There should be no data exclusivity period not because of the limits on competition. There should be no data exclusivity period because NO BIOSIMILAR SHOULD EVER BE ALLOWED TO PIGGY BACK!

SA, you fail to understand that the data exclusivity is in place because the generics do not want to pay to prove their biologic treatments are safe. They want to use reams of clinical trial data generated during the original FDA approvals for free. They feel their “BIOSIMILAR” is good enough that they don’t need to prove safety.

There are several problem with this model:
1) The “biosimilar” may not be similar enough to have the same safety profile. Celluar processing, unlike chemical manufacturing, does not always produce exactly the same product. There may be differences in the protein produced (transcription, translation, folding, etc), differences in the post-translational processing (cleavage, glycosylation, co-factors, etc), and differences in the contaminants. All of this may affect the efficacy and side-effects of the biosimilar, the biosimilar is not equivalent to the original and may cause deleterious effects. There may be problems with immunogenicity that weren’t present with the original drug. They may not be able to produce the same quality biosimilar over longer periods of time. Their production strain may not be as stable. All of these problems and more would be ferretted out during clinical trials that should be required for each biosimilar.
2) The branded company generated that data for FDA approval. If you give away that information to the biosimilar – clinical data, materials and methods, communications with the FDA, and other information that may or may not be available to the public, you may limit the level of disclosure for the original branded drug. They may not disclose critical information required to identify problems like long-term immunogenicity, drug interactions, childhood data, and the like, if they do not want to teach competitors tricks of the trade.
3) The biosimilar may not have all of the data required to deliver a dependable product. The branded company may have spent years/$$$ to identify the right number of “Units” to deliver biological consistency. Because each protein has a different level of activity, the biologic may not have all the information required to deliver the same level of activity. Delivering more or less of the biologic may not have the same efficacy.

In summary, to ensure quality biologics are delivered each company should be required to conduct its own expensive clinical trials. They may use the standard information available publicly through the FDA to design a clinical trial (this will save them time and money). BUT they must be required to prove they can deliver a quality biological product for the duration of the clinical trial period. They should be required to show the same efficacy, safety, toxicity, and side effects as required for any drug. Each biologic should be considered individually, not based off products produced by a different system. Notably, this allows them to start the clinical trial during orange book protection because all of the data would be required for FDA approval. They could be ready as soon as patent protection (with extensions) expired.

Best regards,

Mike

This post was mentioned on Twitter by ipwatchdog: Fact vs. Fiction: The Truth on Biologics and Biosimilars – Facts on data exclusivity for biologics and why they matter. http://bit.ly/5dCDXb...

Thanks so much for clearing that up. Do you know which Senator threw the first dart? Do you know what happened to the dart board? If it is for sale, perhaps listed on eBay, I would love to buy it and hang it in my office!

Additionally, you say: “The current exclusivity period for chemical drugs is 5 years.”

Sadly, you are wrong. I suspect you get the 5 years date because patent rights can be extended an extra 5 years to help account for delay caused by the FDA. That does NOT mean drugs are given only 5 years, it means they are given 5 EXTRA years. If you knew anything about this area you would understand that brand name pharmaceutical drugs typically enjoy in the range of about 10 to 14 years worth of exclusivity.

You also say: “No other industry on the planet is afforded a period of monopoly.”

This is just silly. You obviously are not concerned with facts. It is 100% wrong to say that no industry enjoys exclusive rights. That is exactly what patents provide. By the way, patents and data exclusivity do not create a monopoly. You should really read the article to learn why.

In any event, I look forward to your response on the dart board. I would LOVE to acquire it if at all possible.

-Gene