Biosimilar

Growth Opportunities in Biosimilars Market - Global Forecast to 2028: Leveraging AI, PD, and Omics Biomarkers with Focus on the Middle East and Africa - ResearchAndMarkets.com

Retrieved on: 
Monday, December 18, 2023
Biotechnology, Health, Pharmaceutical, Technology, Artificial Intelligence, Biosimilar, Patient, Safety, Element, Patent, Neurology, Environment, Generic drug

The "Growth Opportunities in Global Biosimilars Market, Forecast to 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Growth Opportunities in Global Biosimilars Market, Forecast to 2028" report has been added to ResearchAndMarkets.com's offering.
  • This study presents overall market and segment-wise revenue forecasts for the global biosimilars market.
  • It highlights key growth opportunities for biosimilar market participants based on the trends, evolution of business models, and strategic imperatives for various stakeholders.
  • This report identifies key growth opportunities to increase biosimilar uptake and innovations and compete for newer therapy areas, such as neurology and oncology.

Alvotech and JAMP Pharma Announce Receipt of Marketing Authorization for Jamteki™ (AVT04), the First Biosimilar of Stelara® (ustekinumab)

Retrieved on: 
Tuesday, November 14, 2023
Health Canada, Ustekinumab, Patient, Marketing, Caregiver, Biosimilar, Partnership, Adalimumab, Generic drug, Greater Montreal

REYKJAVIK, Iceland and BOUCHERVILLE, Quebec, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and JAMP Pharma Group (“JAMP Pharma”), a Canadian owned pharmaceutical organization headquartered in the Greater Montreal area, announced today that Health Canada has granted JAMP Pharma marketing authorization for AVT04, a biosimilar to Stelara® (ustekinumab) developed by Alvotech. AVT04 will be marketed under the brand name JamtekiTM.

Key Points: 
  • PrJamtekiTM is the second biosimilar developed under this partnership that receives marketing authorization in Canada.
  • REYKJAVIK, Iceland and BOUCHERVILLE, Quebec, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and JAMP Pharma Group (“JAMP Pharma”), a Canadian owned pharmaceutical organization headquartered in the Greater Montreal area, announced today that Health Canada has granted JAMP Pharma marketing authorization for AVT04, a biosimilar to Stelara® (ustekinumab) developed by Alvotech.
  • This is the second biosimilar to receive marketing authorization, developed under an exclusive commercialization partnership between Alvotech and JAMP Pharma.
  • JAMP Pharma and Alvotech announced their exclusive partnership for the commercialization of biosimilars in Canada in January 2022 then expanded the agreement in October 2022.

STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara

Retrieved on: 
Friday, November 10, 2023
Cytokine, European Economic Area, Safety, Dermatology, Perfusion, Psoriasis, EMA, Patient, Biosimilar, CHMP, Rheumatology, Psoriatic arthritis, Gastroenterology, Partnership, Adalimumab, Generic drug, Pharmaceutical industry, Vaccine, Ustekinumab

Under a strategic partnership begun in 2019, Alvotech is primarily responsible for developing and manufacturing the AVT04 ustekinumab biosimilar.

Key Points: 
  • Under a strategic partnership begun in 2019, Alvotech is primarily responsible for developing and manufacturing the AVT04 ustekinumab biosimilar.
  • STADA holds commercial rights within Europe, where the company already markets six approved biosimilars, including in gastrointestinal, dermatology and rheumatology indications.
  • STADA’s Global Specialty Head, Bryan Kim, commented: “This positive CHMP opinion puts STADA and Alvotech in prime position to improve patient access in the ustekinumab and interleukin inhibitor markets.
  • AVT04 was designed using the Sp2/0 host cell line and is manufactured using a perfusion process, like the reference product Stelara.

FDA Approves Bio-Thera Solutions' Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin®

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Thursday, December 7, 2023
USFDA, Lung, Safety, Patient, FDA, Lung cancer, Pharmacokinetics, Novartis, Biosimilar, Generic drug, Bevacizumab

Avzivi® is Bio-Thera's second USFDA approved product and is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States.

