Fierce Biotech reports this morning that Amgen and Genentech (parent Roche) are starting to expend noticeable energy on influencing biosimilar legislation at the State level. In particular, both companies are trying to make it difficult to for a biosimilar achieve regulatory interchangeability with the reference product. This would prevent pharmacists from just switching to a new biosimilar without consulting with a prescribing physician. At the Federal level, both companies are also lobbying to prevent a biosimilar from having the same generic name as the branded product. In both cases, these efforts raise more hurdles to easy substitution.
Of course, if you were a shareholder of either company, and of Big Pharma companies in general, you'd be infavor of them competing however they needed to in order to maintain profitability as long as possible by preventing easy biosimilar competition. Patients, thrid-party payers and the government may have different ideas when it comes to saving money on drug costs. In the small molecule world, generics have already shown their ability to liquidate the sales and profits of blockbuster drugs coming off patent in a mere matter of months. The Big Biotech's would like to slow this down considerably in the case of biosimilars.
Right now, they are doing this by raising possible safety questions and challenging interchangeabililty attempts before the biosimilar competition gets entrenched. Of course, some of these companies are playing both sides of the fence -- they don't want to copy their own drugs but do copy the drugs of others. We'll have to see how this plays out.
Posted by Bruce Lehr Jan 25th 2013.