VIRGINIA--(BUSINESS WIRE)--Alvotech today filed a federal lawsuit (Case 1:21-cv-00589) seeking to end the monopoly that pharmaceutical giant AbbVie has long-maintained on the adalimumab market, sold as Humira. Humira is the highest grossing prescription drug in the United States with over $16 billion in sales in 2020 (nearly $20Bn globally).
Alvotech has developed a biosimilar (analogous to a generic) of Humira called AVT02, the first-filed biosimilar drug equal in strength to Humiras latest formulation, which AbbVie markets as a high-concentration, pain-free drug. The company is also developing AVT02 as an interchangeable product and it expects results from its ongoing interchangeability study in Q2 of this year. AVT02 could save U.S. taxpayers and the overall healthcare system $8-10 billion annually.
Our new product will be a gamechanger that will provide consumers who are suffering from chronic pain with significant savings, and we look forward to bringing this drug onto the market as soon as possible, said Alvotech Founder and Chairman Robert Wessman.
As alleged in court today, AbbVie seeks to overwhelm Alvotech with 60+ patent claims of questionable validity in order to keep its closest competitor off the market, a tactic it has long used against other competitors. At stake are billions of dollars of cost to the U.S. healthcare system, which is largely driven by AbbVies significant price increases that its Humira monopoly makes possible. Later this month, AbbVie will face questions from Congress about whether the company improperly suppresses competition in order to maintain their monopoly.
As alleged in the filing, AbbVie has taken several improper steps to inflate its patent portfolio, specifically:
Today, affordable biosimilars to Humira are available across Europe and in Japan, Canada and Australia. The settlement agreements that allowed launches in 2018 of biosimilars in Europe were done to delay launches of similar products in the U.S., thus allowing AbbVie the ability to maintain and even increase prices on the U.S. consumer and taxpayer.
As pointed out in Alvotechs lawsuit, AbbVie did not invent adalimumab or the subject matter of the original patents surrounding adalimumab and its use, instead acquiring them from German BASF AG. Nevertheless, despite those original patents expiring in 2016, AbbVie has been able to extend its monopoly to 2023 and beyond by deliberately seeking to block legitimate competition.
In 2010, AbbVie developed and tested a less-painful and higher-concentration version of Humira that was as a 100 mg/ml formulation, which the FDA approved in 2015. Yet the company waited nearly three years before bringing this new formulation to the public, a strategic move meant to entrench their control over the market and hobble the competition. Alvotech has developed and is seeking interchangeability for the less-painful, high-concentration version of Humira, which will offer patients the treatment at a more affordable price point.
Furthermore, AbbVie successfully sought and obtained over 100 additional patents of dubious validity that extended its Humira monopoly beyond 2016. Through settlements reached with their competitors, other biosimilars will not enter the market until 2023.
In just the last four years, since its monopoly should have run its course, AbbVie has reported selling over $75 billion worth of Humira and is forecasted to make an additional nearly $40 billion through 2022.
As alleged in todays filing, this strategy has been called a minefield of IP by those in AbbVies leadership, meaning the company will engage in endless litigation not to protect innovation but to make challenges to its patent claims cost- and resource-prohibitive for competitors.
About Alvotech
Alvotech is a multinational biopharmaceutical company focused on the development and manufacture of high quality biosimilars for global markets. We are specialists in biotechnology, seeking to be a global leader in the biosimilar space by delivering high quality, cost-competitive products and services to our partners and to patients worldwide. Our fully integrated approach, with high-quality in-house competencies throughout the value chain, enables the accelerated development of biosimilar products. Alvotechs shareholder base includes, among others, Aztiq Pharma, led by founder and Chairman Mr. Robert Wessman, Fuji Pharma from Japan, Shinhan from Korea, Baxter Healthcare SA, YAS Holdings, ATHOS (Strngmann Family Office), CVC Capital Partners and Temasek from Singapore.
Alvotechs initial pipeline contains several monoclonal-antibody and fusion-protein biosimilar candidates aimed at treating autoimmunity, oncology and inflammatory conditions to improve quality of life for patients around the world. For more information, please visit our website, http://www.alvotech.com or follow us on LinkedIn, Twitter and Facebook.
