- The study, assessing pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® (golimumab) in healthy adult subjects, met its primary endpoint
November 29, 2023 I 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.
“These results demonstrate the strength of our platform approach to biosimilars development and manufacture, combining a well-designed and executed clinical study with the design of a high-quality manufacturing process and strong analytical capabilities,” said Joseph McClellan, Chief Scientific Officer. “As we progress more biosimilar candidates through clinical development and approval, we continue to reaffirm our commitment to improving patient lives by expanding access to affordable biologics.”
In May 2023, Alvotech announced the initiation of a clinical study to compare the efficacy, safety, and immunogenicity of AVT05 and Simponi® in adult patients with moderate to severe rheumatoid arthritis.
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.
About AVT05
AVT05 is a biosimilar candidate for Simponi® and Simponi Aria® (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha. Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [2]. AVT05 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
[1] Based on quarterly filings from Johnson & Johnson
[2] https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI-pi.pdf
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
SOURCE: Alvotech
Post Views: 233
- The study, assessing pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® (golimumab) in healthy adult subjects, met its primary endpoint
November 29, 2023 I 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.
“These results demonstrate the strength of our platform approach to biosimilars development and manufacture, combining a well-designed and executed clinical study with the design of a high-quality manufacturing process and strong analytical capabilities,” said Joseph McClellan, Chief Scientific Officer. “As we progress more biosimilar candidates through clinical development and approval, we continue to reaffirm our commitment to improving patient lives by expanding access to affordable biologics.”
In May 2023, Alvotech announced the initiation of a clinical study to compare the efficacy, safety, and immunogenicity of AVT05 and Simponi® in adult patients with moderate to severe rheumatoid arthritis.
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.
About AVT05
AVT05 is a biosimilar candidate for Simponi® and Simponi Aria® (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha. Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [2]. AVT05 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
[1] Based on quarterly filings from Johnson & Johnson
[2] https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI-pi.pdf
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
SOURCE: Alvotech
Post Views: 233
