• Do you have any victories you'd like to share for the month of May? Help us celebrate others by posting here.

Medicare Prescription Payment Plan

For approval, the manufacturer of a generic drug must demonstrate, among other things, that the generic is bioequivalent to the brand-name drug. By contrast, biosimilar manufacturers must demonstrate that the biosimilar is highly similar to the reference product, except for minor differences in clinically inactive components. Biosimilar manufacturers must also demonstrate that there are no clinically meaningful differences between the biosimilar and the reference product in terms of the safety, purity, and potency of the product (i.e., safety and effectiveness).



Mom (or maybe the straight guy lol) can put this in English for the mere humans on the forum.

My understanding is the prescribing doc must write the Rx for the biosimilar. Pharmacy is not allowed to substitute.
I call him Boy George
 
For approval, the manufacturer of a generic drug must demonstrate, among other things, that the generic is bioequivalent to the brand-name drug. By contrast, biosimilar manufacturers must demonstrate that the biosimilar is highly similar to the reference product, except for minor differences in clinically inactive components. Biosimilar manufacturers must also demonstrate that there are no clinically meaningful differences between the biosimilar and the reference product in terms of the safety, purity, and potency of the product (i.e., safety and effectiveness).



Mom (or maybe the straight guy lol) can put this in English for the mere humans on the forum.

My understanding is the prescribing doc must write the Rx for the biosimilar. Pharmacy is not allowed to substitute.

No I understand that. But as we all know, some people just don't respond well to "generic" medications. That's why I mentioned the efficacy.
 
some people just don't respond well to "generic" medications

True, but a biosimilar is closer to the "brand" than any generic.

And if it isn't right for them they can switch back.



Many studies have looked at the safety of switching to a biosimilar from a reference drug. None have found any differences in safety, efficacy or the ability of a drug to trigger an unwanted immune response. The same holds true for studies focused specifically on adalimumab. A 2022 review of 21 studies involving nearly 3,000 patients found no difference in safety or effectiveness when switching from Humira to eight different biosimilars.


More information in that article including patient reluctance to switching.
 
True, but a biosimilar is closer to the "brand" than any generic.

And if it isn't right for them they can switch back.



Many studies have looked at the safety of switching to a biosimilar from a reference drug. None have found any differences in safety, efficacy or the ability of a drug to trigger an unwanted immune response. The same holds true for studies focused specifically on adalimumab. A 2022 review of 21 studies involving nearly 3,000 patients found no difference in safety or effectiveness when switching from Humira to eight different biosimilars.


More information in that article including patient reluctance to switching.

While anecdotal, I've read posts from people who switched from Humira to a biosimilar and had flare ups from their conditions come back. What can never be proven is whether it was a result of the switch or not.
 
I'm not happy with the wording in the rule. "Automatic switching at the pharmacy". And its not like these people aren't sick. These are last resort drugs when nothing else had helped an autoimmune disease. That's why I wanted the list of approved biosimilars (Thanks, Somarco!), so I can get out in front of it with clients.
 
Automatic switching at the pharmacy"

I didn't think that was allowed with biologics/biosimilars.

These are last resort drugs when nothing else had helped an autoimmune disease.

When a drug is approved by the FDA, it may seem like it's only a matter of time before some unexpected side effects are discovered. Perhaps it seems that way because it's true! A 2017 study of drugs approved within a 10-year period found that the FDA announced alerts, warnings, or recalls on about one-third of them in the years after their approval.

Some of the side effects were minor and easily managed. For example, there might be a warning to avoid taking a new medication at the same time as another medication. But sometimes the "side effect" is death. That was the case when the FDA issued a warning about the gout drug febuxostat (Uloric) in 2019.
 
Asked the legislative person for HCSC today if she had any insight on the rule changes for Biosimilar Drugs. Crickets. And then “all of Part D is in chaos for 2025. Get ready”

Ummm…ok
 
Back
Top