One Down, 13 To Go: A Biosimilar Bill Falls Flat

As more than a dozen state legislatures mull over bills that would make it more difficult to allow substitution of biosimilars, at least one effort appears to have gone nowhere. Despite identical bills that were introduced in the state Senate and House in Mississippi, the twin pieces of legislation failed to proceed to committee votes and, as a result, cannot be reintroduced in the current legislative session. This apparently marks the first such defeat for a closely watched effort by such big biotechs as Genentech and Amgen to thwart rivals from having easy entre to their lucrative markets. Over the past few weeks, you may recall, legislators in several states have been introducing bills that would allow interchangeable biosimilar substitution, but only if more cumbersome conditions are met by prescribing physicians and pharmacies (back story). A key condition noted in the bills is that a biosimilar must have been deemed by the FDA to be interchangeable with the prescribed medicine for the specified indicated use (read the two Mississippi bills here and here). The legislation was hatched even though the FDA has not yet approved a biosimilar yet or decided whether a biosimilar is interchangeable with a brand-name biologic. As we reported previously, there is debate about interchangeability. The Alliance for Safe Biologic Medicines, a group that includes Amgen (AMGN), Genentech and the BIO trade group, wants clear lines drawn for substitution, such as giving physicians authori...
Source: Pharmalot - Category: Pharma Commentators Authors: Tags: Uncategorized Amgen Avastin Biologics Biosimilars Eli Lilly FDA Genentech Herceptin Roche Source Type: blogs