- SIMLANDI is the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S.
- SIMLANDI is the first biosimilar approval under the strategic partnership between Alvotech and Teva in the U.S. market
- SIMLANDI will qualify for interchangeable exclusivity in the U.S. for some concentration strengths
REYKJAVIK, Iceland & PARSIPPANY, NJ, USA I February 23, 2024 I 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 SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. In 2023, Humira was one of the highest grossing pharmaceutical products in the world, with sales in the U.S. of nearly $12.2 billion[1]. 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. While both low-concentration and high-concentration strength biosimilars of Humira are marketed in the U.S. today, nearly 88 percent of U.S. prescriptions for adalimumab are for the high-concentration presentation[2].
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.
“The approval of SIMLANDI marks the first high-concentration, citrate-free biosimilar to Humira with IC status,” said Dr. Eric Hughes, Executive Vice President Global R&D and Chief Medical Officer at Teva. “Biosimilars create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients. This approval marks an important milestone for Teva and Alvotech’s partnership to collaborate on seven biosimilars and expand the availability, access, and uptake of biosimilars in the U.S.”
Robert Wessman, Chairman and CEO of Alvotech, added, “This approval is an important milestone in Alvotech’s journey to offer broader access worldwide to more affordable biologics, following approvals of our biosimilars in other global markets. We strongly believe that biosimilars are important in addressing inflationary pressures in the healthcare system across all markets, especially in the U.S. where biologics represent well over 40 percent of all pharmaceutical spending. An interchangeable citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S.”
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 partners extended the partnership to include two additional biosimilars and two new presentations of previously partnered products. Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization, which leverages Teva’s extensive experience and sales and marketing infrastructure. SIMLANDI is the first interchangeable, high-concentration, citrate-free biosimilar approved under the strategic partnership. Both Alvotech and Teva expect to launch SIMLANDI in the U.S. imminently with interchangeability designation.
The FDA approval of SIMLANDI was based on a totality of evidence, including analytical, non-clinical, and clinical data. The clinical development program, included data from (i) AVT02-GL-101, a Phase I, multicenter, randomized, double blind, 3-arm study, to demonstrate pharmacokinetic (PK) similarity and compare safety and tolerability of SIMLANDI to Humira in healthy adult volunteers; (ii) AVT02-GL-301, Phase III, multicenter, double-blind, randomized, parallel-group active control study to demonstrate similar efficacy, and compare safety and immunogenicity of AVT02 versus Humira in patients with moderate-to-severe chronic plaque psoriasis and (iii) AVT02-GL-302, a Phase III, multicenter, randomized, double-blind, parallel-group study in moderate to severe chronic plaque psoriasis patients to demonstrate similar PK, and comparable efficacy, safety, and immunogenicity between patients receiving Humira and patients undergoing repeated switches between Humira and SIMLANDI.
Sources
[1] (AbbVie Full-Year and Fourth Quarter 2023 Financial Results): https://investors.abbvie.com/static-files/831c0d3d-8813-4942-b7af-a3dade33bea5
[2] Based on sales data from Symphony
Use of Trademarks
Humira® is a registered trademark of AbbVie Biotechnology Ltd.
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 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.
About Teva
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.
INDICATIONS FOR SIMLANDI (adalimumab-ryvk) injection
SIMLANDI is a tumor necrosis factor (TNF) blocker indicated for:
- Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. SIMLANDI can be used alone or in combination with methotrexate or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs).
- Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. SIMLANDI can be used alone or in combination with methotrexate.
- Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. SIMLANDI can be used alone or in combination with non-biologic DMARDs.
- Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS.
- Crohn’s Disease (CD): Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
- Ulcerative Colitis (UC): Treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
- Plaque Psoriasis (Ps): Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
- Hidradenitis Suppurativa (HS): Treatment of moderate to severe hidradenitis suppurativa in adult patients (1.8)
- Uveitis (UV): Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients (1.9)
Please click here for full Prescribing Information for SIMLANDI, including BOXED WARNINGS and Medication Guide.
SOURCE: Alvotech
Post Views: 514
- SIMLANDI is the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S.
