Biosimilar availability in usa (inflectra and Amjevita)

Anybody hear anything new about availability or gotten these? There now appears to be two biosimilars approved for use in the USA. A biosimilar is as close as you get for a generic, when you're talking biologics, and they're supposed to be about 20 percent cheaper than the original.

Inflectra is a biosimilar to remicade.

Amjevita is a biosimilar to humira. ibdnewstoday.com/2016/09/27/fda-approves-new-biosimilar-amjevita-for-multiple-inflammatory-diseases-drug-information-update/

I'm a big fan of cheaper alternatives. I believe they're used within the UK.

Verucasalt2.0 said...
Lol, before I got bounced out, some idiot tried to tell me if big government regulation would get out of the way, Abbvie would be more free to offer Humira cheaper. Right, that's it, that's why it cost so much. Oy vey.

He might not have been that big of an idiot. The FDA requires companies to spend billions of dollars to prove both safety and effectiveness. I think everyone agrees that the FDA should have to approve new drugs for safety, but you could make the argument that doctors and medical groups are perfectly capable of reading the research on effectiveness and making their own prescribing decisions based on their patients best interests. That would get the drugs to market much faster and at a much lower cost, and give the company a chance to start making back their investment years sooner.

Thousands of people with terminal illnesses die every year waiting for the FDA to approve drugs for their conditions for effectiveness. How cruel and stupid is that? These people are dying.

There are currently over 4,000 generic drugs awaiting approval by the FDA. The process takes years and is very costly. The EpiPen, recently in the news for it's outrageous price increases, has at least one generic from a major company stuck in the queue. If that generic were available the EpiPen would be far, far less expensive. It costs about $20 to make. After the last price increase Mylan was selling them for $300 each.

www.npr.org/sections/health-shots/2016/09/01/492235796/fda-fees-on-industry-havent-fixed-delays-in-generic-drug-approvals

The FDA does not serve the American public well at all.

Post Edited (Richard in NY) : 10/4/2016 7:26:19 AM (GMT-6)

Verucasalt2.0 said...
Would I trust drug companies to police themselves to ensure their drugs are safe to take?

Not only NO but F&$k NO.

You didn't read my post carefully. I wouldn't trust them to ensure safety either. That's why I said " I think everyone agrees that the FDA should have to approve new drugs for safety,"

If a drug is proven safe, why not let doctors decide if it's effective enough to be worth trying? If your child was dying of cancer and a drug that was proven safe had a 10% chance of extending her life by a year, shouldn't you have the option of trying it?

Verucasalt2.0 said...
I see doctors who work for drug companies the same way I see scientists who work for big energy companies, not entirely trustworthy or without bias. They're in the tank because of where their bread is buttered. And I don't think it would be safe or responsible to let doctors prescribe unproven drugs at their say so, unless it's a clinical trial or supervised experimental situation. There has to be oversight.

I'm not referring to letting doctors who work for drug companies decide to prescribe something. I'm referring to individual doctors in clinical practice deciding what drugs to prescribe for people under their care whether it's FDA approved for that condition or not. It happens already once a drug is on the market. It's called prescribing "off label".

www.webmd.com/a-to-z-guides/features/off-label-drug-use-what-you-need-to-know#1

The next time your doctor writes you a prescription, consider this: The medication may not be approved for your specific condition or age group.

But you probably shouldn't call the medical board. The practice, called "off-label" prescribing, is entirely legal and very common. More than one in five outpatient prescriptions written in the U.S. are for off-label therapies.

"Off-label" means the medication is being used in a manner not specified in the FDA's approved packaging label, or insert. Every prescription drug marketed in the U.S. carries an individual, FDA-approved label. This label is a written report that provides detailed instructions regarding the approved uses and doses, which are based on the results of clinical studies that the drug maker submitted to the FDA.

“Many people may be surprised to know that the FDA regulates drug approval, not drug prescribing, and ... doctors are free to prescribe a drug for any [reason they think is medically appropriate],” says G. Caleb Alexander, MD, MS, a medical ethics advocate and assistant professor of medicine at the University of Chicago Medical Center. "Off-label use is so common, that virtually every drug is used off-label in some circumstances."

*********

Would you consider this a dangerous lack of oversight?

Verucasalt2.0 said...
Fast tracking drugs through the FDA, letting doctors decide does nothing to costs anyway, so I'm finding your point irrelevant. Drug companies have a vested interest in getting drugs through the FDA and it ain't to provide them cheaper to patients. Drugs are approved at a much faster rate these days but if it's not a drug that will be used widespread, say like Humira, then a drug company has no interest.

What makes you think that drugs are approved at a "much faster rate these days"? According to the FDA the NDA (new drug approval) process takes between 7.6 and 19 years:

www.fdareview.org/03_drug_development.php

Did it used to take much longer? I think that the pharmas would like to see all of their applications go through a few years faster, regardless of the potential market size. If the drug wasn't commercially viable they wouldn't have developed it.

Verucasalt2.0 said...
And the issue with generics is are they as effective? Are the ingredients the same? Is the manufacturing process up to standards? Would I want to find out the hard way they aren't? Not really.

Generics should absolutely have to go through an approval process. I never suggested otherwise. Reread my original post a little more carefully. My issue is with the huge backlog and lengthy process the FDA has in place. This is from the NPR article I linked to earlier:

As of July 1, the FDA had 4,036 generic drug applications awaiting approval, and the median time it takes for the FDA to approve a generic is now 47 months, according to the Generic Pharmaceutical Association, a trade group. The FDA has approved more generics in the past few years, but a flood of applications has added to the problem.

By comparison, the European Medicines Agency, Europe's version of the FDA, has just 24 generics, including biologically based biosimilars awaiting approval. The FDA's generic count doesn't include biosimilars, which are more complicated medicines to review. The EMA along with the European Commission, which handles approval of marketing materials, are approving generics and brand-name drugs in about a year on average, according to the EMA.

Critics say getting generic alternatives to the U.S. market for products like EpiPen is still taking far too long. Other off-patent drugs with rising prices and no generic competition have also drawn scrutiny, including Turing Pharmaceuticals' Daraprim, for toxoplasmosis, and Valeant's cardiovascular drugs Isuprel and Nitropress.

*****************

So somehow the European equivalent of the FDA manages to do this with essentially no backlog (24 applications waiting vs over 4,000) , and in the US it's a 4 year wait. That means that Europeans are paying generic prices for thousands of medications that have lost patent protection while we're stuck paying monopoly pricing for the brand name version.

As I said, this does not serve the American people well.