California is the fourth state to pass regulations restricting how biosimilars may be subsituted for the innovator drug. Under the legislation, physicians can refuse their patients access to biosimilars and pharmacies must inform patients if a biosimilar has been substituted for the original branded drug.
The FDA expressed concern that this type of legislation was aimed at "undermining the trust" in biosimilar products. They said this was a worrisome trend and represented a disservice to patients who could benefit from the less costly alternative.
Further, the FDA contended that the legislation that enable biosimilars in the US had already set a high bar on quality for these type of products, and that the FDA would implementing procedures and standards that would ensure safety and efficacy of these product for patients. In other words, FDA feels state legislators/regulators should butt out and le the FDA do its job.
FDA finished by reminding the populace that FDA had expertise in this area and that the legislation expressly called for approval of biosimilars and interchangeable products. FDA says it has had 57 requests for initial meetings from biosimilar sponsors covering 13 different reference drugs -- with 47 meetings having been held. The wheels are rolling.
Amgen and Genentech are widely seen as sponsoring this type of legislation, in California and other state legislatures, in an effort to help protect their innovator drugs. So far, four states have passed some form of legislation inhibiting interchangeability and 10 have turned it down. No doubt we will see more of this type of legislative battle as the first biosimilars wend their way through FDA.
I remain convinced that on balance the government will want to see biosimilars on the market with interchangeability in order to reduce drug expenditures -- most of which goes through the government now. This is an economic issue as much as a healthcare one.
Posted by Bruce Lehr Aug 30th 2013