Biosimilar

Phase 3 Comparative Clinical Study of Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints

Retrieved on: 
Monday, April 8, 2024
Research, Women, Clinical Trials, Biotechnology, Managed Care, General Health, Pharmaceutical, Consumer, Health, Science, Name, Patient, Denosumab, BMD, Woman, Biosimilar, European, Fracture, Osteoporosis, Safety, Multimedia, OGN

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints.

Key Points: 
  • Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints.
  • In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14.
  • The agreement covers markets such as the United States, the European Union, and Canada.
  • The primary endpoints of this study were met.

Organon To Report First Quarter 2024 Results and Host Conference Call on May 2, 2024

Retrieved on: 
Monday, April 8, 2024
Biotechnology, Women, Consumer, Health, Pharmaceutical, GAAP, Denosumab, ID, Webcast, IPR, Uncertainty, Research, Biosimilar, EDT, OGN, Broadcasting

Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, will release its first quarter 2024 financial results on May 2, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Key Points: 
  • Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, will release its first quarter 2024 financial results on May 2, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.
  • Organon currently expects that it will record approximately $15 million of milestone payments in the first quarter of 2024, representing approximately $0.05 to both GAAP and non-GAAP earnings per share.
  • Organon’s first quarter 2024 results have not been finalized and are subject to the company’s quarterly financial statement closing procedures.
  • Accessing First Quarter 2024 Financial Results Webcast:
    Interested parties may access the live call via webcast on the Organon website at https://www.organon.com/investor-relations/events-and-presentations/ .

Alvotech Reports Financial Results for Full Year 2023 and Provides a Business Update

Retrieved on: 
Wednesday, March 20, 2024
Joint venture, Patient, Sale, Business analyst, CCHN, IP, Marketing, Research, Mallinckrodt, Absorption, European Economic Area, Gross metropolitan product, Webcast, Asset, Alvogen, Denosumab, Neovascularization, Biosimilar, Macular degeneration, Safety, Food, U.S. FDA, Teva Pharmaceuticals, Revenue, Q3, CES, AMD, FDA, ISK, Administration, Adalimumab, Research and development, Pharmaceutical industry

Management will conduct a business update conference all and live webcast on March 21, 2024 at 8:00 am ET (12:00 pm GMT).

Key Points: 
  • Management will conduct a business update conference all and live webcast on March 21, 2024 at 8:00 am ET (12:00 pm GMT).
  • Alvotech announced positive top-line results from a pharmacokinetic (PK) study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab).
  • Alvotech announced positive top-line results from a PK study for AVT03, a biosimilar candidate to Prolia® and Xgeva®, which both contain denosumab.
  • Alvotech will conduct a business update conference call and live webcast on Thursday, March 21, 2024, at 8:00 am ET (12:00 pm GMT).

Teva and mAbxience Announce Strategic Global Licensing Agreement for Oncology Biosimilar Candidate

Retrieved on: 
Thursday, April 4, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, TEVA, Partnership, Business, Patient, CGMP, Good manufacturing practice, Business development, Doctor of Philosophy, Biosimilar, Fresenius (company), Teva, Generic drug

Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced they have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications.

Key Points: 
  • Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced they have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications.
  • Biosimilars show promising potential in providing more cost-effective alternatives to existing oncology therapies, thereby addressing a critical need in global oncology care.
  • The licensing agreement covers multiple global markets, including in Europe and the United States, signaling a major step in mAbxience’s global expansion strategy, and supports a key element of Teva’s Pivot to Growth strategy, announced in 2023, to expand its biosimilar pipeline through business development and strategic partnerships.
  • Under the terms of the licensing agreement, mAbxience will leverage its expertise in biosimilar development and its state-of-the-art, current Good Manufacturing Practice (cGMP)-approved facilities in Spain and Argentina, to develop and produce the biosimilar product.

ELIQUENT Life Sciences Announces Appointment of Former FDA Senior Officials

Retrieved on: 
Thursday, March 21, 2024
Public Policy, Government, Biotechnology, Pharmaceutical, Health, FDA, Other Policy Issues, Medical Devices, College, Principal, Federation, Enzyme, Commissioner, Georgetown University, Regulatory affairs, BIO, National Cancer Institute, OBP, Biotechnology Innovation Organization, Laboratory, Quality, Divisional patent application, Biosimilar, Pennsylvania State University, Cell, Multimedia, Food, Pharmaceutical industry

ELIQUENT Life Sciences, a global regulatory consulting firm for the life sciences industry, today announced the appointment of John Taylor as head of the firm’s Quality & Compliance Practice and Michele Dougherty as head of the firm’s Regulatory Affairs Practice.

Key Points: 
  • ELIQUENT Life Sciences, a global regulatory consulting firm for the life sciences industry, today announced the appointment of John Taylor as head of the firm’s Quality & Compliance Practice and Michele Dougherty as head of the firm’s Regulatory Affairs Practice.
  • View the full release here: https://www.businesswire.com/news/home/20240321127987/en/
    John Taylor, Head of Quality & Compliance Practice, ELIQUENT Life Sciences (Photo: Business Wire)
    ELIQUENT’s integrated suite of services deliver the answers and solutions that global life sciences innovators need to gain and maintain market authorization for their products.
  • Most recently, John served for 10-years as President and Principal of Compliance & Regulatory Affairs at Greenleaf Health, a legacy brand of ELIQUENT Life Sciences.
  • A 10-year veteran of FDA, Michele’s career includes more than 15-years of regulatory experience across the product quality lifecycle, including her most recent role as President of DataRevive, a legacy brand of ELIQUENT Life Sciences.