- SIMLANDI is the first biosimilar approval under the strategic partnership between Alvotech and Teva in the U.S. market
- SIMLANDI will qualify for interchangeable exclusivity in the U.S. for some concentration strengths
REYKJAVIK, Iceland & PARSIPPANY, NJ, USA I February 23, 2024 I 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 SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. In 2023, Humira was one of the highest grossing pharmaceutical products in the world, with sales in the U.S. of nearly $12.2 billion[1]. 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. While both low-concentration and high-concentration strength biosimilars of Humira are marketed in the U.S. today, nearly 88 percent of U.S. prescriptions for adalimumab are for the high-concentration presentation[2].
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.
“The approval of SIMLANDI marks the first high-concentration, citrate-free biosimilar to Humira with IC status,” said Dr. Eric Hughes, Executive Vice President Global R&D and Chief Medical Officer at Teva. “Biosimilars create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients. This approval marks an important milestone for Teva and Alvotech’s partnership to collaborate on seven biosimilars and expand the availability, access, and uptake of biosimilars in the U.S.”
Robert Wessman, Chairman and CEO of Alvotech, added, “This approval is an important milestone in Alvotech’s journey to offer broader access worldwide to more affordable biologics, following approvals of our biosimilars in other global markets. We strongly believe that biosimilars are important in addressing inflationary pressures in the healthcare system across all markets, especially in the U.S. where biologics represent well over 40 percent of all pharmaceutical spending. An interchangeable citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S.”
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 partners extended the partnership to include two additional biosimilars and two new presentations of previously partnered products. Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization, which leverages Teva’s extensive experience and sales and marketing infrastructure. SIMLANDI is the first interchangeable, high-concentration, citrate-free biosimilar approved under the strategic partnership. Both Alvotech and Teva expect to launch SIMLANDI in the U.S. imminently with interchangeability designation.
The FDA approval of SIMLANDI was based on a totality of evidence, including analytical, non-clinical, and clinical data. The clinical development program, included data from (i) AVT02-GL-101, a Phase I, multicenter, randomized, double blind, 3-arm study, to demonstrate pharmacokinetic (PK) similarity and compare safety and tolerability of SIMLANDI to Humira in healthy adult volunteers; (ii) AVT02-GL-301, Phase III, multicenter, double-blind, randomized, parallel-group active control study to demonstrate similar efficacy, and compare safety and immunogenicity of AVT02 versus Humira in patients with moderate-to-severe chronic plaque psoriasis and (iii) AVT02-GL-302, a Phase III, multicenter, randomized, double-blind, parallel-group study in moderate to severe chronic plaque psoriasis patients to demonstrate similar PK, and comparable efficacy, safety, and immunogenicity between patients receiving Humira and patients undergoing repeated switches between Humira and SIMLANDI.
Sources
[1] (AbbVie Full-Year and Fourth Quarter 2023 Financial Results): https://investors.abbvie.com/static-files/831c0d3d-8813-4942-b7af-a3dade33bea5
[2] Based on sales data from Symphony
Use of Trademarks
Humira® is a registered trademark of AbbVie Biotechnology Ltd.
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 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.
About Teva
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.
INDICATIONS FOR SIMLANDI (adalimumab-ryvk) injection
SIMLANDI is a tumor necrosis factor (TNF) blocker indicated for:
- Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. SIMLANDI can be used alone or in combination with methotrexate or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs).
- Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. SIMLANDI can be used alone or in combination with methotrexate.
- Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. SIMLANDI can be used alone or in combination with non-biologic DMARDs.
- Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS.
- Crohn’s Disease (CD): Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
- Ulcerative Colitis (UC): Treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
- Plaque Psoriasis (Ps): Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
- Hidradenitis Suppurativa (HS): Treatment of moderate to severe hidradenitis suppurativa in adult patients (1.8)
- Uveitis (UV): Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients (1.9)
Please click here for full Prescribing Information for SIMLANDI, including BOXED WARNINGS and Medication Guide.
SOURCE: Alvotech
Post Views: 514
