Libbs Farmacêutica Ltda.

Alvotech is one of two companies known to have initiated a global or multi-country confirmatory patient study for a biosimilar candidate to Entyvio® Sales of Entyvio (vedolizumab) were about $5.4 billion globally in the last 12 months up to June 30, 2024 Entyvio is indicated for the treatment of Ulcerative Colitis and Crohn’s disease Sept. 25, 2024 -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a confirmatory patient study for AVT16, a biosimilar candidate to Entyvio® (vedolizumab). The objective of the study is to demonstrate comparative efficacy, safety, and immunogenicity of AVT16 and Entyvio, in male and female participants 18-80 years old with moderate to severe active Ulcerative Colitis. Alvotech is one of two companies known to have initiated a global or multi-country confirmatory patient study for a biosimilar candidate to Entyvio. Entyvio (vedolizumab) is indicated for the treatment of adult patients with moderate to severe Ulcerative Colitis, a disease causing inflammation and ulcers in the lining of the bowel, and moderate to severely active Crohn’s disease, a disease causing inflammation of the digestive tract. In the last twelve months until June 30, 2024, combined net revenues worldwide from sales of Entyvio were about US$5.4 billion [1]. “We are proud to be able to initiate the confirmatory patient study for AVT16, adding another important biosimilar candidate in clinical development to our pipeline. Alvotech’s growing pipeline and portfolio of marketed biosimilars, leveraging our dedicated comprehensive R&D and manufacturing platform, demonstrates our commitment to improving people’s lives globally by increasing access to cost-effective biologic medicines,” said Joseph McClellan, Chief Science Officer of Alvotech. The AVT16-GL-C01 multicenter study has a double-blind parallel design with 2 arms. Participants will receive either AVT16 or Entyvio, and all participants will be followed to determine efficacy of the treatment using a standardized score for Ulcerative Colitis disease activity. Alvotech’s current biosimilars portfolio targets autoimmune disease, eye disorders, bone disease, respiratory disease, and cancer. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. Alvotech expects to file marketing applications for three biosimilar candidates in the course of 2024, while AVT16 is one of six disclosed biosimilar programs in earlier stages of development. AVT16 is a human monoclonal antibody and a biosimilar candidate to Entyvio® (vedolizumab). Vedolizumab targets and binds specifically to the alpha-4-beta-7 protein, which is preferentially expressed on T helper lymphocytes (white blood cells) which migrate into the gastrointestinal tract and cause inflammation characteristic of Ulcerative Colitis and Chron’s disease [2]. AVT16 is an investigational product and has not received regulatory approval in any country. Biosimiliarity has not been established by regulatory authorities and is not claimed. AVT02 is a monoclonal antibody and has been approved as a biosimilar to Humira® (adalimumab) in over 50 countries globally, including the U.S., Europe, Canada, Australia, Egypt, Saudi Arabia and South Africa. It is currently marketed in the U.S. as SIMLANDI and under private label, in Europe as HUKYNDRA, in Canada as SIMLANDI and in Australia as ADALACIP. Dossiers are also under review in multiple countries globally. AVT04 is a monoclonal antibody and a biosimilar to Stelara® (ustekinumab). It has been launched in Canada as JAMTEKI, in the EEA as UZPRUVO, and in Japan as USTEKINUMAB BS (F). It has been approved in the U.S. as SELARSDI. Dossiers are also under review in multiple countries globally. Sources [1] IQVIA [2] Entyvio product information, EMA. 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. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed 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), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), 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 https://www.alvotech.com. The content above comes from the network. if any infringement, please contact us to modify.

