- Drugmakers ‘hijacked’ the FDA’s orphan system to score premium pricing on mass-market meds: report
There’s no denying that financial incentives for orphan drug development spawned meds that have saved hundreds of thousands of lives. But they’ve also helped mass-market drugmakers rack up millions in incentives, tax breaks and patent-protected profits—in some cases through monopoly pricing...About one-third of the orphan drug approvals the FDA doled out since the program began more than 30 years ago have been for repurposed, large-market products or drugs with multiple orphan green lights...Best-sellers such as Crestor…,Abilify…,Herceptin…,and Humira...fall into the category of big sellers whose makers snagged millions in government incentives—not to mention seven years of exclusive rights on the market—when they resubmitted their therapies as treatments for smaller populations...What we are seeing is a system that was created with good intent being hijacked…Repurposing a drug isn’t necessarily a bad thing, of course, if it can help get a treatment to additional patients...But when the orphan incentives allow competition-free drugmakers to charge whatever prices they want for their meds?...Now...it seems like...this practice may be driving up prices...Industry lobby groups...are unsurprisingly in favor of maintaining the status quo. With rare diseases “tragically killing and brutalizing mostly children,” incentives for orphan drugmakers should be kept in place...the risk of losing incentives in the system far outweighs the benefit of trying to save a few pennies on the health care dollar...
- Spending On Drugs Will Drop As Top Sellers Go Generic (forbes.com)
...IMS Health disclosed that total spending on prescription drugs in 2015 rose 12.2% to almost $425 billion. Since drug pricing continues to be a major topic of discussion...What is striking about the newly released data are the drugs Americans spend the most on... cholesterol-lowering drug Crestor, with sales of $6.3 billion...this will soon become moot as Crestor will lose patent protection and become a generic drug, an event that will likely drive down its cost by as much as 90%...rheumatoid arthritis drug, Amgen’s Enbrel, with U.S. sales of $6.6 billion last year. The FDA is now reviewing a biosimilar version of Enbrel which was filed by...Sandoz...Given that Zarxio was launched at a 15% discount to Neupogen, a similar discount could be anticipated for a biosimilar Enbrel...rheumatoid arthritis, Humira (adalimumab) from AbbVie . Many analysts believe that Humira’s $10.6 billion in 2015 revenue will be severely impacted by biosimilars being developed by Merck, Amgen, Pfizer and others...one might expect even larger discounts than 15%...the top drug with respect to spending in the, the hepatitis C drug Harvoni from Gilead, weighing in at $14.3 billion. It is unlikely that the sales of this drug will decrease any time soon. However, the use of hepatitis C drugs to cure this infection will reduce the incidence of liver cancer, thereby lowering overall costs to the healthcare system over the coming years...there will be new–and expensive–breakthrough drugs emerging from the pipelines of the biopharmaceutical industry. But let’s not lose sight of the fact that these same drugs that save lives or alleviate the suffering of millions, eventually will become a lot cheaper.
- Takeda aims to unlock $2B in Entyvio sales with multipronged DTC push (fiercepharmamarketing.com)
Takeda is going behind closed doors with its first DTC campaign for Entyvio (vedolizumab), a new biologic treatment for inflammatory bowel diseases. Bathroom doors, that is...The Japanese drugmaker uses a series of bathroom doors in its ad campaign, asking if it's "time for a different perspective." A...TV spot launched Feb. 7...has racked up $2.9 million on more than 2,000 airings...This condition is such an isolating condition and such a stressful condition. Patients are kept from doing the important things they want to be doing in their lives and as a result they miss out on a lot...In testing many different creative ideas with Crohn's and ulcerative colitis patients...the bathroom doors resonated well because patients noted it is a view they are all too familiar with...But some patients even took it to the next level in saying that the doors metaphorically represent that barrier between their disease and being able to do all of the things they want to do. Emotionally, we've touched upon the reality of their disease in a very obvious bathroom door representation, but also a representation of just barriers in general...Analysts have projected blockbuster-level sales for Entyvio by 2020...Marketing will be key to gaining share in a crowded IBD space where it's up against established...brands such as AbbVie's Humira, Amgen's Enbrel, and Johnson & Johnson's Remicade...
- 10 Best-Selling Brand-Name Drugs in 2015 (pharmacytimes.com)
10 best-selling brand-name drugs have generated $48.5 billion in sales this year through June 2015,…gross sales from the following 10 drugs comprise 43% of the nearly $112.5 billion in total drug sales generated by the 100 best-selling drugs..
- Humira (Abbott) - $8.6 billion
- Abilify (Otsuka) - $7.2 billion
- Enbrel (Amgen) - $6.1 billion
- Crestor (AstraZeneca) - $6.1 billion
- Lantus Solostar (Sanofi-Aventis) - $5 billion
- Sovaldi (Gilead Sciences) - $4.9 billion
- Advair Diskus (GlaxoSmithKline) - $4.8 billion
- Nexium (AstraZeneca) - $4.7 billion
- Januvia (Merck) – $3.8 billion
- Lyrica (Pfizer) - $3.4 billion
- Two biosimilars approved, but litigation delays launch (pharmacytoday.org)
FDA recently approved the first biosimilars for adalimumab (Humira—AbbVie) and etanercept (Enbrel—Amgen), known as adalimumab-atto (Amjevita—Amgen) and etanercept-szzs (Erelzi—Sandoz), respectively. These approvals came after unanimous votes of support by FDA’s Arthritis Advisory Committee in July. Unfortunately, the launch of both biosimilar products will be delayed because the manufacturers of the reference products are involved in litigation against biosimilar manufacturers for patent infringement...A recent meta-analysis...suggest these products have nearly identical pharmacokinetics, efficacy, and toxicity…Although the trials cited by this meta-analysis involved limited numbers of patients, there is no reason to suspect these biosimilars will not be nearly identical to their reference product...
