This comes to us from Fierce Biotech this morning. Apparently, leading biosimilars (to be) producers have chosen to suspend their initial programs for drugs like Rituxan as their economic analysis shows that it will be much more expensive than once suspected to introduce products on the US market. Thus, company partners like Lonza/Teva and Merck/Samsung/BiogenIdec have recently cancelled or slowed their programs down.
This appears to be due almost solely to economic uncertainty created by US FDA. If more extensive clinical trial data is required, costs will sky rocket as this is the most expensive phase of drug development.
If this is the case, that clearly is NOT what the lawmakers intended when it put biosimilar legislation into law. I think they clearly wantd to creat more price competition (and price benefits for government payers) into play. But so far, it appears that Big Pharma has been largely successful in geting the FDA to require fairly extensive phase III data. They are even getting States to pass anti-interchangeability laws well in advance of any FDA drug approvals. Plus, companies like AbbVie, have made it abundantly clear that they will aggressively defend their patent and legal position around these drugs.
With billions at stake this is to be expected.
Posted by Bruce Lehr Apr 1st 2013