Group agrees to substitution principles

An informal group of manufacturers of innovator biologics and biosimilars agreed to a set of principles that they proposed state legislators use going forward when creating substitution laws for interchangeable and innovator biologics. At a U.S. Federal Trade Commission workshop on Tuesday to discuss state regulations and biosimilar naming conventions, the group -- which includes Amgen Inc. (NASDAQ:AMGN), the Sandoz generics unit of Novartis AG (NYSE:NVS; SIX:NOVN), Hospira Inc. (NYSE:HSP) and Actavis plc (NYSE:ACT) -- said state laws should not treat interchangeable and innovator biologics differently. According to a copy of the principles obtained by BioCentury, state pharmacy laws should be updated to allow pharmacy substitution of biologics that FDA has approved as interchangeable. The principles also endorse a communication requirement, with entry into a patient's electronic health record of the product dispensed sufficient for communication to the prescriber of whether an innovator or interchangeable biologic was dispensed.

The principles have not uniformly been endorsed by the biosimilars industry. Bruce Leicher, SVP and general counsel at Momenta Pharmaceuticals Inc. (NASDAQ:MNTA), attacked the principles at the FTC meeting. He said they are anti-competitive and said they favor companies that intend to use sales forces to market interchangeable biologics over those that intend to rely on automatic substitution. The Generic Pharmaceutical Association (GPhA) is also opposed to the principles. ...