Friday, March 16, 2007

FDA Indicates Biotech Knockoffs Might Have Different Status Than "Generics"

Pharmacy benefits managers would not be able to simply subsitute generic biopharmaceuticals for the brand-name products without consent.

Continuing my ongoing coverage on this topic (including my original post, a follow-up based on NYT coverage, recent news that legislators have finally introduced a bill that would enable the FDA to approve generic biopharmaceuticals, and my post on the Express Scripts study that suggested that generic insulin could save $797+ million in the first year, and in excess of $16 billion over 10 years), today's Associated Press featured an article that I think should address anyone's remaining concerns about opening the door to generic biopharmaceuticals (or as the FDA prefers to call them, "follow-on" protein products) such as insulin. Its important to note that the pending legislation would enable the FDA to require additional clinical trial results if the agency feels they are necessary to approve a generic biopharmaceutical.

But by classifying follow-on protein products as something other than generics, the FDA is indicating that generic biopharmaceuticals would not exactly be considered generics, which are identical, or bioequivalent to the brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use and are therefore interchangable with the brand name. Instead, follow-on protein medicines would be considered similar enough to be used in place of a brand-name, but not quite interchangable. The bottom line is that pharmacists would not be able to subsitute a cheaper generic version without telling you. This is basically the situation with insulin today. Sure, Humalog, Novolog and Apidra are rapid-acting analogs, but a patient cannot necessarily switch from one brand to another without making adjustments. I think the Associated Press calling them a "lower" status than a generic is a misnomer, rather it would be a different status than a generic, meaning it can be used to treat the same condition, just not interchangably with the brand-name version -- adjustments might need to be made. This would provide patients with access to lower-cost insulin, but would not force them to switch simply because their healthcare provider wants you to take the cheaper version.

For more complete details on this subject, please see the article that follows, as well as the links above.

FDA: Biotech Knockoffs Earn Lower Status
By Andrew Bridges, Associated Press
March 15, 2007

WASHINGTON -- Copycat versions of pricey biotech drugs may be relegated to a status below that of generic versions of traditional chemical drugs, the head of the Food and Drug Administration suggested Thursday.

Dr. Andrew von Eschenbach told pharmaceutical executives that such knockoffs would be considered only "similar" to brand-name drugs. The FDA commissioner later told The Associated Press that would mean knockoffs would not be interchangeable, or able to be substituted.

That definition mirrors one used by the European Medicines Agency, the FDA's European counterpart. It would draw a distinction between biotech knockoffs, which the FDA says it still lacks the legal and scientific frameworks to approve, and the generic versions of traditional drugs already available.

Today, traditional drug knockoffs or generics are identical to their brand-name versions and can be swapped or substituted for one another. That would not be the case with a knockoff biotech drug deemed only "similar," even though its effect on patients would be the same.

"We recognize that the end point would be what could be best described as similarity. Similarity in the sense that when a doctor gives you the product -- delivered it to a patient -- it will achieve an effect that is similar to the effect that we expected from the innovative ... compound," von Eschenbach told the annual meeting of the Pharmaceutical Research and Manufacturers of America, the drug industry group.

Unlike traditional chemical-based drugs, biotech drugs -- also called biologics or biopharmaceuticals -- are made from proteins taken from living cells. Generally, biotech drugs are far more costly and complex than traditional drugs to both make and copy.

Because of that complexity, the FDA and the brand-name drug industry both maintain it would be difficult to ensure the safety and effectiveness of the knockoffs, sometimes called follow-on protein products.

A bipartisan group of lawmakers recently renewed the push to give the agency that legal authority. The FDA says it continues to develop the scientific guidelines required to consider applications from would-be manufactures of the copycat biotech drugs.

The Generic Pharmaceutical Association says the FDA already has the scientific knowledge to approve knockoffs, just as it now can sign off on the changes made by brand-name biotech companies in how they produce their drugs.

"The commissioner is acknowledging that when brands make changes to their products, they are no longer identical to the approved product, but FDA follows sound science to review and approve these changes. This same sound science will be used to review biogenerics for safety and efficacy," said Kathleen Jaeger, the generic drug industry group's president and chief executive officer.

This article originally appeared at:


BetterCell said...

By flooding Generics unto the Marketplace, Insurance Agencies as well as Medicare will eventual force people to use "their recommended products" rather than give freedom of choice as regards the purchase and availability of needed medications. This is always what occurs when there is too much Government involvement with anything. It is not always to the patient's benefit, but more with the bottom line, how much $$ can we save which again is not always in the patient's best interest. I want Freedom of Choice. Unfortunately, very few people know that there is a difference in quality control and bioavailability regarding Generics and Brand Name Pharmaceuticals.

Scott S said...

But by not referring to them as equivalent, the FDA is acknowledging that these would not be exactly the same. Today, managed care does something similar in that they have "preferred" medicines, while nonpreferred meds may carry a different price tag. They are not calling them bioequivalent, which is an acknowledgement that they cannot call them interchangable.

Bernard said...


Thanks for keeping me so informed on this slow process.

Sometimes the speed at which the FDA moves just infuriates me.

I'm curious. Have you found some within the FDA who can be contacted for more information? Is there any public meeting about this in the future?

I testified in front of the FDA when they were having the approval meeting for Humalog. And I think I'd be interested in doing again if it happened for something like the issue you're researching.

What really helped me at that time was establishing a contact within the FDA. That was many years ago, otherwise I might still have that name.

Scott S said...

Although I'm not completely certain, I believe most of the public hearings on this subject were done in 2005 (a quick search of the FDA's website shows testimony, presentations and other documents from BIO, GPhA, not to mention companies including Pfizer, Teva, Barr Pharmaceuticals and others).

While the FDA arguably has everything they need to move on the issue, the Agency's leadership has been unwilling to move on the issue, instead saying that Congress needs to pass laws to move ahead on the issue. The pharmaceutical industry was among the biggest contributors to major Republican Congressional candidates, and the underlying assumption was that they did not need to fear any legislation that would threaten their perpetual monopolies.

But then came Congressional passage of the Medicare Prescription Drug Benefit which meant the Federal government suddenly had to pay for all these drugs, followed by the Jack Abramoff lobbyist scandal, capped by last year's Democratic victories, and suddenly, the issue is on the table again.

I'm not sure how much more public input will be asked for on the issue, but I suspect if passed, the FDA will have some work to do on this issue and could seek more input. I'll see if I can find any names, in the interim, I would suggest contacting your Congressional representatives to express your support for the bill and above all, tell them why. They tend to react much better when there is a personal story attached!