The FDA is currently soliciting feedback to its recently published biosimilar guidelines. Understandably, many among innovator pharma have comments to provide. In its recent comments, Amgen asks the FDA if manufacturers are going to have to "maintain biosimilarity after approval." If so, Amgen warns this requirement over time would stifle upgrades in manufacturing and quality improvements -- which would be bad for patients and a burden to the industry. This could apply equally to innovators and biogenerics producers post-approval.
Amgen suggests that a biosimilar applicant make its comparisons to the innovator product during a limited period of time and then establish a reference standard. Amgen then wants the FDA to treat the innovator product and the biosimilar as separate drugs from that point forward. Then each can make changes to their manufacturing or quality based on the merits of their own data.
Industry commentators note however this would have implications on interchangeability -- likely the above approach would prevent these products from ever being considered interchangeable. Of course, Big Pharma and BIO have their reasons for not wanting to see interchangeability adopted anytime soon.
Posted by Bruce Lehr Apr 25th 2012.