AHF Urges Trinidad and Tobago to Sidestep Greedy GSK

Retrieved on: 
Friday, March 15, 2024
AIDS, Public Policy, Government, Health, Infectious Diseases, Advocacy Group Opinion, Pharmaceutical, ARV, GSK, HIV, COVID-19, AHF, Caribbean region of Colombia, Letter, AIDS Healthcare Foundation, Face, Biosimilar, Pharmaceutical industry

AIDS Healthcare Foundation (AHF) is calling on the government of Trinidad and Tobago to consider issuing a compulsory license for Tivicay (dolutegravir), a GSK antiretroviral (ARV) drug that treats HIV, which currently costs 25 times more than available biosimilar generics in neighboring Caribbean countries.

Key Points: 
  • AIDS Healthcare Foundation (AHF) is calling on the government of Trinidad and Tobago to consider issuing a compulsory license for Tivicay (dolutegravir), a GSK antiretroviral (ARV) drug that treats HIV, which currently costs 25 times more than available biosimilar generics in neighboring Caribbean countries.
  • In February, AHF and the Medical Research Foundation of Trinidad & Tobago sent a letter to GSK CEO Dame Emma Walmsley, which in part stated, “We urge you to address the lack of access to the antiretroviral drug Tivicay in Trinidad due to its high cost by lowering its price in line with biosimilar generics available in the Caribbean Region – or by committing not to threaten legal action against the purchase of a generic version of Tivicay.”
    To date, GSK has yet to respond to the letter.
  • Currently, Tivicay is under patent protection in Trinidad and Tobago, and GSK has threatened legal action if the country decides to import affordable generic ARVs.
  • “As a small island nation, Trinidad and Tobago is still recovering from the economic and social consequences of COVID-19 – paying 25 times more to provide lifelong HIV treatment for its people is untenable,” said AHF President Michael Weinstein.

EQS-News: FYB201/Ranibizumab keeps gaining momentum with approvals and launches in the MENA region

Retrieved on: 
Wednesday, March 13, 2024
Diabetes, Paratriathlon, Eye, Blood, Retina, Biosimilar, Gulf Cooperation Council, GCC, Ranibizumab, Prevalence, DR, Health, VEGF, Macular degeneration, Patient, NAMD, DME, CBO, Visual impairment, Partnership, Pharmaceutical industry

In addition, further market launches are planned in Algeria and other Gulf Cooperation Council (GCC) markets over the course of 2024.

Key Points: 
  • In addition, further market launches are planned in Algeria and other Gulf Cooperation Council (GCC) markets over the course of 2024.
  • This strategic collaboration aims to improve access to ophthalmic treatments in the MENA region.
  • Biosimilar and specialty medicines are integral to MS Pharma product portfolio and play a crucial role in advancing our growth objectives in the MENA region.
  • This approval supports the company's commitment to the Saudi market and its broader strategic initiatives within the kingdom."

Alvotech and Teva Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira®

Retrieved on: 
Saturday, February 24, 2024
Pharmacy, Ulcerative colitis, Psoriasis, Uveitis, Ankylosing spondylitis, TEVA, Marketing, FDA, Partnership, Food, Teva Pharmaceuticals, Volunteering, Biosimilar, IC, Safety, Juvenile idiopathic arthritis, Rheumatoid arthritis, Hidradenitis suppurativa, Patient, Prescription, Environment, Generic drug

Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.

Key Points: 
  • Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.
  • SIMLANDI is the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA, and will qualify for interchangeable exclusivity for the 40mg/0.4ml injection.
  • An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand name drugs.
  • Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization, which leverages Teva’s extensive experience and sales and marketing infrastructure.

Sandoz receives Health Canada approval for Jubbonti®, first and only denosumab biosimilar for treatment of osteoporosis

Retrieved on: 
Tuesday, February 20, 2024
Health Canada, Denosumab, RANK, Biosimilar, Safety, FRCPC, Novartis, Patient, Osteoporosis, Generic drug

Sandoz continues to expand access for patients in Canada, offering denosumab biosimilar to treat osteoporosis and increase bone mass.

Key Points: 
  • Sandoz continues to expand access for patients in Canada, offering denosumab biosimilar to treat osteoporosis and increase bone mass.
  • Health Canada approval based on robust Phase I and Phase III clinical studies.
  • BOUCHERVILLE, Quebec, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Sandoz Canada is pleased to announce that Health Canada has provided authorization to market Jubbonti® (denosumab subcutaneous injection, reference medicine: Prolia*).
  • Jubbonti® is the first and only Health Canada-approved denosumab biosimilar for osteoporosis and increasing bone mass.

Alvotech and Teva Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira®

Retrieved on: 
Saturday, February 24, 2024
Biotechnology, FDA, Health, Pharmaceutical, Managed Care, Pharmacy, Ulcerative colitis, Psoriasis, Uveitis, Ankylosing spondylitis, Multimedia, TEVA, Marketing, Teva, Partnership, Food, Teva Pharmaceuticals, Volunteering, Biosimilar, IC, Safety, Juvenile idiopathic arthritis, Rheumatoid arthritis, Hidradenitis suppurativa, Patient, Prescription, Environment, Generic drug

Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.

Key Points: 
  • Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.
  • An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand name drugs.
  • As the only interchangeable adalimumab biosimilar with the high-concentration formulation, SIMLANDI can be substituted for Humira at the pharmacy level, subject to state pharmacy laws.
  • Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization, which leverages Teva’s extensive experience and sales and marketing infrastructure.