Red Tape, Lawsuits Tangle Biosimilar Approval Process, Keeping Biologic Prices Sky High

The Associated Press: Insider Q&A: Why So Little Relief On Pricey Biologic Drugs
Drugs made from living cells, instead of by mixing chemicals, have brought major advances since the late 1990s to the treatment of various cancers, immune system disorders, growth hormone deficiency and eye diseases. But the drugs, called biologics, often have enormous price tags — up to hundreds of thousands of dollars a year, with crushing out-of-pocket costs for many patients. Part of the problem is that until recently there was no system in place for U.S. regulators to approve cheaper “generic” competition for these treatments because exact copies can’t be made. (9/18)

Modern Healthcare: Generic Drugmakers Tout Competition Bill As Pressure Builds To Tackle Drug Costs
The generic drug industry, responding to public anger over big price hikes for some generic products, is calling for action on a bipartisan Senate bill it says would increase the number of cheaper generic drugs and reduce U.S. drug spending. Meanwhile, broader congressional efforts are building to hold both generic and brand-name drug manufacturers accountable for price spikes. Drugmakers would have to justify price hikes of 10% or more and disclose the information behind those pricing decisions under a separate bipartisan Senate bill called the Fair Drug Pricing Act. (Meyer, 9/18)

Bloomberg: Valeant Drug Discounts Haven’t Materialized, Hospitals Say 
Months after Valeant Pharmaceuticals International Inc. said it would make discounts available to U.S. hospitals for two high-priced heart drugs, some medical centers say they have yet to see a cent of savings. Valeant became the face of high American drug prices when it acquired Isuprel and Nitropress last year and immediately raised their prices by 525 percent and 212 percent. Facing a backlash, representatives from the company stood before Congress in April and said they would work to cut prices for the drugs. (Koons and Hopkins, 9/16)

The Wall Street Journal: Allergan To Buy Tobira Therapeutics In $1.7 Billion Deal
Allergan PLC on Tuesday said it agreed to acquire Tobira Therapeutics Inc., a biopharmaceutical company that develops therapies for liver diseases, in a deal worth as much as $1.7 billion, or 19 times Tobira’s previous market value. Tobira focuses on products that treat nonalcoholic steatohepatitis, or NASH, a common liver disease associated with obesity and type-2 diabetes. NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage, and it can lead to scarring of the liver and progress to cirrhosis, liver cancer and eventual liver failure. (Stynes, 9/20)

Bloomberg: Behind Battle Over Drug Prices, Quiet Money From Big Pharma
Nothing about a Washington state lawsuit called B.E. v. Teeter is as simple as it seems. It was filed this year by two hepatitis C patients against the state's Medicaid program to help the poor gain access to drugs such as Gilead Sciences Inc.'s $1,000-a-pill cure. But behind the team bringing the case is Gilead itself. While the drug giant isn't involved in the lawsuit, the company and its foundation have donated hundreds of thousands of dollars to the researchers, lawyers, patient advocates and medical expert who have helped build the case. (Martin and Glovin, 9/19)

FiercePharma: A Silver Lining To The Drug-Pricing Uproar? For Generic Competition, Yes, GPhA Chief Says
With drug prices dominating attention in Congress and agitating the public, GPhA CEO Chip Davis wants to be sure low-cost generics are top of mind as a way to save money--and he has some ideas to amp up their strength in the marketplace. Answering some recent news about "extraordinary" generic price increases, Davis emphasized in a presentation on Monday that those hikes were few and far between in the copycat-drug universe. If you're looking for drug-cost drivers, look no further than specialty drugs, which in 2014 accounted for 31.8% of spending on 1% of the population, said Davis, who heads up the Generic Pharmaceutical Association. (Sagonowsky, 9/20)

Stat: Colombia Plans To Proceed With Price Cut On Novartis Cancer Drug
After weeks of deliberations, the Colombia health minister is proceeding with plans to unilaterally lower the price of a Novartis cancer drug that has become the latest symbol of the battle between access to medicines and intellectual property rights. The amount of the reduction has not been announced, but Colombia media reported Health Minister Alejandro Gaviria may drop the price for Gleevec by up to 45 percent. Patient advocacy groups note that the annual cost of the drug is roughly $15,000, compared with per capita gross national income of about $8,000. This would amount to “significant savings for the whole health system,” the patient groups said. (Silverman, 9/16)

Kaiser Health News: Candidates Decry High Drug Prices, But They Have Few Options For Voters
In this year’s presidential campaign, health care has taken a back seat. But one issue appears to be breaking through: the rising cost of prescription drugs. The blockbuster drugs to treat hepatitis C as well as dramatic price increases on older drugs, most recently the EpiPen allergy treatment, have combined to put the issue back on the front burner. (Rovner, 9/16)

CBS News: Even Generic-Drug Prices Are Going Through The Roof
The good news: U.S. consumers still get more bang for their buck from generic drugs as prices of the cheaper versions of the originals are generally falling. The bad news: Recent years have seen an increasing count of sharp cost spikes for generics -- the drugs produced after the patents on their branded versions expire. “The broader picture of generic costs is the decline over time, and the lower prices traditionally seen,” said John Dicken, director of health care issues at the Government Accountability Office (GAO), the agency Congress has tasked with investigating how taxpayer money is spent. (Gibson, 9/16)

California Healthline: Veterans Courted In California’s Ballot Fight Over Curbing Drug Prices
Once a month at the Veterans of Foreign Wars building in Sacramento, a couple dozen former soldiers, many with white hair tucked under their service caps, stand and salute as they take up matters close to their communities. For discussion at a recent meeting: proper burial services for homeless veterans and a Harley Davidson motorcycle BBQ fundraiser. Also on the agenda: California’s Proposition 61 — a controversial measure on the November ballot that aims to rein in prescription drug prices. (Bartolone, 9/21)

Stat: Sarepta's CEO: 'This Is A Learning Process For Us And The FDA'
After months of controversy, the Food and Drug Administration on Monday approved a Sarepta Therapeutics drug for Duchenne muscular dystrophy, a rare disease that confines boys to wheelchairs and sends them to an early death. But debate continues over whether the FDA lowered standards to approve a drug for an unmet medical need. And the price is a concern, too. The drug will cost about $300,000 per patient per year, depending upon weight, which means the price can run much higher. We spoke briefly with Dr. Ed Kaye, the interim Sarepta chief executive, about the approval. This is an edited version of the conversation. (Silverman, 9/20)

Medpage Today: FPs Decry Soaring Drug Prices
Family physicians are frustrated with the rising cost of prescription drugs and they took that frustration to the the American Academy of Family Physicians Congress of Delegates today demanding action from the AAFP board. The delegates made their case with a trio of resolutions debated before the AAFP's advocacy reference committee. (Basen, 9/19)