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Good morning, everyone, and how are you today? We are just fine, thank you, given that a warm and shiny sun is enveloping the sedate Pharmalot campus. We use the word sedate because the mascots are happily snoozing and the short person has left for the local schoolhouse. As for us, we are scurrying about for interesting items and preparing for interesting interactions. As for you, here are some tidbits. Have a great and productive day….

Pfizer will sell a biosimilar version of the Remicade rheumatoid arthritis treatment next month at a 15 percent discount off the list price of the brand-name drug, which is sold by Johnson & Johnson. Known as Inflectra, the medicine will become the second biosimilar in the US market and arrive before the drug makers settle patent litigation. The move will likely spark a battle to sway insurers. Remicade notched $4.5 billion in sales last year.

Valeant Pharmaceuticals is ending its relationship with a mail-order pharmacy that helped sell Wellbutrix XL, one of several older drugs it acquired before boosting prices, Bloomberg News writes. The antidepressant is its second-biggest selling product, even though cheaper generic copies became available about a decade ago. Valeant raised the list price 11 times in two years to $17,000 annually by the beginning of 2016.


Sen. Richard Blumenthal (D-Conn.) wants the Department of Justice to reject a recent $465 million settlement with Mylan Pharmaceuticals for shortchanging Medicaid. The company incorrectly classified EpiPen as a brand-name product, instead of a generic, which allowed it to pay lower rebates.  “This proposed agreement is a shadow of what it should be — lacking real accountability for Mylan’s apparent lawbreaking,” he says.

The UK’s National Institute of Health and Care Excellence proposed a plan to fast-track recommendations for the most cost-effective new drugs that would clear them up to three months faster than the current system, Reuters tells us. The new process will apply to drugs with a likely cost-per-quality adjusted life year of up to $12,500. For these products, final NICE guidance would be published immediately after a drug wins its official marketing license.


After banning 344 fixed-combination drugs earlier this year, the Indian government may turns its attention to another 500 medicines, The Economic Times reports. The central drug regulator has sent letters to nearly 300 companies, which have sought marketing approvals for fixed dose combination drugs and asked them to conduct Phase IV trials — also known as post-marketing studies — as evidence their medicines are safe and effective.

Bayer’s promises of soaring sales for its experimental pipeline of drugs, which hinges in part on an unproven treatment for an uncommon cancer, are being met with skepticism, Bloomberg News writes. The first big challenge will be achieving success with a drug being tested in patients with mesothelioma, a tumor caused by asbestos exposure that affects the thin layer of tissue around key organs.

The US asked the United Nations to add two chemicals used to make illicit batches of fentanyl to a list of controlled substances that regulates narcotics internationally, The Wall Street Journal informs us.

Depomed and activist shareholder Starboard Value have ended their battle over the drug company’s board, which will add three Starboard nominees, The Wall Street Journal says.

  • A discount of 15% on the Remicade-biosimilar is certainly an under-delivery of promised savings. It was disheartening in 2011 when a BioNJ program on biosimilars predicted a 30% savings – 15% under-performs even that low (or high?) bar. (Then again, it may be a larger savings against the venerable bioidentical of Remicade – which we call Humira? If that sounds odd, do consult the history of litigation around those products.)

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