Certification, Clinical trial, Cancer, GMP, Neutrophil, European Medicines Agency, Syndrome, Review, Patient, Safety, Anatomy, Medicine, Leukemia, Skin, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Dyrupeg, pegfilgrastim, Status: Withdrawn application

Key Points: 


Human medicines European public assessment report (EPAR): Dyrupeg, pegfilgrastim, Status: Withdrawn application

Coherus Announces FDA Approval of UDENYCA ONBODY™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv

Retrieved on: 
Tuesday, December 26, 2023
Febrile neutropenia, Food, Risk, Pegfilgrastim, Infection, CHRS, Caregiver, Physician, Research, FDA, De novo, Incidence, Cancer, Needlestick injury, PD, Patient, OBI, Biosimilar, Pharmaceutical industry

REDWOOD CITY, Calif., Dec. 26, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) approved UDENYCA ONBODY™, the company's on-body injector (OBI) presentation of UDENYCA® (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

Key Points: 
  • “The on-body injector for UDENYCA is the result of years of significant investment in research and development to bring forward a novel and proprietary device that provides patients with an automatic delivery option for their medication,” said Denny Lanfear, CEO of Coherus.
  • We expect that UDENYCA ONBODY’s five-minute injection time and innovative retractable needle mechanism will be well received by cancer patients, their caregivers, and doctors,” said Paul Reider, Coherus’ Chief Commercial Officer.
  • “Our state-of-the-art UDENYCA ONBODY device is unlike other approaches in that it is not adapted or repurposed from other medical uses,” said Rich Hameister, Coherus’ Chief Technical Officer.
  • Commercial availability of UDENYCA ONBODY is planned for the first quarter of 2024.

BeyondSpring and Leading Cancer Center Present Poster Highlighting Plinabulin’s Ability to Reduce Infectious Neutropenic Fever for Multiple Myeloma Patients Undergoing AHCT

Retrieved on: 
Wednesday, June 7, 2023
Neutropenia, Platelet transfusion, RBC, IV, Multiple myeloma, Pegfilgrastim, Fever, Assistant, MS, ASCO, American Society of Clinical Oncology, Patient, Memorial Sloan Kettering Cancer Center, Annual general meeting, Drug discovery, MM, MSK, Toxic leukoencephalopathy, Principal, Melphalan, Society, Pharmaceutical industry, Blood product, MD, Plinabulin

BeyondSpring and Memorial Sloan Kettering Cancer Center (MSK) presented the data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting .

Key Points: 
  • BeyondSpring and Memorial Sloan Kettering Cancer Center (MSK) presented the data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting .
  • Between January 2022 and February 2023, 15 patients with a median age of 64 received Plinabulin after a high dose of melphalan.
  • The Plinabulin and pegfilgrastim combination appears well tolerated without additional major toxicities post AHCT.
  • “The Plinabulin-pegfilgrastim combination represents a new potential supportive care for MM patients undergoing AHCT.

Dr. Reddy’s Successfully Completes Phase I Study (IV Route) of DRL_TC, a Proposed Biosimilar of Tocilizumab

Retrieved on: 
Monday, June 5, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, BSE, Rituximab, Clinician Administered PTSD Scale, Therapy, Clinical trial, RDY, Pegfilgrastim, Rheumatoid arthritis, NSE, Tocilizumab, Patient, Male, NYSE, Safety, Roche, Generic drug, Pharmaceutical industry, EU

Reddy’s”), a global pharmaceutical company, announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase I study.

Key Points: 
  • Reddy’s”), a global pharmaceutical company, announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase I study.
  • This Phase I study used an intravenous (IV) formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of Dr. Reddy’s tocilizumab biosimilar candidate in comparison to reference products.
  • Pharmacokinetic equivalence of DRL_TC to the EU reference medicinal product* and the U.S. reference product** was successfully demonstrated.
  • Dr. Reddy’s is developing the proposed tocilizumab biosimilar as both intravenous and subcutaneous formulations.

CMS grants Fresenius Kabi permanent, product-specific Q-Code for Stimufend® (pegfilgrastim-fpgk)

Retrieved on: 
Tuesday, May 16, 2023
Health, FDA, Medical Devices, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Infection, Healthcare Common Procedure Coding System, Medicare, Incidence, Hematopoietic stem cell transplantation, HCPCS, Center for Medicare and Medicaid Innovation, CMS, Febrile neutropenia, Fresenius (company), Physician, Patient, Centers for Medicare & Medicaid Services, Pharmaceutical industry, Pegfilgrastim

Fresenius Kabi announced today that the Centers for Medicare and Medicaid Services (CMS) issued a permanent product-specific Q-code for Stimufend® (pegfilgrastim-fpgk).

Key Points: 
  • Fresenius Kabi announced today that the Centers for Medicare and Medicaid Services (CMS) issued a permanent product-specific Q-code for Stimufend® (pegfilgrastim-fpgk).
  • Under the Healthcare Common Procedure Coding System (HCPCS), the Q-code assigned to Stimufend is effective for patients administered Stimufend on and after April 1, 2023.
  • “Now physicians will be able to use a new permanent, product-specific Q-code for Stimufend,” said Ali Ahmed, senior vice president, Biosimilars, at Fresenius Kabi USA.
  • Limitations of Use: Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

BeyondSpring Provides Business Update and Reports Year End 2022 Financial Results

Retrieved on: 
Tuesday, April 18, 2023
Docetaxel, CIN, Pegfilgrastim, IIT, DIN, Radiation, ASH, Multiple myeloma, ESMO, NDA, Cancer, MSKCC, TPD, Oncology, Monroe Dunaway Anderson, NSCLC, Immunotherapy, Eli Lilly, ASCO, Congress, Patient, Investment, Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, Drug discovery, MM, Entrepreneurship, European Society for Medical Oncology, Therapy, Society, NMPA, Breast cancer, Pharmaceutical industry, Medical device, Cryptocurrency, Plinabulin, Pembrolizumab

NEW YORK, April 18, 2023 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on using its novel technology platform for drug discovery and development of innovative therapies to improve clinical outcomes for patients with high unmet medical needs, today provided a business update and reported results for the year ended December 31, 2022.

Key Points: 
  • In March 2023, BeyondSpring withdrew its NDA submission for the CIN indication from China’s National Medical Products Administration (NMPA) review.
  • The $17.7 million decrease was primarily due to lower pre-commercialization expenses for Plinabulin and lower personnel costs, as results of the organizational streamlining announced in January 2022.
  • Net loss attributable to the Company was $33.3 million for the year ended December 31, 2022, compared to $64.2 million for the year ended December 31, 2021.
  • As of December 31, 2022, the Company had cash, cash equivalents, and short-term investments of $37.3 million.

Samsung Bioepis Releases its First US Biosimilar Market Report, Providing Insights on Pricing Trends and Usage Across Molecules

Retrieved on: 
Monday, April 17, 2023
Epoetin alfa, Rituximab, Bevacizumab, ASP, Insulin, CMS, ASPS, Centers for Medicare & Medicaid Services, Biosimilar, Trastuzumab, Adalimumab, Insulin glargine, Market access, Samsung, Pegfilgrastim, Immunology, National Average Drug Acquisition Cost, WAC, Acquisition, Infliximab, Ophthalmology, Filgrastim, NADAC, Pharmaceutical industry, Generic drug

The first quarterly report details the most recent price trends of all molecules for which biosimilars have launched, along with insights into interchangeability of biosimilars.

Key Points: 
  • The first quarterly report details the most recent price trends of all molecules for which biosimilars have launched, along with insights into interchangeability of biosimilars.
  • “The first edition of Biosimilar Market Report from Samsung Bioepis reveals that market competition stimulated by the introduction of biosimilars in the US has contributed to significant price reductions in the biologics market.
  • However, the level of biosimilar usage varies by molecule, with some still taking less than 50% of the market share.
  • Insulin glargine and adalimumab categories reflect recent pricing practices such as unbranded biologics and high/low wholesale acquisition cost (WAC) options.

Coherus BioSciences Reports Fourth Quarter and Full Year 2022 Results

Retrieved on: 
Monday, March 6, 2023
PD-1, CMS, Centers for Medicare & Medicaid Services, Physician, COVID, Medicare, Conference call, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SG, Exercise, NPC, OBI, Biosimilar, GAAP, Patient, Risk, COGS, CHRS, Food, Nasopharyngeal carcinoma, Investment, Pegfilgrastim, Conference, FDA, R, Research, BLA, Dietary supplement, Medical device, Pharmaceutical industry, Cryptocurrency

REDWOOD CITY, Calif., March 06, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus” or the “Company”, Nasdaq: CHRS), today reported financial results for its fiscal fourth quarter and full year ended December 31, 2022 and recent business highlights:

Key Points: 
  • Coherus plans to launch UDENYCA® AI in the second quarter.
  • Coherus is introducing a guidance range of combined R&D and SG&A expenses for 2023 of $315 to $335 million.
  • This guidance reflects nearly $100 million in expense reductions compared to prior 2023 guidance provided in April 2022.
  • Beginning in the first quarter of 2022, the Company no longer regularly excludes upfront and milestone-based license fee payments from its non-GAAP financial information.