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva SELARSDI is expected to be marketed in the U.S. on or after February 21, 2025, following a settlement agreement with Johnson & Johnson, the manufacturer of Stelara SELARSDI was developed and is manufactured by Alvotech using murine cell (Sp2/0) and a continuous perfusion process, which are the same type of cells and process used for the production of Stelara April 16, 2024 -- Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara®, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older. Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of SELARSDI in the United States. “The approval of SELARSDI – which is our second biosimilar approval this year – underscores Teva’s commitment to expanding the availability, access and uptake of this important treatment option to patients in the U.S.,” said Thomas Rainey, Senior Vice President, U.S. Market Access at Teva. “The biosimilars market is growing, both globally and in the U.S., and biosimilars are a key component of delivering on Teva’s Pivot to Growth strategy. The partnership model that we’ve established enables us to leverage our commercial presence and experiences globally as we move to bring additional biosimilars to market.” Robert Wessman, Chairman and CEO of Alvotech, added, “We are delighted to announce our second biosimilar approval in the U.S., which is the thirty-eighth approved market for our biosimilar to Stelara globally. Bringing SELARSDI to market in the U.S. early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs. The development of SELARSDI leveraged our purpose-built end-to-end development and manufacturing platform for biosimilars. Being able to develop the biosimilar in the same cell type and continuous perfusion process as was used for the reference product, facilitated the development program’s success.” Ustekinumab is a human monoclonal antibody (mAb) that selectively targets the p40 protein, a component common to both interleukin (IL)-12 and IL-23 cytokines, which play crucial roles in treating immune-mediated diseases like psoriasis and psoriatic arthritis. Alvotech developed and produces SELARSDI using Sp2/0 cells and a continuous perfusion process, which are the same type of host cell line and process used in the production of Stelara. Sales of the reference product Stelara in the U.S. were nearly $7 billion in 2023.1 The availability of a Stelara biosimilar will create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients. In the U.S., plaque psoriasis is the most common form of psoriasis while psoriatic arthritis accounts for approximately six percent of all cases of juvenile arthritis.2,3 In June 2023, Alvotech and Teva announced that they had reached a settlement and license agreement with the manufacturer of the reference biologic, Johnson & Johnson, granting a license entry date for SELARSDI in the United States no later than February 21, 2025. In August 2020, Alvotech and Teva entered into a strategic partnership for the exclusive commercialization of five of Alvotech’s biosimilar product candidates, and in August 2023, the collaboration was extended to include two additional biosimilars and new presentations of two previously partnered products. Alvotech handles development and manufacturing, while Teva is responsible for the exclusive commercialization in the U.S., which leverages Teva’s experience and extensive sales and marketing infrastructure. SELARSDI is the second biosimilar approved under the strategic partnership: in February 2024, the FDA approved SIMLANDI®, the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA. The FDA approval of SELARSDI, referred to as AVT04 during development, was based on a totality of evidence, including analytical and clinical data. The clinical development program included data from: 1) Study AVT04-GL-301, a randomized, double blind, multicenter, 52-week study to demonstrate equivalent efficacy and to compare safety and immunogenicity between SELARSDI and the reference product Stelara in patients with moderate to severe chronic plaque-type psoriasis. The study was conducted in four countries in Europe and enrolled 581 patients. The primary efficacy endpoint was Psoriasis Area and Severity Index (PASI) percent improvement from Baseline to Week 12; 2) Study AVT04-GL-101, a Phase I, randomized, double-blind, single-dose, parallel-group, 3-arm study to compare the pharmacokinetic, safety, tolerability, and immunogenicity profiles of SELARSDI, administered as a single 45mg/0.5mL subcutaneous injection with that of the US-licensed Stelara as well as EU-approved Stelara. The study was conducted in Australia and New Zealand and enrolled 294 healthy adult volunteers. Use of Trademarks Stelara® is a registered trademark of Johnson & Johnson. Humira® is a registered trademark of AbbVie Biotechnology Ltd. 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 includes eight disclosed 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. Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com. The content above comes from the network. if any infringement, please contact us to modify.

The study, which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints Prolia® and Xgeva® (denosumab) are indicated for the treatment of bone disease 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 (PK) study for AVT03, a biosimilar candidate to Prolia® and Xgeva®, which both contain denosumab. 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. “We are very pleased with the progress in our AVT03 program. 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. Xgeva, which is also denosumab but in a different presentation, is indicated for prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone. It is also indicated for the treatment of giant cell tumor in bone. In the last twelve months before September 30, 2023, reported combined net revenues worldwide from sales of Prolia and Xgeva were over US$6 billion, based on the manufacturer’s reported quarterly sales. AVT03 is a human monoclonal antibody and a biosimilar candidate to Prolia® and Xgeva® (denosumab). Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction [1]. AVT03 is an investigational product and has not received regulatory approval in any country. Biosimiliarity has not been established by regulatory authorities and is not claimed. [1] https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf 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 includes eight disclosed 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. The content above comes from the network. if any infringement, please contact us to modify.