Follow-on biologics(FOB's) or biosimilars fall into a different category of generic drug than we’re used to. For instance, we're used to hearing of generics for the oral meds many of us take. These ‘traditional’ generics are chemically-synthesized copies of brand name drugs. Klonopin, for instance, is the brand name for the drug, clonazepam. Since 1997, several manufacturers have produced generic clonazepam. We take it for granted that these generics do the same thing as the original or innovator drug and, generally, they do. Generics come on the scene mainly because the patent rights have run out for the company that produced the first pill. With generics, manufacturers must verify that the active ingredient is the same as in the brand name drug and that it has comparable pharmacological properties once taken by the patient. No clinical trials generally are required for these drugs except in some instances as required by the FDA. So much for the oral chemical types of drugs. Enter the biologics.
Biologics have active substances that are typically much larger and more complex than the chemical drugs. They are usually proteins derived from living organisms with a consequent potential for variability and immunogenicity (i.e., may stimulate immune reactions.) How does that affect all of us? At this time, Congress is flexing its muscles and wants to introduce, and hopefully, pass a bill that would NOT require rigorous clinical studies before approving generics for these biologics products. Many companies are coming to the end of their patent periods and this is the reason for this new legislation in Congress. Henry Waxman, congressman from California, has proposed this new bill. The lack of clinical testing is but just one of the liberal ideas behind this new bill. Biologics are not just used in the field of dystonia but in many other fields of medicine as well. Right now, however, we're interested in those biologics in our own field and how they will affect us. The innovator in this field was BOTOX (botulinum toxin type A) as produced by Allergan. Its orphan drug protection granted by the FDA will run out shortly. Of course, there is also Myobloc as made by Solstice Neurosciences but, in the very near future, there could be Dysport as made by Ipsen, out of England, and then, still undergoing clinical testing, is NT201, a product of Merz Pharmaceuticals from Germany. There could be additional forms of follow-on botulinum toxin products after these two. It should be noted that like BOTOX, Dysport and NT201 are serotype A toxins while Myobloc is a setotype B toxin.
You might say this is good. The more the merrier and the lower the cost may go and well it might and that would be a positive but, as in our earlier letter to all of you several months ago, there could be some BIG drawbacks to this line of thinking.
Number one would be the lack of clinical testing of any new products. Remember, we're working with the world's most deadly poison in botulinum toxins and it sure should go through some kind of clinical testing. Then, another big problem could be the INTERCHANGEABILITY factor in all this. An analogy would be Premarin, an estrogen replacement drug. It’s made from the urine of pregnant mares (female horses). So far, even though the patent rights expired, there aren’t any new drug companies in this field. One step further, just reading this, would you feel comfortable with a competitor coming along and not having to do any clinical testing???????
Yes, lower prices appeal to all of us but SAFETY is also very, very important. As time goes along and, if this bill picks up more power we will keep you advised. Right now it is being backed by Henry Waxman in the House and by Hillary Clinton and Charles Shumer in the Senate. It’s also being supported by AARP and other similar associations. I might say that one of the big reasons this is being pushed is that CMS, which is the bureau that controls Medicare and Medicaid, wants to cut costs and this is one way they could do so in a hurry. BUT consider if you went in for your injections and you've been on BOTOX or Myobloc for many years and doing well, Medicare may tell you that now you should take Dysport or NT201 because they're cheaper and then the next time it could be altogether different. PLUS, how do you know, or even the doctor know, as to the INTERCHANGEABILITY????? How much of BOTOX = how much of Dysport for instance??? And, ONE IMPORTANT POINT, when Medicare does something all private insurance companies follow suit. Do you want this? Write your legislator and advise him/her of your thoughts.
Our symposium just added another presenter and it will be to explain just this situation. He is a microbiologist from Allergan and he is Ryan Irvine, PhD. Just another very good reason you should come. See you soon!!!
And please remember…each and every day…THINK POSITIVE…smile…and laugh… a lot.
