- How a Drug Company Made $114 Billion by Gaming the U.S. Patent System (dnyuz.com)AbbVie’s global bestseller to face knockoffs starting this week (msn.com)
In 2016, a blockbuster drug called Humira was poised to become a lot less valuable...Through its savvy but legal exploitation of the U.S. patent system, Humira’s manufacturer, AbbVie, blocked competitors from entering the market. For the next six years, the drug’s price kept rising. Today, Humira is the most lucrative franchise in pharmaceutical history...Next week, the curtain is expected to come down on a monopoly that has generated $114 billion in revenue for AbbVie just since the end of 2016. The knockoff drug that regulators authorized more than six years ago, Amgen’s Amjevita, will come to market in the United States, and as many as nine more Humira competitors will follow this year from pharmaceutical giants including Pfizer. Prices are likely to tumble...READ MORE
- AbbVie slammed by FDA for improper handling of Humira death complaints: report (fiercepharma.com)
A number of AbbVie products coming out of its North Chicago, Illinois, manufacturing facility have been tied to death complaints, including its mammoth blockbuster Humira, and the FDA says the drugmaker has not done enough to investigate those complaints...FDA inspectors found that AbbVie had received five complaints tied to deaths after taking Humira and Venclexta. While the drugmaker reported those, it didn't go back and compile historical data about death complaints tied to drugs coming from the same lots. It turns out those lots had been tied to another 8 to 11 complaints each...an AbbVie spokeswoman countered the FDA observation, saying the company “investigates all complaints where a death has occurred during the use of our products,” and that “written complaint procedures are in place to investigate, analyze and resolve complaints.”...The FDA also found AbbVie's procedures for handling death complaints for products made at the plant “inadequate.”...no document showed that AbbVie evaluated complaints to see if there were other ones for nearby lot numbers or different strengths, or that it examined the reserve sample...the agency also warned AbbVie for not examining reserve samples at least once a year for evidence of deterioration, and for its failure to investigate drug batches manufactured close to a problematic one.
- Half of Americans Tested Misused Prescription Medications, Lab Tests Show (ptcommunity.com)
Quest Analysis of 3.4 million tests shows evidence of dangerous drug combinations...A majority of test results from patients taking prescription medications show signs of drug misuse—including potentially dangerous drug combinations...The Quest Diagnostics Health Trends study is based on analysis of the company's de-identified laboratory data, believed to be one of the largest nationally representative datasets of objective laboratory information of patients prescribed opioids and other commonly abused medications. Physicians order laboratory services to aid their ability to monitor patients for signs of prescription or illicit drug misuse or abuse...(The report, "Prescription Drug Misuse in America: Diagnostic Insights in the Growing Drug Epidemic")
- evidence of misuse has declined in recent years, 52% of test results showed evidence of potential misuse in 2016, suggesting a majority of patients took their prescribed drugs in ways that were inconsistent with their physician's instruction...
- disturbing patterns of concurrent drug use. Among more than 33,000 specimens tested for opioids, benzodiazepines, and alcohol in 2016, more than 20% were positive for both opioids and benzodiazepines, more than 10% were positive for both opioids and alcohol, and 3% were positive for all three...
- 19% of specimens positive for heroin in 2016 were also positive for nonprescribed fentanyl...
- drug misuse rates were high among most age groups and both genders. However, adolescents (10 to 17 years of age) showed a striking improvement, with the rate dropping from 70% to 29% between 2011 and 2016...
- Misuse rates were higher for men and women of reproductive age (58%) than in the general study population (52%)
- Why biosimilars could be market disruptors (biopharmadive.com)
Just as generic drugs revolutionized the small molecule space, biosimilars are poised to have a major impact on the development and commercialization of biologics. These highly similar, but not necessarily interchangeable drugs, have been part of the European drug market for years, but are just starting to emerge in the U.S. While still early days, the developing biosimilars market is one to watch.
- Hey, big spender: Pharma’s $6.6B TV ad outlay outranks most other industries, report says (fiercepharma.com)
Pharma is the fourth-largest spender on TV ads in the U.S., with $6.6 billion spent over the past year. That’s according to MediaRadar’s annual study of TV ad spending, which includes OTC drug ads in its total that push it higher than other tallies...While likely no surprise to most TV viewers, only retail ($8.7 billion), financial and real estate ($7.9 billion) and tech ($7.4 billion) serve up more TV ads than pharma. The industry edged out automakers ($6 billion), a traditional TV ad stronghold that’s been dropping media spend as car sales continue to decline...The top-spending pharma companies...Pfizer, AbbVie and GlaxoSmithKline. Pfizer spent most on brands Chantix and Eucrisa, while AbbVie spent on Humira, Orilissa and Mavyret. GSK spent more of its TV dollars on prescription product Breo Ellipta, but also on consumer brands Sensodyne and Flonase....READ MORE
- FDA warns ‘critical’ drug shortages possible after Hurricane Maria battered Puerto Rico (usatoday.com)
Patients could experience "critical shortages" of key pharmaceuticals, the U.S. Food and Drug Administration is warning after Hurricane Maria brought Puerto Rico's drug manufacturing industry to a standstill...The FDA said...it is taking active measures to help redirect production and preserve existing treatments to avoid a ballooning health crisis from Maria's destruction...The agency did not identify any specific medications that could be at risk of a shortfall, and a spokesperson was not immediately available to provide details...But there are "several" cases where "we may soon face critical shortages if we don’t find a path for removal or ways to get production back up and running," FDA Commissioner Scott Gottlieb said in a statement...Some companies are beginning to move product off of the island, and they’ve been communicating with the FDA about that and what potential challenges and limiting factors they see ahead...Drugs made on the island include AstraZeneca's cholesterol treatment Crestor, Abbvie arthritis drug Humira and Johnson & Johnson-owned HIV drug Prezista. Those three companies have said supplies of their drugs are in good shape...the catastrophic storm wiped out electricity for the entire island, devastated telecommunications and made travel nearly impossible for many employees of the island's nearly 50 pharmaceutical factories...
