Biosimilar

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.

Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®

Retrieved on: 
Wednesday, November 29, 2023
Rheumatoid arthritis, Pharmacokinetics, Patient, Safety, Trial of the century, Biosimilar, Generic drug

REYKJAVIK, Iceland, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab).

Key Points: 
  • REYKJAVIK, Iceland, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab).
  • The study, which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi in healthy adult subjects, met its primary endpoints.
  • In the last twelve months up to October 2023, combined worldwide revenues from sales of Simponi and Simponi Aria were nearly $2.2 billion [1].
  • Alvotech’s current portfolio of 11 products and product candidates includes one launched product, one approved biosimilar and four biosimilar candidates in clinical studies, including AVT05.

Alvotech Reports Financial Results for First Nine Months of 2023 and Provides a Business Update

Retrieved on: 
Tuesday, November 28, 2023
Omalizumab, European Economic Area, European Commission, Partnership, Food, Johnson & Johnson, Food and Drug Administration, BLA, Business analyst, FDA, EMA, Marketing, Absorption, Research, Civil service commission, European Medicines Agency, Gross metropolitan product, Committee, Patient, Safety, Stada Arzneimittel, Webcast, G&A, Biosimilar, CHMP, Pharmaceutical industry

Alvotech and JAMP Pharma also announced the receipt of a marketing authorization in Canada for AVT04.

Key Points: 
  • Alvotech and JAMP Pharma also announced the receipt of a marketing authorization in Canada for AVT04.
  • Product Revenue: Product revenue was $29.8 million for the nine months ended September 30, 2023, compared to $11.1 million for the same nine months of 2022.
  • Income tax benefit: Income tax benefit was $67.1 million for the nine months ended September 30, 2023, compared to $14.8 million for the same nine months of 2022.
  • Alvotech will conduct a business update conference call and live webcast on Wednesday, November 29 at 8:00 am ET (13:00 GMT).

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®

Retrieved on: 
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

Retrieved on: 
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

Retrieved on: 
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.