- Exclusive: Makers took big price increases on widely used U.S. drugs (reuters.com)
Major drug companies took hefty price increases in the U.S., in some cases more than doubling listed charges, for widely used medications over the past five years...Prices for four of the nation's top 10 drugs increased more than 100 percent since 2011...Six others went up more than 50 percent. Together, the price increases on drugs for arthritis, high cholesterol, asthma and other common problems added billions in costs for consumers, employers and government health programs...Routine price increases by bigger players may draw less attention, but they add up. Sales for the top 10 drugs went up 44 percent to $54 million in 2014, from 2011, even though prescriptions for the medications dropped 22 percent...At the top of the list was AbbVie Inc...which raised the price of...Humira (adalimumab) more than 126 percent...Amgen Inc and Teva Pharmaceutical Industries Ltd, which raised prices for arthritis treatment Enbrel (etanercept) and multiple sclerosis drug Copaxone (glatiramer) by 118 percent.
- U.S. patent office rules against Amgen Humira challenge (reuters.com)
U.S. patent officials...denied petitions by Amgen to review two formulation patents on AbbVie's Humira, a potential setback in Amgen efforts to market a biosimilar version of the world's top-selling prescription medicine...In June, Amgen...asked the U.S. Patent and Trademark Office for the review, arguing that the patents in question should not have been granted in the first place for Humira, an injected rheumatoid arthritis treatment with annual sales approaching $14 billion...In declining to review the patents, the agency said "we determine, based on the petition and the accompanying evidence, that Amgen has not shown a reasonable likelihood of prevailing on any of its challenges."...Amgen said it still plans to challenge the legality of the patents.
- Pharma brings the heat in July as TV ad spending soars (fiercepharma.com)
Pharma marketers must have missed the memo about the dog days of summer. TV spending by the top 10 pharma advertisers topped $140 million, making the total for July the highest since January, according to data from real-time TV ad tracker iSpot.tv...Disease awareness campaigns were prominent last month, with two marketers debuting in the top 10 group. Merck, which began a campaign to promote the importance of HPV vaccinations in June, landed at No. 7, spending $9.9 million split between that HPV ad and an ongoing campaign aimed at encouraging shingles vaccinations for older people. Merck markets Gardasil for HPV and Zostavax for shingles...July was also a big month for diabetes marketers on TV, with total spending of $64 million on TV ads for the month. That category was led by Pfizer’s Lyrica, which maintained the No. 2 spender spot for the third month in a row...Watch the ads...
- Humira (adalimumab) - "Teacher"
- Lyrica (pregabalin) - "Coach"
- Xeljanz XR (tofacitinib) - "Mother"
- Entresto (sacubitril/valsartan) - "Tomorrow"
- Toujeo (insulin glargine) - "Journal"
- Eliquis (apixaban) - "DVT and PE Blood Clots"
- Merck disease awareness ads - "HPV Vaccination"
- Victoza (liraglutide) - "Moment of Truth"
- Mylan disease awareness ads - "Allergic Reactions"
- Tresiba (insulin degludec) - "Ready"
- Samsung brings in the lawyers for biosimilars push (reuters.com)Samsung Bioepis files lawsuit against AbbVie on Humira patents (koreaherald.com)
Samsung Bioepis Co Ltd, which aims to become a force in the fledgling biosimilar drugs industry, has filed a lawsuit against the originator of the world's best-selling drug, to stop it blocking the launch of its own version...Samsung Group...along with...Biogen, filed suit...against AbbVie Inc, maker of rheumatoid arthritis drug Humira (adalimumab), which generated sales of $14 billion last year...patent for Humira loses its exclusivity in the United States in December 2016...AbbVie...has been filing new patents in a bid to push back sales of biosimilars...more than a dozen firms have challenged AbbVie’s strategy through patent authorities or the courts...We believe that AbbVie has been attempting to obstruct market entry of competing products by applying for a large number of overlapping patents around Humira, which could affect patient access to affordable medication...
- The Best-Selling Drugs in the World By 2020 (fool.com)
..Humira's dominance as the best-selling drug in the world expected to come to an end in the coming years, look for these drugs to potentially take its spot…Last year global pharmaceutical sales topped the $1 trillion mark for the first time ever. By 2018…predicts sales will rise by another 30% to $1.3 trillion. This is a major growth opportunity for investors, but only if they understand what blockbuster drugs are on their ascent, and which ones could be on the decline…I'd keep my eye on a handful of therapies to step up as the best-selling drugs in the world by 2020.
- Harvoni (ledipasvir/sofosbuvir)
- Revlimid (lenalidomide)
- Aducanumab (investigational, BIIB037)