Pfizer filed a Citizen Petition with the FDA requesting regulators issue guidance to “…ensure truthful and non-misleading communications by sponsors concerning the safety and effectiveness of biosimilars….” With lagging performance from its Remicade copy, Inflectra, as the backdrop, Pfizer is calling BS on innovators’ communications regarding biosimilars, which Pfizer believes intentionally confuse consumers and prescribers and erode confidence biosimilars. Specifically, Pfizer notes how J&J describes that biosimilars act in a “similar” way to Remicade when, in fact, they employ the same mechanism of action. Amgen claims that switching to a biosimilar “carries risk” if your current product is working. And Genentech states that biosimilars are “highly similar but not identical” to branded products. Pfizer claims that’s only half the story. While Pfizer’s motives are almost certainly not altruistic in nature, they probably have a point about intentional marketing half-truths.
While it may sound like the plot for the latest Mission Impossible film, we assure you it’s real life. Five companies—AstraZeneca, General Electric, Johnson & Johnson, Pfizer, and Roche—are under investigation by the US Department of Justice for their alleged involvement in an Iraqi corruption scandal. The investigation follows a lawsuit filed on behalf of American service members which alleges these companies sold and donated medical supplies to the (then) corrupt head of the Iraqi Ministry of Health, who then sold these supplies to fund terrorist militias. Obviously, the companies are denying their involvement in the unsavory terrorist aspect of this story, and the defendant’s filing in the lawsuit points out that the US government encouraged these sales and donations at the time. This action thriller writes itself…
Quick question. How many different “flavors” of J&J’s Remicade can you buy? Currently there are three, but more a coming. You can be prescribed Remicade (2016 sales of $4.45 billion), or Pfizer’s biosimilar Inflectra, or Samsung’s biosimilar Renflexis, and soon you might be able to get it from Amgen or Sandoz. When initially launched, Pfizer’s Inflectra was priced at a 15% discount to Remicade. Then Renflexis recently launched at a 35% discount. Just before the Renflexis launch, Pfizer knocked off another 4% to get to a 19% discount. What does J&J have to say about this? Sales of Remicade have not fallen as much as analysts predicted. Biosimilars are tricky and huge sales are at stake. Stay tuned, these battles are just beginning.
Cancer…the c-word is cancer. Grail, a Silicon Valley startup, is developing a blood test similar to a liquid biopsy that works proactively to spot cancer. According to Business Insider, the goal is to “identify the tiny bits of cancer DNA that are hanging out in our blood but are now undetectable.” A test like that will take time, massive clinical trials and, of course, money. Lucky for them, Grail just raised more than $900M in funding from big names like Johnson & Johnson Innovation, Bristol-Myers Squibb, Celgene, McKesson Ventures, Merck, Tencent Holdings Limited, Varian Medical Systems, and even Amazon. Who knows, maybe Prime members can get test results delivered to their front door in less than two business days.
J&J got a thumbs down from a US district court regarding a patent on its blockbuster drug, Remicade, opening the door for biosimilar entries to the US market. Celltrion and Pfizer’s Hospira have their infliximab biosimilar, Inflectra, ready and raring to go for a launch as early as October 3. The biosimilar is already available in Europe and has been stealing a significant chunk of Remicade sales. However, J&J is planning to appeal the court’s ruling and considers a biosimilar launch prior to the outcome of the appeal to be an “at-risk launch.” Whether Celltrion and Pfizer will take that risk remains to be seen. Also TBD is how formularies will treat the products post-biosimilar entry. Will Remicade be blacklisted in favor of its sure-to-be-cheaper twin?