Biosimilar

Harrow Licenses Canadian Rights to Apotex for Five Branded Ophthalmic Pharmaceutical Products

Retrieved on: 
Thursday, February 15, 2024
Surgery, Medical Supplies, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Optical, Senior, OTC, Telecanthus, Alkane, Allergic conjunctivitis, VKC, Patient, Biosimilar, Vernal keratoconjunctivitis, Partnership

Harrow, Inc. (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, and Apotex Inc. (“Apotex”), Canada’s largest pharmaceutical company, today jointly announced an exclusive out-licensing agreement under which Apotex will market and distribute VERKAZIA® and over-the-counter (OTC) Cationorm® PLUS in the Canadian market, and concurrently, pursue market approval in Canada for VEVYE®, IHEEZO®, and ZERVIATE®.

Key Points: 
  • Harrow, Inc. (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, and Apotex Inc. (“Apotex”), Canada’s largest pharmaceutical company, today jointly announced an exclusive out-licensing agreement under which Apotex will market and distribute VERKAZIA® and over-the-counter (OTC) Cationorm® PLUS in the Canadian market, and concurrently, pursue market approval in Canada for VEVYE®, IHEEZO®, and ZERVIATE®.
  • View the full release here: https://www.businesswire.com/news/home/20240215859659/en/
    “We are pleased to enter the Canadian market through this partnership with Apotex, which has a proven track record of success serving Canadian eyecare professionals and their patients,” said Mark L. Baum, Chairman and Chief Executive Officer of Harrow.
  • And for products, Apotex will pursue approval for in Canada:
    VEVYE (cyclosporine ophthalmic solution) 0.1%, a novel water-free vehicle (perfluorobutylpentane) based on semifluorinated alkanes, indicated to treat the signs and symptoms of dry eye disease.
  • ZERVIATE (cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated for the treatment of ocular itching associated with allergic conjunctivitis.

Alvotech Announces Expected Global Market Entry Dates for AVT04 Biosimilar to Stelara® (ustekinumab)

Retrieved on: 
Thursday, February 15, 2024
National health insurance, Food, Johnson & Johnson, European Economic Area, Biosimilar, Patient, EEA, Stada Arzneimittel, SPC

Market applications for AVT04 are currently pending in additional global markets, including in the U.S.

Key Points: 
  • Market applications for AVT04 are currently pending in additional global markets, including in the U.S.
    Market entry of AVT04 in Canada is expected in Q1 2024.
  • Market authorization for AVT04 in Japan is held by Alvotech’s commercial partner Fuji Pharma Co. Ltd., where the biosimilar will be marketed as Ustekinumab BS (F).
  • Alvotech’s commercial partner and market authorization holder for AVT04 in Canada is JAMP Pharma Group, where the biosimilar will be marketed as Jamteki®.
  • In the EEA, Alvotech’s commercial partner and market authorization holder for AVT04 is STADA Arzneimittel AG, where the trade name for AVT04 will be Uzpruvo®.

Rani Therapeutics Announces Positive Topline Results from Phase 1 Study of an Oral Anti-Interleukin 12/23 Antibody (RT-111)

Retrieved on: 
Monday, February 5, 2024
Pharmacokinetics, Peptide, Cytokine, Human, Trial of the century, Patient, Safety, Psoriasis, Interleukin, Ustekinumab, Biosimilar, Volunteering, Ulcerative colitis, Vaccine

ET / 5:30 a.m. PT –

Key Points: 
  • ET / 5:30 a.m. PT –
    SAN JOSE, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced positive topline results from its Phase 1 clinical study of RT-111, a RaniPill® capsule containing an ustekinumab biosimilar, CT-P43.
  • In the study, RT-111 was well-tolerated and delivered ustekinumab with high bioavailability.
  • “We are highly encouraged by the positive results from our Phase 1 study for RT-111 – our third successfully completed Phase 1 trial using RaniPill® technology.
  • To our knowledge, RT-111 is the first ever oral monoclonal antibody to achieve high bioavailability in humans,” said Talat Imran, Chief Executive Officer of Rani.

Teva Announces Intention to Divest API Business as Part of Pivot to Growth Strategy

Retrieved on: 
Wednesday, January 31, 2024
Biotechnology, Health, Science, Pharmaceutical, Research, Growth, Patient, Pivot, Medication, Annual report, TEVA, API, Biosimilar, Fine chemical

Teva announced today its intention to divest its active-pharmaceutical ingredient (API) business, or "TAPI".

Key Points: 
  • Teva announced today its intention to divest its active-pharmaceutical ingredient (API) business, or "TAPI".
  • TAPI is a global leader in the small-molecule API industry, with approximately 4,300 employees worldwide.
  • The intent to divest “TAPI” will allow Teva to maximize current and potential revenue streams, focusing on capital reallocation towards growth and innovation, and to better serve patients.
  • It will also allow the divested company to pursue new growth strategies, enabling it to maximize an array of opportunities in the $85 billion global API market.

Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva®

Retrieved on: 
Monday, January 29, 2024
Woman, Denosumab, Patient, Biosimilar, Risk, Osteoporosis, Safety, Fracture, Pharmacokinetics, Dietary supplement

The PK study ( AVT03-GL-P01 ), which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints.

Key Points: 
  • The PK study ( AVT03-GL-P01 ), which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints.
  • A confirmatory efficacy study for AVT03 in patients is currently underway, as well as a PK study comparing AVT03 to Xgeva® in healthy adult subjects.
  • This milestone, and recent positive top-line results from other clinical studies clearly demonstrate our capabilities and the excellence of Alvotech’s biosimilars development platform,” said Joseph McClellan, Chief Scientific Officer.
  • Prolia (denosumab) is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture.

NeoImmuneTech Welcomes a New President for its Development and Business

Retrieved on: 
Monday, January 15, 2024
Senior, Research, Human Genome Sciences, Biosimilar, NIT, Pharmacology, McGill University, Division, Drug development, Inflammation, Acute radiation syndrome, Organization, Doctor of Philosophy, IL-7, ARS, Mallinckrodt, Vertex Pharmaceuticals, Pharmaceutical industry

ROCKVILLE, Md., Jan. 15, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, today announces the appointment of Luke Oh, Ph.D., as President, effective immediately.

Key Points: 
  • ROCKVILLE, Md., Jan. 15, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, today announces the appointment of Luke Oh, Ph.D., as President, effective immediately.
  • Dr. Oh is an expert in regulatory policies and drug development, encompassing both biologics and small molecules.
  • Se Hwan Yang, Ph.D., Chief Executive Officer of NeoImmuneTech, Inc. said: "We are delighted to welcome Dr. Oh to our team.
  • His strong expertise and extensive network are invaluable assets that will propel our clinical development program and business activities.

STADA and Alvotech secure approval for Uzpruvo, Europe’s first ustekinumab biosimilar to Stelara

Retrieved on: 
Wednesday, January 10, 2024
Psoriatic arthritis, Dermatology, Patient, CHMP, BAD, Cytokine, Partnership, Ustekinumab, Rheumatology, Civil service commission, Biosimilar, European Commission, Adalimumab, Partner, EMA, Psoriasis, Safety, SPC, Committee, Marketing, Gastroenterology, Pharmaceutical industry

Biosimilar competition in the €2.5 billion (US$2.7 billion) EU ustekinumab market could significantly expand patient access to this life-changing biologic therapy within gastroenterology, dermatology, and rheumatology.

Key Points: 
  • Biosimilar competition in the €2.5 billion (US$2.7 billion) EU ustekinumab market could significantly expand patient access to this life-changing biologic therapy within gastroenterology, dermatology, and rheumatology.
  • STADA’s Global Specialty Head, Bryan Kim, commented: “This first marketing authorization for biosimilar ustekinumab in Europe offers the potential to expand substantially patient access through competition.
  • Under a strategic partnership begun in 2019, Alvotech is primarily responsible for developing and manufacturing the AVT04 ustekinumab biosimilar.
  • These include a high-concentration, citrate-free adalimumab biosimilar developed and marketed through the partnership between Alvotech and STADA.

Celltrion presents strategic vision and growth plan at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Thursday, January 11, 2024
Celltrion, Patient, Health, Intelligence, Biosimilar, PHS, Infliximab, Conference, Drug development, FDA, Pharmaceutical industry

Celltrion's Chairman Jung-Jin Seo and CEO Jin-Seok Seo discussed the company's strategic priorities and progress, including the company's vision to move beyond biosimilars through the 2024 launch of ZYMFENTRA™ in the U.S. and expansion into digital healthcare.

Key Points: 
  • Celltrion's Chairman Jung-Jin Seo and CEO Jin-Seok Seo discussed the company's strategic priorities and progress, including the company's vision to move beyond biosimilars through the 2024 launch of ZYMFENTRA™ in the U.S. and expansion into digital healthcare.
  • He also shared insights and trends on the biosimilar industry and how the market landscape is impacting Celltrion's strategy.
  • Jin-Seok Seo said, ''Celltrion has the potential to grow its revenue by at least fivefold in 2030, once our 22-drug portfolio is commercialized.
  • Celltrion remains committed to pursuing its goal in promoting the health and well-being of patients."

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

EQS-News: Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration

Retrieved on: 
Saturday, December 30, 2023
Fresenius (company), Food, EMA, FDA, Biologics license application, Ulcerative colitis, Press release, Ustekinumab, Patient, Psoriasis, Biosimilar, BLA, Generic drug

Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration

Key Points: 
  • Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration
    The issuer is solely responsible for the content of this announcement.
  • Press Release // November 30, 2023
    Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration
    Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its commercialization partner Fresenius Kabi today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the Biologics License Application (“BLA”) for FYB202, a proposed biosimilar candidate to Stelara®1.
  • FYB202 is a human monoclonal antibody that targets interleukin 12 and interleukin 23 for the treatment of immune-mediated disorders.
  • “The FDA file acceptance for our Stelara® biosimilar candidate FYB202 underlines the great expertise and capabilities of #TeamFormycon.