Biosimilar

Frost & Sullivan Awarded Duopharma Biotech with the 2022 Malaysian Company of the Year Award

Retrieved on: 
Thursday, July 27, 2023
Anemia, Automotive Executive of the Year Award, Korea Muslim Federation, Diabetes, Health care, Policy, Cancer, KMF, Epoetin alfa, Oncology, Dialysis, Biotechnology, Frost, Hospital, Patient, Halal, SAN, Biosimilar, Generic drug, Pharmaceutical industry, ASEAN

SAN ANTONIO, July 27, 2023 /PRNewswire/ -- Frost & Sullivan recently researched the Malaysian biosimilars industry and, based on its findings, recognizes Duopharma Biotech Berhad (Duopharma Biotech) with the 2022 Malaysian Company of the Year Award. Duopharma Biotech delivers accessible and affordable healthcare to the Malaysian population by leveraging biosimilars, which are scientifically approved alternatives to drugs derived from biological sources.

Key Points: 
  • Duopharma Biotech is the first pharmaceutical company to offer biosimilar products in the Malaysian market.
  • SAN ANTONIO, July 27, 2023 /PRNewswire/ -- Frost & Sullivan recently researched the Malaysian biosimilars industry and, based on its findings, recognizes Duopharma Biotech Berhad (Duopharma Biotech) with the 2022 Malaysian Company of the Year Award .
  • Duopharma Biotech delivers accessible and affordable healthcare to the Malaysian population by leveraging biosimilars, which are scientifically approved alternatives to drugs derived from biological sources.
  • Each year, Frost & Sullivan presents a Company of the Year award to the organization demonstrating excellence in growth strategy and implementation in its field.

Frost & Sullivan Awarded Duopharma Biotech with the 2022 Malaysian Company of the Year Award

Retrieved on: 
Thursday, July 27, 2023
Anemia, Automotive Executive of the Year Award, Korea Muslim Federation, Diabetes, Health care, Policy, Cancer, KMF, Epoetin alfa, Oncology, Dialysis, Biotechnology, Frost, Hospital, Patient, Halal, SAN, Biosimilar, Generic drug, Pharmaceutical industry, ASEAN

SAN ANTONIO, July 27, 2023 /PRNewswire/ -- Frost & Sullivan recently researched the Malaysian biosimilars industry and, based on its findings, recognizes Duopharma Biotech Berhad (Duopharma Biotech) with the 2022 Malaysian Company of the Year Award. Duopharma Biotech delivers accessible and affordable healthcare to the Malaysian population by leveraging biosimilars, which are scientifically approved alternatives to drugs derived from biological sources.

Key Points: 
  • Duopharma Biotech is the first pharmaceutical company to offer biosimilar products in the Malaysian market.
  • SAN ANTONIO, July 27, 2023 /PRNewswire/ -- Frost & Sullivan recently researched the Malaysian biosimilars industry and, based on its findings, recognizes Duopharma Biotech Berhad (Duopharma Biotech) with the 2022 Malaysian Company of the Year Award .
  • Duopharma Biotech delivers accessible and affordable healthcare to the Malaysian population by leveraging biosimilars, which are scientifically approved alternatives to drugs derived from biological sources.
  • Each year, Frost & Sullivan presents a Company of the Year award to the organization demonstrating excellence in growth strategy and implementation in its field.

Protein Expression Market to be Worth $6.64 Billion by 2030: Grand View Research, Inc.

Retrieved on: 
Tuesday, July 25, 2023
Acceleration, United States at the 2022 World Games, Amgen, Food, Australian government debt, MRFF, Drink, COVID-19, Gene, Prokaryote, Proteomics, Research, Genomics, Biomarker, Multiple sclerosis, USD, Government, MS, Medical Research Future Fund, Incidence, Protein, Investment, Patient, SAN, Conditional sentence, Growth, Biosimilar, R, A-DNA, ChromeOS, Reagent, Fine chemical, Pharmaceutical industry

Key Industry Insights & Findings from the report:

Key Points: 
  • Key Industry Insights & Findings from the report:
    By expression system, the prokaryotic segment accounted for the largest share in 2022.
  • Read 150 page market research report, " Protein Expression Market Size, Share & Trends Analysis Report By Expression System (Prokaryotic, Mammalian Cell), By Product (Reagents, Competent Cells), By Application (Therapeutic, Industrial), By End-use, And Segment Forecasts, 2023 - 2030 ", published by Grand View Research.
  • An increase in R&D investments by the players is estimated to have a considerable impact on the usage of protein expression.
  • Other determinants such as rapid acceleration in the demand for protein therapeutics and government investment in the applications of the protein expression industry are also supporting the market growth.

