Healthy Skepticism Library item: 19581

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Publication type: news

Binning D
Proving cheaper drugs just as safe: Peter Simpson says the products his company makes are as good as the originals
The Australian 2011 May 7
http://www.theaustralian.com.au/news/health-science/proving-cheaper-drugs-just-as-safe-peter-simpson-says-the-products-his-company-makes-are-as-good-as-the-originals/story-e6frg8y6-1226050757438

Full text:

BACK in 2005, Australian biotech entrepreneur Peter Simpson noticed several of the world’s most expensive drugs were just a few years from patent expiry.

He founded a company, Biogenerics, to take advantage of the opportunity.

He knew these weren’t ordinary drugs. They belonged to a new class of medicines known as biologics.

Unlike most drugs, which are chemically derived, biologics are made using biological processes such as cultivation within living organisms. Biologics include a wide range of medicinal products such as vaccines, blood and blood components, allergenics, cells, gene therapies, tissues and recombinant therapeutic proteins.

Not only are biologics difficult and expensive to produce, they’re difficult to copy.

“When it became obvious that a large range of biological drugs were going to come off patent from about 2008 onwards, there was much confusion regarding what we [as an industry] would call them,” Simpson recalls.

“We couldn’t call them, or imply that they were, ‘generic’ drugs, as the population at large, including clinicians, perceived such drugs to be exactly equivalent.”

Regardless of what they’re called, Australians would welcome the opportunity to buy these medications at a fraction of the cost of the original, as they do with true generics.

But the Therapeutic Goods Administration is yet to put in place adequate regulations that would guarantee their efficacy.

About 10 months ago, the TGA and the Pharmaceutical Benefits Scheme released a draft paper on biosimilars, the equivalent of generics. Last December, the TGA recommended establishing a working group.

According to Andrew McLachlan, professor of pharmacy at the University of Sydney and Concord Hospital, there’s been virtually no progress and no communication. “I don’t understand why things have broken down.”

The TGA informs Weekend Health it has adopted “specific European guidelines to guide sponsors who submit biosimilar products for evaluation”.

The significance is that the drugs are called biosimilars in Europe while in the US they’re known as follow-on biologics.

The two jurisdictions have also followed different regulatory paths.

In the US, clinicians can choose between two different categories of FOBs: biosimilar and bio-interchangeable. As Simpson explains, the difference is critical.

“A biosimilar FOB has undergone a clinical trial program where the outcome of that study has demonstrated that the two drugs being tested [the FOB and the original drug] are likely to produce a similar clinical outcome.”

They’re similar but not interchangeable, says Simpson, noting an interchangeable FOB has undergone a more stringent clinical evaluation that applies a different type of clinical assessment.

“For this type of study the clinical outcome has been to prove that the clinician could, at the start of therapy, use either the FOB drug or the innovator drug and be assured that he or she would get the same clinical outcome,” he says.

In contrast, European regulators, and seemingly Australia’s, don’t recognise the distinction.

This has become a source of great concern among European physicians, many of whom are so worried about the effects of these biosimilars that they’re boycotting them altogether.

“Despite huge marketing campaigns in Europe, the uptake of biosimilar drugs has been woeful,” Simpson says.

The key concern with biologics is immunogenicity.

That is, as products are typically manufactured in living cells, the body recognises them as foreign, resulting in immune responses such as the release of microbe-fighting antibodies.

Immunogenicity can be influenced by factors such as manufacturing processes and impurities, which can alter the structure or properties of the drug.

“With biologic drugs, the way they’re made, there will always be slight differences,” Simpson says. “No two batches are going to be the same . . . It’s a very awkward fact for the industry.”

Meanwhile, back in the less perplexing world of chemically derived drugs, there’s mounting evidence that generic medications, too, may not always be as close to the originals as clinicians would like.

In the US, for instance, several generic products have come under scrutiny after widespread reports of adverse patient reactions. Among the drugs causing most concern are generic versions of the antidepressant and nicotine dependence drug Wellbutrin — sold here as Zyban, Prexaton, and Chlorprax — as well as generics of blood pressure and angina medication Toprol. Only the original drug Toprol is sold in Australia. In the worst cases, depressed people experienced suicidal episodes, while heart patients saw their blood pressure rise. These alarming reports were borne out by research conducted by New York-based independent health group ConsumerLab.com.

According to ConsumerLab’s founder and president Tod Cooperman, “The idea that they’re the same is a myth.”

Cooperman is a physician, scientist and economist with more than 16 years’ experience studying health issues affecting Americans. “Generics can differ and do differ significantly from the branded medications,” he says.

To encourage companies producing biologics to achieve biointerchangeability, the Obama administration has granted 12 months of exclusivity for the first bioequivalent products to be marketed in each drug class, a decision potentially worth hundreds of millions of dollars to companies that are first over the line.

The flagship drug for Biogenerics is Neukine, a version of granulocyte-colony stimulating factor (G-CSF), a drug used to boost the white blood cell count of cancer patients undergoing chemotherapy.

Virtually all patients who receive chemo also receive G-CSF, which in Australia costs about $2000 for a course of 10 pills. The global market for G-CSF is estimated at more than $6 billion.

To guarantee that Neukine is totally interchangeable with Amgen’s original product, Neupogen, Biogenerics is conducting rigorous US-style trials.

Simpson predicts the company will be first to market.

If Neukine passes the test and goes on sale, Simpson claims it will be about 95 per cent cheaper than Neupogen. Clearly, patients facing huge bills for the branded drug will welcome the alternative.

And Simpson? While he continues to argue the TGA should follow the US lead, he knows he made the right decision back in 2005.