Bring on the biosimilars

Maybe when we write about the top stories of 2019, we might be calling it “The Year of the Biosimilar” –  or not. In a recent press release by FDA Commissioner Scott Gottlieb, he states; “We’ve set out in recent months to advance new policies that are aimed at promoting more competition when it comes to biosimilar products. In 2019, we plan to take some additional new steps to promote these goals. We’re now going to be focusing equal attention to potentially anti-competitive practices when it comes to biosimilar drugs.” Sounds like there’s a new sheriff in town. One of the first targets might be the insulin producers. According to Dr. Gottlieb, “There are currently no approved insulin products that can be substituted at the pharmacy level.” Let’s see if Dr. Gottlieb will have the same success as Sheriff Rick Grimes. Good luck Dr. G and shoot straight.

Gottlieb: “we’re not going to play regulatory whack-a-mole”

In last week’s He said, she said InsightCity article we talked about how regulators in Britain don’t think the price of biosimilar products is low enough. FDA Commissioner Scott Gottlieb has kicked it up a bit. In prepared remarks, Gottlieb blasts the pharma industry. Some quotes: “the FDA approved 11 biosimilars, only 3 are marketed in the U.S.” – “competition is, for the most part, anemic.” – “if Americans had the opportunity to purchase successfully marketed, FDA-approved biosimilar prescription drugs, they could have saved more than $4.5 billion in 2017.” – “branded drug makers thwart competition by dangling big rebates to lock up payors in multi-year contracts right on the eve of biosimilar entry.” All this was part of FDA releasing their Biosimilars Action Plan and the final guidance on biosimilar labeling. Might be time to keep your head down.

Do you take drugs Danny? Everyday.

Apparently so does everyone else. For a video presentation of the top 20 selling drugs for 2017, see this. Warning, the presentation is titled “best selling drugs in 2018.” See the disconnect? While InsightCity does not have Carnac skills, others might. Anywho. Drug #20 (Stelara) generated ~$4B in sales while #1 (Humira) generated ~$18B. Not too shabby. What’s really interesting is that Humira is off-patent and the FDA has approved two, yes two, biosimilars. How has AbbVie continued to increase sales of Humira after patent expiration? In a word, legalese. According to Jefferies analyst Ian Hilliker, “the fact that a 2nd biosimilar developer has given up on litigating Humira in favour of a settlement helps to underpin the strength of AbbVie’s Humira IP.” With a worldwide prescription drug market of ~$800B, it’s not only Danny Noonan that takes drugs every day.

Why you gotta be so mean?

Yes, that’s a TSwift “Mean” reference. Not saying we’re proud of it and not saying we’re not. Speaking of mean, FDA Commissioner Scott Gottlieb was mean this week. Using phrases like “rigged payment scheme” and “team up with payors” and “insidious barrier” Gottlieb took aim at PBMs, distributors, drug stores and pharmaceutical companies talking about how these entities “effectively split monopoly rents” instead of passing on savings to consumers. These comments came during a speech where he pointed out that 9 biosimilars have been approved by the FDA and only 3 are for sale. (see InsightCity’s Biosimilar HealthyDose) You’ll be shocked to know that the insurance companies blame the pharma companies and the PBMs blamed the insurance companies. Perfect. BTW, Europe has seen drug prices fall as much as 60% with the introduction of biosimilars. Not too shabby.

Big changes for your RA, maybe

And no, we are not talking about the person that let you drink in your college dorm room. Earlier this week Boehringer Ingelheim announced the FDA has approved Cyltezo, a biosimilar to AbbVie’s Humira. A year ago, the FDA approved Amgen’s Amjevita, another biosimilar to Humira. Cyzelto was noted to be “highly-similar” to the reference product. Good for BI. The FDA said that Amjevita is not an interchangeable product for Humira and placed a Black Box warning on the product. Bad for Amgen. But wait, there’re more. It really doesn’t matter. AbbVie has launched several lawsuits, so despite the FDA’s approval, neither Cyltezo nor Amjevita are commercially available in the US. Here is what Amgen and BI are thinking now. Oh, what a tangled web we weave…

Come on down, the price is right

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.