Process complexity could be barrier to biosimilars

The healthcare reform bill gives the FDA the power to approve follow-on biologics through an abbreviated process similar to the one for small molecule drugs. However, the complexity of biologics poses a difficult challenge for those trying to make a biosimilar product.

That generics makers know little about the manufacturing of branded biologics leads Motley Fool's Brian Orelli to speculate that the FDA will be even more rigorous in approving follow-on biologics than it is in approving the process and equipment changes made by manufacturers of approved products.

"Difficult requirements for approval of follow-on biologics will certainly keep the competition to a minimum and help the originators retain a fair amount of their original market share," Orelli advises investors.

And he says that some complex small molecule drugs pose the same problem for generics makers, even with the ANDA process. Applications for copies of Sanofi-Aventis's Lovenox by Teva and others linger at the FDA as the regulator decides whether the generic candidate is "identical enough" to the original. Likewise, GSK's asthma drug Advair, slated for patent expiration next year, is proving problematic. Delivery via inhaler slows approval, Orelli says.

- here's the column