tag:blogger.com,1999:blog-36634196.post2085356579234564847..comments2023-10-09T11:33:37.853-05:00Comments on The IN VIVO Blog: Follow-On Biologics: 1984 All Over Again?Chris Morrisonhttp://www.blogger.com/profile/04075266444951558159noreply@blogger.comBlogger1125tag:blogger.com,1999:blog-36634196.post-50737227761108692672009-04-24T09:07:00.000-05:002009-04-24T09:07:00.000-05:00Is anyone looking at the number of US biotech jobs...Is anyone looking at the number of US biotech jobs that might be lost as the result of biosimilars and factoring this into the cost savings equation? Does anyone know if more biotech jobs would be outsourced as the result of creating an FDA framework for the approval of biosimilars? I worry that hasty approval of a framework for the FDA approval of follow on biologics (or biosimilars) will hasten outsourcing of high paying biotech jobs.<br /><br />I am not an expert but it would seem to me that the issue of exclusivity may be off point. We've gotten reports from credible sources of outdated insulin dispenses and samples, including one that may have precipitated changes in glucose levels and additional medical expense. Even before biosimilar versions were approved, we were hearing about diversion of expired HgH. Unfortunately, lack of state oversight resources did not and does not allow these types of issues to be followed up on in my and likely many other states. I seem to recall that there was a false claim settlement several years ago related to the over-marketing of HgH. In addition, there are new reports about the over-marketing of ESA's. This seems to indicate that the real problem...the gap...that is creating access issues is not one of manufacturing capacity. If anything, these antidotal reports appear to indicate that there is excess manufacturing capacity and more than ample product supply in at least several components of the biotech sector. <br /><br />While there appears to be adequate manufacturing capacity in at least some parts of the biotech sector, the patients who need these medicines are not able to access them. Maybe the real problem - the gap that needs to be closed- is one of access due to hurdles such as inadequate insurance coverage and inability to pay for medically necessary medicines. This is likely because of high co-pays and/or high cost, not because of lack of product availability. <br /><br />These medicines do not go directly from the pharmaceutical company to the patient. There are middlemen in between. It seems like these middlemen may have some control over patient access and cost. Maybe it would make sense to look at all of these sectors as well.<br /><br />I also worry that if biosimilar legislation is approved at this time it will amplify and further overwhelm FDA oversight and enforcement capacity at a time when new FDA appointees and FDA line personnel badly need our support. It seems like it would make sense to first ensure that the FDA, state pharmacy boards, other oversight entities, doctors and pharmacists have the resources that they need to ensure that current and future supplies of biotech drugs are both efficacious at time of use and accessible in a high enough (but not too high) doses to all of the US patients who need these lifesaving drugs.Anne PMEnoreply@blogger.com