Key Points: 
  • Avzivi® is Bio-Thera's second USFDA approved product and is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States.
  • The FDA approval of Avzivi® was based on a comprehensive analytical, non-clinical and clinical data package submitted by Bio-Thera to the FDA.
  • Extensive analytical characterization between BAT1706 and US and EU Avastin® was conducted on structural, physicochemical, and biological properties to support biosimilarity of BAT1706.
  • The approval of Avzivi® by the FDA will provide lung and colorectal cancer patients a new cost-effective treatment option.

Alvotech and JAMP Pharma announce receipt of marketing authorization for PrJamtekiTM (AVT04), the first biosimilar of Stelara® (ustekinumab)

Retrieved on: 
Tuesday, November 14, 2023
Health Canada, Ustekinumab, Patient, Marketing, Caregiver, Biosimilar, Partnership, Adalimumab, Generic drug, QC, Greater Montreal

PrJamtekiTM is the second biosimilar developed under this partnership that receives marketing authorization in Canada.

Key Points: 
  • PrJamtekiTM is the second biosimilar developed under this partnership that receives marketing authorization in Canada.
  • This is the second biosimilar to receive marketing authorization, developed under an exclusive commercialization partnership between Alvotech and JAMP Pharma.
  • "We are very pleased to receive marketing authorization for our second biosimilar in Canada with JAMP Pharma," said Robert Wessman, Chairman and CEO of Alvotech.
  • JAMP Pharma and Alvotech announced their exclusive partnership for the commercialization of biosimilars in Canada in January 2022 then expanded the agreement in October 2022.

EQS-News: Formycon publishes nine-month results for 2023

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Thursday, December 14, 2023
Investment, EMA, Fresenius (company), PIN, Ranibizumab, Marketing, European Medicines Agency, FDA, Food, Pembrolizumab, Tax, Depreciation, CFO, Biosimilar, Ustekinumab, EBITDA, Development, CET, Genentech, Partnership, ISIN, Video game, Cryptocurrency, Pharmaceutical industry, Generic drug, Fine chemical, Kerosene

Preparations for the start of the clinical development program for the biosimilar candidate FYB206 (pembrolizumab) are already well advanced.

Key Points: 
  • Preparations for the start of the clinical development program for the biosimilar candidate FYB206 (pembrolizumab) are already well advanced.
  • As expected, the Formycon Group's cash and cash equivalents amounted to around € 35.6 million as of September 30, 2023, compared to € 9.8 million as of December 31, 2022.
  • The conference call, which will be streamed live online, will be held in English on November 13, 2023 at 3:00 p.m. (CET).
  • The conference call will be recorded and will be available afterwards via the Formycon website at: https://www.formycon.com/investoren/fakten-zahlen/ .

Rani Therapeutics Reports Third Quarter 2023 Financial Results; Provides Corporate Update

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Wednesday, November 8, 2023
Female, Research, Growth, Clinical trial, Longest increasing subsequence, Workforce, Volunteering, Biosimilar, Society, American Society for Bone and Mineral Research, Interleukin, Expansion, Antibody, GLP, HC, Business, Animal, Osteoporosis, Serum, Ustekinumab, Safety, Therapy, Teriparatide, SAN, Risk management, Medical imaging, Dietary supplement, Pharmaceutical industry, Birth control, Vaccine, Cryptocurrency, Adalimumab

In October 2023, Rani announced preclinical data from a 60-day, repeat oral-administration GLP safety study of the RaniPill capsule in healthy animals.