Teva Pharmaceuticals and Alvotech Provide Update on Strategic Biosimilars Partnership

Retrieved on: 
Monday, July 24, 2023
Partnership, TEVA, Teva, Food and Drug Administration, Adalimumab, TEL, Patient, TASE, Biosimilar, FDA, Ustekinumab, NYSE, Food, Eastern Coast of Central America Commercial and Agricultural Company, Generic drug

Teva will also acquire subordinated convertible bonds to be issued by Alvotech.

Key Points: 
  • Teva will also acquire subordinated convertible bonds to be issued by Alvotech.
  • The expansion to the existing strategic partnership agreement pertains to exclusive commercialization in the U.S. by Teva of two new biosimilar candidates and line extensions of two current biosimilar candidates in the partnership, to be developed, and manufactured by Alvotech.
  • Teva and Alvotech will share profit from the commercialization of the biosimilars.
  • “We welcome Teva’s continued partnership and this expansion of our partnership agreement,” said Robert Wessman, Chairman and CEO of Alvotech.

Teva Pharmaceuticals and Alvotech Provide Update on Strategic Biosimilars Partnership

Retrieved on: 
Monday, July 24, 2023
Health, FDA, Other Health, General Health, Pharmaceutical, Biotechnology, Partnership, TEVA, Teva, Food and Drug Administration, Adalimumab, Medication, Patient, TASE, Biosimilar, Ustekinumab, NYSE, Food, Eastern Coast of Central America Commercial and Agricultural Company, Generic drug

Teva will also acquire subordinated convertible bonds to be issued by Alvotech.

Key Points: 
  • Teva will also acquire subordinated convertible bonds to be issued by Alvotech.
  • The expansion to the existing strategic partnership agreement pertains to exclusive commercialization in the U.S. by Teva of two new biosimilar candidates and line extensions of two current biosimilar candidates in the partnership, to be developed, and manufactured by Alvotech.
  • Teva and Alvotech will share profit from the commercialization of the biosimilars.
  • “We welcome Teva’s continued partnership and this expansion of our partnership agreement,” said Robert Wessman, Chairman and CEO of Alvotech.

Dr. Reddy’s Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA

Retrieved on: 
Wednesday, July 12, 2023
FDA, Pharmaceutical, Health, Clinical Trials, China Biologic Products, BSE, Rituximab, EU, Fresenius (company), Vasculitis, File, Chronic lymphocytic leukemia, Marketing, CD20, Health care, European Medicines Agency, USFDA, Pharmacokinetics, RDY, Rheumatoid arthritis, Microscopic polyangiitis, EMA, NSE, B-cell lymphoma, Patient, Granuloma, Medicines and Healthcare products Regulatory Agency, Biosimilar, United, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, BLA, NYSE, Food, MHRA, Generic drug

Reddy’s”), a global pharmaceutical company, announced that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration (USFDA).

Key Points: 
  • Reddy’s”), a global pharmaceutical company, announced that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration (USFDA).
  • This closely follows acceptance of its rituximab biosimilar dossier for review by two other regulatory agencies – the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).
  • DRL_RI is being developed as a biosimilar of Rituxan® / MabThera® (rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody.
  • generic drugs for critical and chronic conditions, to commercialise its proposed biosimilar of rituximab in the United States.

Celltrion USA Launches Yuflyma® (adalimumab-aaty), a Humira® (adalimumab) biosimilar, in the United States

Retrieved on: 
Monday, July 3, 2023
Oncology, FDA, Health, Clinical Trials, General Health, Biotechnology, AIDS Drug Assistance Programs, University of Massachusetts, Ankylosing spondylitis, Nursing, Ulcerative colitis, Psoriasis, Juvenile idiopathic arthritis, Food and Drug Administration Amendments Act of 2007, Patient, PAP, Biosimilar, Celltrion, Food, Rheumatoid arthritis, Pharmaceutical industry, Adalimumab

Celltrion USA today announced the launch of Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar, providing an alternative option for patients.

