U.S. Regulatory Process
Craig Wheeler, CEO of Momenta Pharmaceuticals, discussed the regulatory needs of the U.S. with respect to the licensing of biosimilars. “We need creative legislation and constructive dialog with the government,” he argued. Such legislation should empower and fund the FDA to review biosimilar applications by forging a pathway that allows for the possibility of substitutability, he added.
The burden of proof should fall on the applicant to demonstrate equivalence, and there should be appropriate mechanisms to preserve innovation incentives, he said. There should be a fair mechanism for patent review that protects both the innovator and the follow-on biologic under consideration. There should also be an appropriate period of data exclusivity for the innovator.
Wheeler further elaborated that legislation needs to be forward-looking and pro-competitive to spur innovation, pro-quality to raise the standard for analytical technologies, and pro-industry, that is, framed in a manner to bolster the reputation of the biotech community in the public eye through promotion of quality-based, cost-effective medicines.
“Biosimilar regulation is not about inhibiting or preventing legitimate competition, but rather, preserving the incentives for innovation in the development of new therapies,” stated Stephen Juelsgaard, J.D., DVM and executive vp at Genentech. “The biotech sector supports a path for follow-on biologics based on the right balance between lower cost of therapies and the need to maintain adequate incentives.”
According to Dr. Juelsgaard, under the current Hatch-Waxman legislation that governs protection of small molecules in the U.S., the generic compound and the original molecule must have identical structures in order to fall under the same patent umbrella. The problem for biologics patent protection is that under present law, the two substances must be “comparable” or “similar” to qualify for protection. But the biosimilar compound may have a composition that is different from that of the innovator molecule, and therefore, may not be covered by the innovator’s composition patent.
Given the vast R&D costs for a new biological product, a significant data-exclusivity period must be part of the legislation in order to provide sufficient incentive to companies to pursue new biotherapeutics. The current Hatch-Waxman Act, designed for small molecule drugs, is simply not adequate, according to Dr. Juelsgaard.