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…
Earlier this week, FDA granted its first approval as a part of two new pilot programs that aim to make the development and review of cancer drugs more efficient. The drug is Novartis’ Kisqali and the two programs are the Real-Time Oncology Review (allows for the FDA to review much of the data earlier, after the clinical trial results become available and the database is locked) and the Assessment Aid Pilot Project (used by sponsors to organize their submission into a structured format to facilitate FDA’s review of the application). FDA Commissioner Gottlieb says, “With today’s approval, FDA used these approaches to allow the review team to start analyzing data before the submission of the application and help guide sponsor’s analysis of the top-line data.” Looking for a heavyweight fight? Watch sales of Pfizer Ibrance vs. Novartis Kisqali.
Pfizer announced price increases on about 40 drugs at the beginning of July. But after discussions with President Donald Trump and Health & Human Services Secretary Alex Azar, they’ve decided to cut-it-out. Trump had lambasted drug companies earlier in the week for price increases, noting that other markets like Europe get lower prices. After their meeting, Pfizer decided to roll-back the increases to pre-July figures, “to give the president an opportunity to work on his blueprint to strengthen the healthcare system and provide more access for patients.” And they’re leaving the price drops announced at the beginning of the month intact. The hikes aren’t completely gone though, Pfizer’s just holding off until 2019 or until that aforementioned blueprint takes effect. For a (pink) blueprint you don’t have to wait for, click here.
Novartis recently launched an app that enables patients taking part in ophthalmic clinical trials to self-report data, which could potentially speed the development of new therapies. Here’s lookin’ at you kid. According to a wonderful report from Deloitte, “the number of apps produced by pharma more than tripled from 2013 to 2016, but the year-over-year growth rate of downloads slowed from 197% between 2013 and 2014 to just 5% between 2015 and 2016.” Maybe pharma lies outside the circle of trust? The Deloitte report also states, “pharma apps are trusted by 32% of consumers, compared to 76% for apps developed by patient communities.” Look for more pharma-association collaborations like the Quitter’s Circle from Pfizer and the American Lung Association. Is it better that the Novartis app is for clinical trials? Hear InsightCity’s take on this article with this short podcast. (It’s our first one. We’re not pros. Don’t be mean.)
Order now and we’ll ship you the Thighmaster…and if you’re not satisfied, just return it within 14 days for a full refund. Money-back guarantees are almost a necessity for TV products, but what about for medications? Certainly not the norm, there have been some value-based contracts popping up in the pharma world. There’s a very interesting Forbes article written by former Pfizer global R&D President John LaMattina that lobbies for two major trade organizations (BIO and PhRMA) to pass resolutions that money-back guarantees become a formal practice with member companies. Wow, that would Shake Weight things up. LaMattina points to Amgen’s Repatha (LDL-C lowering) and Novartis’ new gene therapy Kymriah (CAR-T therapy), priced at $475,000/patient. Keep this on your radar, few things could change the healthcare landscape like widespread adoption of value-based pricing.
Just ask Pfizer. This week Pfizer ran into a couple “issues” surrounding drug manufacturing. Ok, to be honest, Tris Pharm—a CMO—was issued the FDA warning letter, but it was for a Pfizer ADHD product (Quillivant XR) and Pfizer was named in the FDA letter. This is also not just an issue for Pfizer, but for patients. For example, 6.1% of American children are on ADHD medication. To add insult to injury, Quillivant was recently listed as a drug that is in short supply. Our advice, stock up on Quillivant. Also this week, the FDA released a Complete Response Letter (CRL) for the company’s proposed trastuzumab biosimilar. Using normal words; no soup for you as the FDA highlighted the need for additional technical information and does not relate to safety or clinical data submitted in the application. Hopefully next week will be better.
Last week Pfizer announced they’re shuttering their neuroscience discovery unit, which dedicates resources to the discovery and development of drugs for both Alzheimer’s and Parkinson’s diseases. While the practical and macro implications of the drug giant’s decision may be minimal—don’t forget, more than 99% of these drugs fail before they get to market—seeing a leader “give up” the search will take the wind out of some sails. Especially for patients and advocacy groups. Pfizer appears to be setting itself up for a “buy” rather than “build” strategy, as they are starting a “neuroscience venture fund,” presumably to snatch up products discovered by the many start-ups who will continue to dig for neuroscience gold.