Key Points: 
  • In October 2023, Rani announced preclinical data from a 60-day, repeat oral-administration GLP safety study of the RaniPill capsule in healthy animals.
  • Presented an Abstract on RT-102 at the 2023 Annual Meeting of the American Society for Bone and Mineral Research.
  • Rani has completed two preclinical studies of the RaniPill HC with antibodies, adalimumab and an undisclosed interleukin (“Interleukin”).
  • Initiation of Phase 2 clinical trial of RT-102, a RaniPill GO containing teriparatide for osteoporosis, expected by year-end 2023.

FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases

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Tuesday, October 31, 2023
Abdominal pain, FDA, Research, Psoriasis, Headache, Biosimilar, Inflammation, Food, Itch, Vomiting, Center for Drug Evaluation and Research, Upper respiratory tract infection, Diarrhea, Bronchitis, Light, Infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Posterior reversible encephalopathy syndrome, Ulcerative colitis, Nausea, Fever, Crohn's disease, Disease, Risk, Pharmacy, Malignancy, Medication, Urinary tract infection, China Biologic Products, Safety, Hospital, Immunology, Patient, Sinusitis, Fatigue, Pharmaceutical industry, Vaccine, Generic drug, Ustekinumab, Common

SILVER SPRING, Md., Oct. 31, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.

Key Points: 
  • SILVER SPRING, Md., Oct. 31, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.
  • An interchangeable biosimilar is a biosimilar that has been shown to meet other requirements under the law and may be substituted for the reference product without consulting the prescriber.
  • This means health care providers and patients can expect the same safety and effectiveness from both a biosimilar and an interchangeable biosimilar, just as they would for a reference product.
  • Biosimilar and interchangeable biosimilar products may cost less than the brand-name medicine.

Celltrion USA announces distribution and incorporation of YUFLYMA® (adalimumab-aaty), a Humira® biosimilar, to CarePartners Specialty Pharmacy Cost Savings Programs

Retrieved on: 
Thursday, October 26, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical Trials, Food, Pharmacist, Celltrion, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Light, Biosimilar, Patient, Generic drug, Pharmaceutical industry, Adalimumab

Celltrion USA, Inc. (Celltrion USA) today announced its FDA-approved biosimilar, YUFLYMA® (adalimumab-aaty), has been added to CarePartners Specialty Pharmacy Cost Savings Programs.

Key Points: 
  • Celltrion USA, Inc. (Celltrion USA) today announced its FDA-approved biosimilar, YUFLYMA® (adalimumab-aaty), has been added to CarePartners Specialty Pharmacy Cost Savings Programs.
  • YUFLYMA is a high-concentration (100mg/mL) and citrate-free formulation of the Humira® (adalimumab) biosimilar.
  • CarePartners and its strategic partners will offer and distribute YUFLYMA as the lowest net cost high-concentration Humira (adalimumab) biosimilar to over 10 million plan members.
  • “Partnering with Celltrion to offer YUFLYMA solidifies our cost saving initiatives for plan sponsors, employers, health plans, and other payers.

Samsung Bioepis Presents Phase 1 and 3 Clinical Results for SB16, a Proposed Biosimilar to Proliaⁱ (denosumab), at ASBMR 2023

Retrieved on: 
Monday, October 16, 2023
Annual general meeting, Male, Interval (mathematics), BMD, Abstract, Trial of the century, AUC, Society, PK, Safety, American Society for Bone and Mineral Research, SB16, Month, Biosimilar, PMO, PD, EU, Cis, Patient, Generic drug, Denosumab

The primary PK endpoints were area under the concentration-time curve (AUC) from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum serum concentration.

Key Points: 
  • The primary PK endpoints were area under the concentration-time curve (AUC) from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum serum concentration.
  • “We are pleased to present clinical data for SB16 for the first time at the ASBMR Annual Meeting.
  • Through Phase 1 and 3 clinical studies, SB16 demonstrated biosimilarity to reference denosumab, meeting all the primary endpoints in both studies,” said Ilsun Hong, Vice President and Product Evaluation Team Leader at Samsung Bioepis.
  • The details of the SB16 abstracts presented at ASBMR 2023 Annual Meeting are as below: