Conversation of the Week: Experiences with Biosimilars
The first injectable Biosimilar medication will come to market in January of 2023. Amjevita, a biosimilar of Humira, will likely be the first similar product in the marketplace in the United States.
For those who have followed the twisted road of the Biosimilar introduction, the release of Amjevita (produced by Amgen) is the culmination of over six years of struggle. After the legal maneuvering, the various delays, and finally a settlement. Today we know of six potential biosimilars of Humira coming to market in 2023. Also, one interchangeable Humira medication may be coming to market in mid-2023.
This week I hope we can discuss the coming of Biosimilar medications and what you may know and want to know.
Questions like:
Will I be required to switch for cost purposes?
Are Biosimilars generic medications?
What is the difference between a Reference, Biosimilar, and Bio interchangeable medication?
Are my doctors aware of the Biosimilar market?
Will Biosimilars save money?
If you have already already had a Biosimilar medication for RA, what is changing next year?
These and many more questions have been racing around the patient community since at least 2015.
While I may not know all the answers, I am willing to share what I have learned studying this issue over the last seven years. I have spoken on podcasts and panels about Biosimilars and was recently included on a panel of patients and doctors discussing the transition process.
So please bring your questions, and let's learn about this topic together.
Hi
. I'll help get the conversation started. How about an easy one (he says hoping you won't reach through the screen to throttle me after reading). So what is the story with biosimilars for Enbrel? I know Erelzi received FDA approval all the way back in August of 2016. I also know that there have been quite a few court decisions and a lot of negotiations. I haven't followed too closely (Kelly hasn't used Enbrel in many years), but I remember seeing something about a decision keeping any Enbrel biosimilar off the market until 2029. Is that about it or is there potentially more to the story? Plus, will the international market for these drugs make any difference? Thanks. Richard (RheumatoidArthritis.net Team) Ahh, Richard, you ask the multi-billion dollar question. Here is the simple answer, then I will let you know why. Get ready; the answer is that we can expect a Biosimilar in the US market in approximately 2029 or 2030.
OK, now that the shock is sinking in, here is why. The FDA approved the Biosimilar Erelzi in August of 2016, and most of us thought it would likely be the first to market in the US. It is currently available in Canada and most of the rest of the world. So 2029?
The answer lay with US patent law and the aggressive defense of the Amgen patent.
Novartis manufactures Erelzi. However Samsung and perhaps Pfizer may have an Enbrel Biosimilar as well. In August 2019, a federal district court in NJ upheld the rights of Amgen's patents. In July 2020, a federal appeals court upheld the lower court's decision in a split decision. Then in May 2021, the Federal Supreme court chose not to take up the case, meaning the lower court decision was upheld.
This link will give an excellent overview of how Amgen has "innovated" Enbriel to build a virtual picket fence around the medication to keep it from being used as a Biosimilar. Here is a good summary of this path to getting here:
https://www.biopharmadive.com/news/amgen-enbrel-patent-thicket-monopoly-biosimilar/609042/
This brings us to the question might it come to market sooner? The good news is, perhaps, but no time soon. Enbrel has produced around 70 Billion dollars of revenue since its introduction. Some experts think a licensing deal might come sooner. But the rumor is that purchasing that license might cost as much as several billion dollars each year that might be taken off the 2029 time frame.
Yeah, it's a lot.
Some of us have already had a Biosimilar for treatment of RA in the US. Do you know if you have already? There are two methods of how this might have been done. The most likely method has occurred with infused medications. Remicaide and Rituxin are two of the mostly likely to have been substituted. For Remicaide the most common names that you may used are Inflectra, Renflexis, or Avsola. For Rituxin medciations names you may have heard of include RUXIENCE and Riabni.
The second way you may have been given a Biosimilar is if you participated in one of the many ongoing clinical trials. Short of those two methods if you are a resident of the US you could only obtain one of the Biosimilar products in a different country.
One of the significant issues in 2023, will be confusion over the terms reference product, Biosimilar and Biointerchangeable. the science is complicated but the at the end what patients need to know is that a reference product is the original branded product. So Humira is a reference product. Amjevita is a Biosimilar. But about July 2023 a product called Cyltezo manufactured by Boehringer Ingelheim is expected to come to market as a Biointerchanghable to Humira . This is an important distinction because at least as far as the FDA is concerned Cyltezo could be substituted without patent consent.
But the FDA is not the final word. Today many states have laws preventing a pharmacy from switching biologic medications without at least notifying the patient. However this is not every state and in many states the Biointerchangable label means the two medications can be used interchangeably. This has led to term nonmedical switching. In other words, the medication is changed for a reason that is not done to improve treatment. This makes those medications more like generics.
At present two other companies have applications pending before the FDA for Biointerchangable status of two more medications that if approved will compete with Humira. In addition Amgen has stated they will seek biointerchangable status for Cyltezo in 2023.OOPS what i mean to say is that Amgen has announced it intends to seek Biointerchangeable status for Amjevita later int he year. The names confuse me to no end.
Here is the note about these terms. Biosimilar requires less study for FDA designation (not a lesser medication) but less proof and clinical studies than a Biointerchangable. The real question is what must be studied to gain that designation.
It boils down to two things a Biointerchangable must show to be designated as such.
1. Patents have to demonstrate no significant loss of efficacy when switched back and forth between the proposed medication and the reference product.
2. It must be substantially equal to the structure of the reference medication.
When Biosimilars started to be approved in 2016, few thought the manufacturers would qualify as Biointerchangable. It was felt that the benefit of the additional work to prove Biointerchangable would not be worth the effort.
With the delay of the Biosimilar coming to market, the pressure was off the Biosimilar manufacturer to produce quick in-market results. As the FDA and industry further clarified what Biointerchangable might look like, manufacturers decided it would be in their best interest to seek the additional qualification. This has a lot to do with state laws governing nonmedical switching.
Today it is felt that most medications will come to market as both Biosimilar (a lower point for research) and Biointerchangable. If this trend continues past Humira is anyone's guess. But for now, we will see the next two to enter the market will be Biointerchangable. We also see that Amgen has announced that they will seek Biointerchangable status for the first to market Amjevita later this year.
I could never first or second guess the market intentions of Pharma. But it looks like in the US, Biointerchangable status is worth the additional work to obtain the designation.