- Why the Biosimilar Drug Revolution Hasn’t Arrived (bloomberg.com)
In a word: patents...The Biologics Price Competition and Innovation Act (2010) was...part of the Affordable Care Act. Its essential goal was to infuse competition and lower the prices of drugs that were made from living cells -- so-called biologics...Until the 2010 law, biologics had no fear of competition -- there was no legal way to introduce generic versions into the market -- so they were able to maintain their monopoly price even after their patents expired. The BPCIA was intended to establish mechanisms within the Food and Drug Administration, the Patent and Trademark Office, and the courts that would allow the introduction of "biosimilars." These drugs weren't exact replicas of biologics, but were similar enough, and safe enough, to be used instead of the brand-name drugs...Here we are seven years later. Guess how many biosimilars have made it to market?..Two...companies are forced to fight through thickets of patents to get a biosimilar to market, a law that was supposed to save the U.S. billions will continue to do just the opposite: make it easy for biologic makers to maintain unwarranted monopolies...
- California Sues AbbVie Over Alleged Arthritis Drug Kickbacks (bloomberg.com)EU approves fifth copy of AbbVie's $18 billion drug Humira (reuters.com)
California’s insurance regulator is suing AbbVie Inc., alleging that the pharmaceutical giant gave illegal kickbacks to health-care providers in order to keep patients on its blockbuster rheumatoid arthritis drug Humira...The company “engaged in a far-reaching scheme including both classic kickbacks -- cash, meals, drinks, gifts, trips, and patient referrals -- and more sophisticated ones -- free and valuable professional goods and services to physicians to induce and reward Humira prescriptions...AbbVie paid for registered nurses that it called ambassadors to help doctors with patients who were taking Humira. While the nurses were represented to patients as an extension of the doctor’s office, they were trained to tout the drug while downplaying its risks...The allegations “are without merit,”...The company complies with state and federal laws governing interactions between health-care providers and patients...Its services help patients and “in no way replace or interfere with interactions between patients and their health-care providers...
- 7 Medical Conditions That Will Be Lining Big Pharma’s Pockets by 2020 (fool.com)
Big pharma stands to make hundreds of billions of dollars from a handful of medical conditions.
- No. 7: Viral hepatitis - $45 billion and $55 billion will be spent globally on drugs that treat viral hepatitis by 2022...around 257 million have chronic hepatitis B virus infection and 71 million people have chronic hepatitis C virus infection.
- No. 6: Respiratory diseases - treating respiratory diseases are expected to generate between $53 billion and $56 billion in sales by 2020. The most common respiratory diseases include asthma, allergies, and chronic obstructive pulmonary disease.
- No. 5: Autoimmune diseases - Autoimmune disease medications could make big pharma companies between $55 billion and $65 billion by 2020
- No. 4: Cardiovascular diseases - cardiovascular disease drugs will rack up sales between $73 billion and $76 billion by 2020...Cardiovascular drugs include treatments for hypertension, heart disease, and cholesterol.
- No. 3: Pain - Pain medications are projected to be the third-biggest moneymaker by 2020, with sales of $82 billion to $85 billion...drugs includes treatments for musculoskeletal pain, arthritis, anesthesia, analgesics (both narcotic and non-narcotic), and migraine.
- No. 2: Diabetes - diabetes drugs are expected to be near the top in spending, with projected global sales between $107 billion and $113 billion by 2020
- No. 1: Cancer - The top medical condition that will likely line big pharma's pockets by 2020 is cancer…sales of cancer drugs will be between $100 billion and $120 billion
- Top 5 Highest Grossing Specialty Drugs of the Year (specialtypharmacytimes.com)
Prescription drug spending has skyrocketed over the past few years, with many Americans struggling to access proper treatment. Lawmakers have attempted to address this issue, but it is likely that the trend of escalating drug spending will continue as costly specialty drugs dominate the market...All of the drugs that had the highest sales in 2016 are for specialty conditions, including autoimmune disorders and hepatitis C virus; however, the emergence of biosimilars may threaten their revenue into the future...
- 5. Infliximab (Remicade) - Johnson & Johnson and Merck report a 10.6% decrease in revenue from 2015, with infliximab generating nearly $7.83 billion in 2016...
- 4. Rituximab (Rituxan) - Partners Roche and Biogen reported total revenue of $8.58 billion for rituximab in 2016, which is a 2.7% increase from 2015. The drug is approved to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis...
- 3. Etanercept (Enbrel) - This autoimmune disease drug treats rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis. Amgen and Pfizer reported $8.87 billion in total sales for etanercept in 2016.
- 2. Ledipasvir/sofosbuvir (Harvoni) - When this drug hit the shelves, many patients with HCV and healthcare providers experienced sticker shock. The high cost of the curative drug and the prevalence of HCV have driven the $9.08 billion sales for the drug, according to the article.
- 1. Adalimumab (Humira) - In 2016, adalimumab grossed $16.08 billion in sales, which is a 14.7% increase in revenue for AbbVie, according to the article. The drug is approved to treat several autoimmune conditions, including rheumatoid arthritis, ulcerative colitis, and psoriasis.