stem-cell.GIFThe Alliance of Minority Medical Associations (AMMA) and the Benenson Strategy Group held a national media briefing on poll results examining health care access and affordability in the US today.

Dr. Randall Maxey, M.D., said that polling data show that most voters are unhappy with Washington and they are looking for change.  While Iraq and the economy are most important issues, health care is a major concern.  Of the findings, the group said that voters want more affordable prescriptions and believe that pharmaceutical companies often have too many advantages over the public.

One of the highest priorities for the public, not surprising, is to reduce the cost of prescription drugs.  The findings were the same across all demographics.  The second highest priority is increased access to health facilities.

The AMMA believes that one way to make prescription drugs more affordable is make follow-on biologics available.  A person living with MS, for example, might spend from $16,500 to $29,000 each year on their biologic MS therapy.  Meanwhile, MS drugs Betaseron® (interferon beta-1b) and Avonex® (betaferon-1a) are off patent but increasing in price without competition.

The AMMA believes that follow-on biologics would provide needed competition and decrease the cost of these drugs.  They acknowledge that concern for patent and intellectual property rights are important but that it is also important for patients to be able to afford their prescriptions and 80% of those polled support making follow-on biologics available.

Interestingly, the findings show that (1) consumers have confidence in existing generics and (2) consumers have confidence in the FDA to properly oversee and regulate the approval of such follow-on biogenerics.  The study showed that 79% consider current generics safe and 85% would support biogenerics if the FDA can appropriately test the safety of the drugs.

The key issue, of course, is that any follow-on biologics have to be certified as to their biological effects and clinical efficacy through proper clinical and biologic testing.  While proper testing is certainly possible, the question is how much testing will be required in order for the FDA to adequately determine that a generic version of a biologic is the same as the original product.

With a small molecule/chemical drug, this determination is very easy because it is a matter of routine chemical analysis. A chemical structure either is or is not the same.  Biologic products are quite different in that they are far more complex. A biologic is manufactured in a living system such as a microorganism, or plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules often produced using recombinant DNA technology.

It is difficult, and sometimes impossible, to characterize a complex biologic by testing methods available in the laboratory, and some of the components of a finished biologic may be unknown.  Therefore, for biologics, the product may be inseparable from the process of making the product. Because the finished product cannot be fully characterized in the laboratory, manufacturers must ensure product consistency, quality, and purity by ensuring that the manufacturing process remains substantially the same over time.

Unfortunately, when the follow-on manufacturer establishes a new manufacturing process, beginning with new starting materials, it will produce a product that is different from and not therapeutically equivalent with that of the innovator. Because of the complexity of biologics, the only way to establish whether there are differences that affect the safety and effectiveness of the follow-on product is to conduct clinical trials.

To be approved as a generic, a drug must have the same active ingredient, strength, dosage form, and route of administration as the reference drug, and it must also be bioequivalent. This means that generic drugs are the same chemically as their innovator counterparts and that they act the same way in the body. The bioequivalence of the generic drug is demonstrated through relatively simple analysis such as blood level testing, without the need for human clinical trials. In approving a generic drug under 505(j) of the FDCA, FDA determines that the generic is “therapeutically equivalent” to the innovator drug, and is interchangeable with it.

The FDA has stated that it has not determined how interchangeability can be established for complex proteins (Biosimilars, September 2006).

See more from the AMMA here.
See the Biotechnology Industry Organization (BIO) fact sheets here.
More here: Draft Bill Lays Down Path to Follow-On Biologics.

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