FUDiabetes

Relief for rising insulin prices on the horizon?

https://www.biocentury.com/bc-extra/politics-policy/2018-12-11/fda-biosimilars-policies-will-bring-interchangeable-insulin-

Cut & paste here if you’re too lazy to click (bold added by me for emphasis):

New FDA policies will lead to approvals of interchangeable insulin products that can be automatically substituted for branded insulin, FDA Commissioner Scott Gottlieb said Tuesday.

Gottlieb made the prediction in a statement about new guidance documents that outline how FDA will implement a law requiring that it stop regulating certain biologics, such as insulin and human growth hormone, as drugs. Under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), biologics that have been approved under NDAs will be deemed on March 23, 2020, to be approved under BLAs.

The quirk in U.S. law that has regulated insulin under NDAs has limited competition because it has been difficult to satisfy FDA’s requirements for a generic drug. The first biosimilar insulin was approved by EMA in 2014.

“Given our long experience regulating insulin products, and high interest among sponsors who are proposing to develop interchangeable insulins, we’re confident that interchangeable insulins – insulins that will be available for automatic substitution at the pharmacy level – will be attainable after the transition to deemed BLAs in March 2020,” Gottlieb said.

Gottlieb called the transition from NDA to BLA a “watershed moment for insulin products,” one that will create competition that will dramatically reduce prices and increase access.

The introduction of interchangeable insulins, Gottlieb said, will disrupt a pricing system that has led to an upward spiral of list prices for insulin that are linked to ever-higher rebates that the three manufacturers who dominate the U.S. market pay to PBMs to jockey for preferred status on formularies. Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO), Eli Lilly and Co. (NYSE:LLY) and Sanofi (NYSE:SNY) sell almost all insulin used in the U.S.

FDA is implementing the transition of NDAs for biologic into BLAs in ways that are intended to promote competition, Gottlieb said.

For example, drugs that transition to BLAs will not be eligible for the 12 years of market exclusivity that is available to newly licensed biologics.

FDA also announced that supplements to approved NDAs of biologics that are pending on March 23, 2020, will be administratively converted into BLA supplements.

The agency has approved at least two insulin products under section 505(b)(2), a regulation that allows follow-on drugs to reference safety and efficacy data of approved drugs. The agency granted 505(b)(2) approval to Sanofi’s Admelog Humalog insulin lispro in December 2017 and to Lilly’s Basaglar insulin glargine in December 2015. In July 2017, FDA granted tentative 505(b)(2) approval to Merck & Co. Inc. (NYSE:MRK) for Lusduna insulin glargine pending the outcome of a patent infringement suit brought by Sanofi, but Merck terminated its commercialization deal with Samsung Bioepis Co. Ltd. for Lusduna in October of this year.

Unlike biosimilars that are designated as interchangeable, 505(b)(2) drugs cannot be automatically substituted by pharmacists.

FDA issued a complete response letter in June to a 505(b)(2) application from Mylan N.V. (NASDAQ:MYL) and partner Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) for a follow-on version of Lantus insulin glargine. At the time, Mylan said it expected the CRL as it agreed to provide FDA additional data to support a manufacturing site change. The product has been approved as a biosimilar in Europe and Australia. Mylan has told BioCentury it plans to launch the product in the U.S. in 2020.

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Mylan has apparently successfully defended itself against patent infringement claims from sanofi over a Lantus like product:. Mylan PR

I think if the pharmacist gave me admelog and basaglar in place of Novolog and Tresiba, I might be inclined to tell him to shove it where the sun don’t shine.

The FDA is nothing more than beauracrats acting like beauracrats. If they want to lower insulin prices, then pass a law making it illegal to give a rebate to anyone but a drug consumer. But that would take some cajones, something that powerful people seem to lack.

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A lot of other people feel the same way… which is part of what’s allowed the costs to run wild… I think generic insulins are necessary—-

I don’t consider amdelog or basaglar to be true “generics” in the meaningful sense of the word since they are still manufactured and their price set by the big 3… and therefore don’t generate any downward price pressure

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Basaglar generated a heck of a lot of downward price pressure for me - my insurance gave me a full year of it for free to switch from Lantus (which my copayment would have gone up for if I hadn’t switched).

I agree!

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Yes, sure, individual patients may have discounts and incentives to switch etc, but I’m talking about on the macro scale… the big 3 will just keep raising the price of their new pretend “generic” right along with the others

I do agree that Basaglar isn’t a true generic and has limited price relief, but that’s what so encouraging about this article- the FDA is changing how they regulate insulin to break this oligopoly. No longer will manufacturers need a full NDA (new drug application) to market insulin, but only a BLA (Biologic License Application) similar to how other generic drugs are approved. Other companies (i.e. not the big 3) will more easily be able to market competing product to hopefully drive down prices.

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@Sam is right. Going after the Big Three, or making it slightly easier for biosimilars and generics of insulin to be marketed, is not going to come near giving the necessary relief. That only nibbles around the real problem.

The real problem is in distribution, which is controlled ultimately by the PBM’s. They must be dragged into moral compliance by disabling their gravy train. And it can be easily done by making it illegal for rebates anywhere in the drug supply chain except to the end consumer.

The problem is that our legislators would not do that to the PBM’S because of the perks that are provided to them by the PBM’s. In our government money talks.

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I think the pbm issue is a huge piece of the puzzle, but I also think making it possible for smaller players to produce biosimilars and make a profit is also key to introducing some competition in the market.

Not only for price, but for accessibility and incentive for innovation… How many of us are going off formulary to get an insulin we like more? Very near zero. We allow it to be dictated to us by our insurance what is available to us and at what price— because as a consumer group we have collectively decided that we can’t afford our drugs on our own that we need to survive. That is a huge problem. It puts us at the absolute mercy of insurers, and pharma. The only way to break that part of the cycle is low cost alternatives that work equally well. That’s why I welcome opening the door to true generics and biosimilars.

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That press release I listed earlier suggests mylan is getting into insulin, at least another larger player is getting into the game, fwiw.

I don’t play the insurance games when buying insulin. Pay cash where insulin may be had cheaply, and the formulary games are avoided altogether,

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I agree with that wholeheartedly, but the majority of customers can’t even comprehend that it’s possible even if they can afford to do so—which many can not—hence the virtual stranglehold the majority of diabetics perceive…

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Yeah you’re right Sam, that is just a coping strategy.

Insurance should’ve never been involved in prescriptions in the first place, especially routine ones.

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