- Pharmacist explains best diet to reduce arthritis, inflammation and joint pain - The Mirror - March 10th, 2024
- Teen Raises Funds to Fight Arthritis - Arthritis Foundation - March 10th, 2024
- Is there a higher risk of depression among specific populations of patients with rheumatoid arthritis? - News-Medical.Net - March 10th, 2024
- Here's How to Explain Your Arthritis Pain to Your Doctor So They Actually Get It - Northwest Georgia News - March 10th, 2024
- Despite Their Prevalence, Arthritis, Neck and Back Pain Receive Few Research Dollars, Analysis Finds | BIDMC of ... - Beth Israel Deaconess Medical... - March 10th, 2024
- This Is the Difference Between Rheumatoid and Psoriatic Arthritis - Prescott Daily Courier - March 10th, 2024
- The #1 Early Sign of Arthritis Most People Miss, According to a Rheumatologist - Northwest Georgia News - March 10th, 2024
- The Efficacy and Safety of Apremilast in the Management of Psoriatic Arthritis: A Systematic Review and Meta-Analysis - Cureus - March 10th, 2024
- MU Researchers Participating in International Clinical Study Targeting Prevention of Osteoarthritis - University of Missouri School of Medicine - March 10th, 2024
- Review: Real-World Evidence Confirms Effectiveness and Safety of Adalimumab Biosimilar SB5 - The Center for Biosimilars - March 10th, 2024
- A Gender-Bias-Mitigated, Data-Driven Precision Medicine System to Assist in the Selection of Biological Treatments of ... - Cureus - March 10th, 2024
- Young arthritis cases are on the rise, new research suggests - The Examiner - March 10th, 2024
- Quiz: ACR Guideline for the Treatment of Psoriatic Arthritis - MD Magazine - February 10th, 2024
- Psoriatic arthritis: What to know about medications for children - Medical News Today - February 10th, 2024
- Ancient Egyptian woman had holes on her bones. Experts say its rare case of disease - Miami Herald - February 10th, 2024
- Arthritis and Pregnancy: Fertility, Gestation, Postpartum - Verywell Health - February 10th, 2024
- 3500-year-old burial of Nubian woman reveals 1 of world's earliest known cases of rheumatoid arthritis - Livescience.com - February 10th, 2024
- Impact of frailty severity and severe pain on cognitive function for community-dwelling older adults with arthritis: a cross ... - Nature.com - February 10th, 2024
- IHL-675A: Advancing Towards Innovative Arthritis Solutions, with Mark Bleackley, PhD - MD Magazine - February 10th, 2024
- Insomnia, Shorter Sleep Duration Linked to the Risk of Autoimmune Arthritis - MD Magazine - February 10th, 2024
- Advancements in Psoriatic Arthritis Treatment for Children: A Beacon of Hope - Medriva - February 10th, 2024
- Breakthrough Molecule RvT4 Reverses Inflammation and Clears Arterial Blockages in Rheumatoid Arthritis Patients - SciTechDaily - February 10th, 2024
- Personal Experience with Psoriatic Arthritis and Atopic Dermatitis - Medriva - February 10th, 2024
- EULAR Recommendations on Imaging in Crystal-Induced Arthropathies (CiA) - Medriva - February 10th, 2024
- The Importance of Ultrasound-Guided Synovial Biopsy in the Workup of Seronegative Inflammatory Arthritis: A Case ... - Cureus - February 10th, 2024
- Autoimmune diseases like lupus, MS, and rheumatoid arthritis strike far more women than men. Scientists now think they know why - Fortune - February 2nd, 2024
- Multiple Ulcers in the Ileum and Lymphadenopathy Following the Usage of Methotrexate in a Patient With Rheumatoid ... - Cureus - February 2nd, 2024
- These are the best arthritis creams of 2024, according to health experts - Yahoo Life - February 2nd, 2024
- Do Your Joints Ache When a Storm Is Brewing? Here's What's Really Happening - DISCOVER Magazine - February 2nd, 2024
- Olympic bronze medalist opens up about balancing arthritis with motherhood and triathlon - TRI247 - February 2nd, 2024
- Some Dinosaurs May Have Had Arthritis 90 Million Years Ago - IFLScience - February 2nd, 2024
- 3500-year-old remains of ancient Egyptian suffering from rheumatoid arthritis uncovered - Xinhua - February 2nd, 2024
- Lupus and other autoimmune diseases strike far more women than men. Now there's a clue why - The Associated Press - February 2nd, 2024
- Rheumatoid Arthritis Awareness Day on February 2: What you need to know - CNBCTV18 - February 2nd, 2024
- Rheumatoid Arthritis Awareness Day 2024: Signs, Symptoms, Diagnosis, and Prevention - News18 - February 2nd, 2024
- Improving arthritis in cold weather | Health Smart - WPMT FOX 43 - February 2nd, 2024
- Rheumatoid Arthritis Awareness Day: History, Significance And All You Need To Know - ABP Live - February 2nd, 2024
- Dietary Factors Tied to Osteoarthritis Pain | MedPage Today - Medpage Today - February 2nd, 2024
