According to the Pharmaceutical Care Management Association (PCMA), biosimilars can play a much more influential role in managing the cost of specialty pharmaceuticals; however, the federal government will have to take stronger initiatives to make that happen.
The trade organization’s white paper “PBMs Support the Proliferation and Use of Biosimilars” outlines some key steps that could change the landscape of biosimilar development and introductions in the United States. The PCMA issued its recommendations on the eve of the first adalimumab biosimilar launch, the first of the major biosimilars to be managed by pharmacy benefit managers (PBMs).
First, PCMA urges that current market exclusivity be reduced from the current 12 years to seven years, which “would provide sufficient financial return for manufacturers while speeding biosimilars to market.” This was a stipulation the Obama Administration had fought for in the original biosimilar pathway legislation.
Second, the organization seeks prohibitions on patent thickets and product hopping. Calling both practices “anticompetitive,” the former results from the filing of redundant and overlapping patents that serve no purpose but to delay competition. In the case of product hopping, the reference manufacturer makes a relatively minor change to a product in an effort to create a new pharmaceutical that has its own exclusivity cycle, and seeks to shift patient utilization from the older product to the newer one, to avoid biosimilar competition.
Third, PCMA recommends outlawing “pay-for-delay” agreements, which “allow brand drug and biologic patent holders to pay potential competitors to delay market entry” of biosimilars or generics. Technically, if the first two recommendations were enacted, there would be little incentive for a biosimilar manufacturer to participate in a pay-for-delay agreement, which would also halt any patent litigation.
Finally, the organization suggests removing the interchangeability designation. This makes some sense, as the term is ultimately confusing and potentially hinders utilization of “noninterchangeable” biosimilars, without a basis in science.
None of these recommendations would be simple to implement, requiring statutory and/or regulatory action, which could take years to cultivate. However, most of these points are echoes of previous calls in the past.
The effects of these actions would be undeniable and disrupt the pharmaceutical industry’s profits and pipeline. Perhaps that is why the pharmaceutical manufacturers trade association, PhRMA, was quick to counter in an Email to Politico, “These [PBM] proposals are anti-innovation and will limit patient access to the next generation of cures. When they support reforming the rebate system, we will take their alleged concerns more seriously.” Yes, well, touché.