Key Points: 
  • Celltrion USA today announced the launch of Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar, providing an alternative option for patients.
  • “We are committed to providing a patient-centric approach with a focus on increased access to innovative, high-quality biologics in the United States.
  • Patients who are uninsured or underinsured may be eligible to receive Yuflyma through the Celltrion CONNECT® Patient Assistance Program (PAP).
  • Celltrion is seeking an interchangeability designation from the U.S. FDA for Yuflyma, tentatively expected Q4 in 2024.

EQS-News: Formycon announces submission of the biologics license application (BLA) for FYB203, an aflibercept biosimilar candidate to the U.S. Food and Drug Administration (FDA)

Retrieved on: 
Thursday, June 29, 2023
Retina, Klinge, Blood, Regeneron Pharmaceuticals, Ophthalmology, ISIN, Biosimilar, Ranibizumab, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Generic drug, Pharmaceutical industry

Formycon announces submission of the biologics license application (BLA) for FYB203, an aflibercept biosimilar candidate to the U.S. Food and Drug Administration (FDA)

Key Points: 
  • Formycon announces submission of the biologics license application (BLA) for FYB203, an aflibercept biosimilar candidate to the U.S. Food and Drug Administration (FDA)
    The issuer is solely responsible for the content of this announcement.
  • Press Release // June 29, 2023
    Formycon announces submission of the biologics license application (BLA) for FYB203, an aflibercept biosimilar candidate to the U.S. Food and Drug Administration (FDA)
    Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge“) announce that the biologics license application (BLA) for FYB203, a biosimilar candidate for Eylea®1 (Active ingredient: Aflibercept) has been submitted to the U.S. Food and Drug Administration („FDA“) in line with the initial schedule.
  • Within 60 days after submission, FDA is expected to decide on whether to accept and to further review the BLA (“file acceptance”).
  • “We are very delighted to bring our second biosimilar candidate in ophthalmology on formal track for approval in the U.S.

Alvotech Provides Regulatory Update on Second Biologics License Application for AVT02

Retrieved on: 
Thursday, June 29, 2023
Communication, US Foods, Blas, Adalimumab, Sale, Patient, CRL, Biosimilar, FDA, BLA, Generic drug

As the second of two BLAs submitted for AVT02, this BLA contained data to support approval as a high-concentration biosimilar and additional information to support the interchangeability designation.

Key Points: 
  • As the second of two BLAs submitted for AVT02, this BLA contained data to support approval as a high-concentration biosimilar and additional information to support the interchangeability designation.
  • No other deficiencies in the application were noted by the FDA.
  • In addition to AVT02, the company is currently developing a pipeline of 7 disclosed and 3 undisclosed biosimilar candidates.
  • “We expect that a reinspection of our manufacturing facility will be required to gain approval in the US and anticipate a reinspection following resubmission of a BLA for AVT02.”

National Alliance of Healthcare Purchaser Coalitions Releases Call to Action for Employers to Address Conflicts in the PBM Industry

Retrieved on: 
Monday, June 26, 2023
National Alliance, Human resources, National Alliance on Mental Illness, Negotiation, Pharmacy, The National Alliance, Consultant, Ensure, PBM, Evaluation, Poultry, Biosimilar, Playbook, Employment, Health insurance, Management, Financial adviser, Dietary supplement, Pharmaceutical industry

WASHINGTON, June 26, 2023 /PRNewswire/ -- High prescription drug costs continue to bankrupt families, put financial strain on businesses, and drag down the US economy and pharmacy benefit management plays a significant behind-the-scenes role. To arm employers and other plan sponsors with a blueprint to understand and navigate PBM relationships and strengthen their negotiating and contracting capabilities, the National Alliance of Healthcare Purchaser Coalitions (National Alliance) developed A Playbook for Employers – Addressing Pharmacy Benefit Management Misalignment.

Key Points: 
  • To arm employers and other plan sponsors with a blueprint to understand and navigate PBM relationships and strengthen their negotiating and contracting capabilities, the National Alliance of Healthcare Purchaser Coalitions (National Alliance) developed A Playbook for Employers – Addressing Pharmacy Benefit Management Misalignment .
  • "As fiduciaries, employers have a responsibility to challenge industry misalignment and self-dealing, and this playbook offers strategies to contract for and build a more trustworthy, responsible and sustainable marketplace," said Michael Thompson, National Alliance president and CEO.
  • The top 10 pharmacy benefit management concerns identified by an industry advisory committee and purchasers working with the National Alliance for this initiative are:
    Promotion of higher-price drugs when lower-price drugs are available.
  • Own the relationship – Take control across the spectrum of claims data, audit rights, contract development and formulary management.