- Cold-weather coping tips for people with arthritis, osteoporosis and lung diseases - Southernminn.com - February 2nd, 2024
- How to manage arthritis and joint pain: Effective tips for knee pain relief - Health shots - February 2nd, 2024
- New study illuminates the genetics of thumb arthritis treatment - News-Medical.Net - January 25th, 2024
- Rheumatoid arthritis: 30 minutes of walking may lower blood pressure - Medical News Today - January 25th, 2024
- RA Disease Activity Assessed Too Little After Starting TNFi - Medscape - January 25th, 2024
- Lifestyle tips for youth's bone health: Avoid these habits to prevent arthritis - Hindustan Times - January 25th, 2024
- Best arthritis pain relief cream of 2024, according to experts - AOL - January 25th, 2024
- Vasculitis, an Early Unusual Presentation of Rheumatoid Arthritis: A Case Report - Cureus - January 25th, 2024
- Patients with later menarche, earlier menopause have higher risk for rheumatoid arthritis - Healio - January 25th, 2024
- Investigating Maternal Inflammatory Arthritis and Pregnancy Outcomes < Yale School of Medicine - Yale School of Medicine - January 25th, 2024
- Rheumatoid Arthritis and Diabetes: What's the Connection? - Health Central - January 25th, 2024
- Oxidative DNA Damage and Zinc Status in Patients With Rheumatoid Arthritis in Duhok, Iraq - Cureus - January 25th, 2024
- Changes Afoot for the Treatment of Psoriatic Arthritis with Marked Gains in Preference and Utilization of IL-17 Inhibitors - Yahoo Finance - January 25th, 2024
- The Connection Between Potassium and Rheumatoid Arthritis - Health Central - January 25th, 2024
- What Is the ACR20 (American College of Rheumatology) Criteria? - Health Central - January 25th, 2024
- RA Treatment Advances and Where They Are Headed - Health Central - January 25th, 2024
- TMC Medical Minutes- Arthritis & Cold Weather - KXII - January 25th, 2024
- How to deal with joint and arthritis pain in the cold weather - Crossroads Today - January 25th, 2024
- Arthritis: Regular exercises, calcium-rich diet and other habits to keep your bones strong and healthy - Moneycontrol - January 25th, 2024
- Men With Arthritis Have Higher Fertility Rates, Study Finds - Zenger.News - January 25th, 2024
- Pain on Top of Foot: 5 Causes, Swelling, Treatment - Verywell Health - January 25th, 2024
- Understanding Rheumatoid Arthritis in Women: Genetics, Hormones, and Impact - Medriva - January 25th, 2024
- Arthritis | Johns Hopkins Medicine - January 9th, 2024
- Ideal cardiovascular health metrics have better identification of arthritis - BMC Public Health - BMC Public Health - January 9th, 2024
- Acupuncture for Arthritis: Benefits and Risks - Verywell Health - January 9th, 2024
- Why do arthritic horses have more trouble during the winter? - EQUUS Magazine - January 9th, 2024
- Rather than roll over and die, I'm like, 'No, I still want to play': Steve Morse says arthritis diagnosis forced him to ... - Guitar.com - January 9th, 2024
- Top Signs that Your RA Treatment May No Longer Be Working - Health Central - January 9th, 2024
- What Is The Life Expectancy Of Rheumatoid Arthritis? A Review By Doctors - MSN - January 9th, 2024
- Nature Coast Orthopaedics | arthritis care | medicare and most insurance accepted | Beverly Hills, FL | chronicleonline ... - Citrus County Chronicle - January 9th, 2024
- Millions of arthritis patients could struggle to get blockbuster drug, as CVS pulls it from pharmacies - Daily Mail - January 9th, 2024
- What Is Arthritis? | Arthritis Foundation - May 17th, 2023
- Procedure to Surgery for Arthritis Is Recommended After First Failed Non-Operative Therapy - DocWire News - March 29th, 2023
- Higher Prevalence of Sarcopenia Reported in Patients with Rheumatoid Arthritis - Rheumatology Network - October 7th, 2022
- Exploring the Relationship Between Psoriatic Arthritis and Psoriasis - Dermatology Times - October 7th, 2022
- Are Tomatoes Bad For Arthritis? Here's What An MD Has To Say - Women's Health - October 7th, 2022
- Tocilizumab for Treating ICI-Induced Arthritis and Colitis - DocWire News - October 7th, 2022
- Why Arthritis Is A Clear And Present Danger, And How We Can Fight It - CNBCTV18 - October 7th, 2022
- Arthritis: Five cruciferous veg 'block inflammatory process' - backed by 10-year study - Express - October 7th, 2022
- 5 Exercise Habits for Arthritis in Your 50s - Eat This, Not That - October 7th, 2022
- Arthritis: 8 types of fish can cause acid crystals to build up in joints - 'very painful' - Express - October 7th, 2022
- EMA Issues Positive Opinion on the Safety of Filgotinib - Medscape - October 7th, 2022