On Feb. 9, CreakyJoints will represent patients in public comments before the Food and Drug Administration Arthritis Advisory Committee meeting. We’ll be talking about biosimilars, and a lot of people, including patients, have good reasons to, and will try to, influence the outcome. So will we.

Drugs called biologics have been around for 33 years, long enough for us to know what happens when you inject or infuse them. These biologics are variations of living proteins that are specifically made, or programmed, to counteract disease. They are different from many traditional pills in that they target the causes of disease rather than treating just the symptoms. They are effective against diabetes, cancer, autoimmune conditions like rheumatoid arthritis, multiple sclerosis, Crohn’s disease and other conditions.

Having lived through life before and during the latest round of biologics — in the front row as a health advocate, co-founder of the arthritis community CreakyJoints.org, and an arthritis patient, although not on biologics — I am especially aware of how game-changing these biologics are. Think wheelchairs-to-tennis courts. Or from doubled-over-on-disability to back-to-work and thriving. Countless people have experienced these breakthroughs and countless more will.

Because biologics have been around long enough to halt and reverse progression of disease, it also means that they have been around long enough to fall off what’s known as a “patent cliff.” Other companies can now copy or replicate the newer formulas, and they’re permitted to manufacture similar forms of the same medicine. It’s similar, not identical, because these are complex, living cells, and that means they can’t be exactly replicated pills like acetaminophen (Tylenol) or atorvastatin (Lipitor) can.

That is why biologics can’t be made generically or called generics. The new version of a biologic is called a “biosimilar.”

Stay with me. Here comes the juicy bit.

The FDA hasn’t established rules and regulations about whether a company making a biosimilar needs to complete the same studies to make sure it’s safe and works like the original drug.

I think the FDA is overwhelmed, partially because of the complexity of the issues requiring guidance, and also because any rules impacting $79 billion worth of product per year in the U.S. in 2015, has drawn the attention of more than a few interested parties with specific business objectives that can be reached within an FDA ruling. So the decision not to make a decision yet is one you can’t blame them for, even though they’ve had about six years to do it. But the FDA must start making decisions about biosimilars. The patents on the biologics are expiring.

Filgrastim, a biologic to treat radiation therapy-induced anemia, was approved by the FDA as a biosimilar in 2015. This was the tip of the biosimilar iceberg, because others are coming, and many are far more complex, and require additional approval considerations. Some of these biosimliars are like the next one up for consideration by the FDA on Feb. 9th, Infliximab. The drug it copies, Remicade, has been approved by the FDA to treat inflammation of the gut, joints and skin. So manufacturers, in this case a South Korean company called Celltrion, are hoping the FDA will approve its biosimilar for the same conditions as the biologic it copies — without additional clinical trials. This is called indication extrapolation.

That’s a big deal because theoretically, lots of money and time is saved by avoiding clinical trials that would normally be required of a new drug. This is one reason why many experts say biosimilars will be less expensive than the original biologics. Estimates range from 15 to 35 percent less, but it’s anybody’s guess.

If you believe a biosimilar is close enough to the original biologic, then you probably think clinical trials aren’t necessary.

So now we’re at a point where these rules need to be written in real time, and it’s about to get interesting because precedent set by early rulings will impact dozens of other biosimilars coming to market.

And there are many rules to be written:

— Safety, which is often discussed with indication extrapolation. Do biosimilars need clinical trials in order to be prescribed for all the conditions of the drug they copy?

— Naming. Should biosimilars use the same name as the biologic they copy?

— Interchangeability. An FDA ruling that allows one drug to be switched for another since it’s accepted as interchangeable.

— Labeling. Does the biosimilar’s label have to represent the safety and clinical trial data for itself? Or can the biosimilar’s label borrow information from the original biologic? Does the original biologic name need to be shown?

— Cost savings. Do biosimilar savings go to the patient or an insurance company’s bottom line?

There’s irony here. Patients take these drugs, but aren’t often in the room when these decisions are being made. Our public comments on Feb. 9 will help the patient’s voice get heard.

For the public to have confidence in biosimilars, we need reassurance that safety is measured accurately, names have functionality that ensure easy identification, swift tracking and tracing, and these days, as important, that cost savings are passed down to the patients who are paying the insurance premiums, copays and deductibles.

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Biosimilar Drugs: the Promise of Great Science and Great Pricing Gets Closer to Reality originally appeared on usnews.com