When policy changes, communications must support the change by informing the stakeholders how it impacts them and the decisions they will have to make. When it comes to biosimilars, now is such a time. The question is – who does it?
From a regulatory and communications perspective, the new year started out with a milestone. During the first week of January, FDA’s Oncologic Drugs Advisory Committee voted unanimously to recommend approval of a biosimilar product to the reference biologic Neupogen. This was one more leg in the construction of a regulatory pathway for the formalized and regular approval of biosimilars. Another Advisory Committee meeting, this time for the Arthritis Advisory Committee was set up for March 17 – now postponed – to consider a second biosimilar.
In other words, the construction of the pathway begun during the first decade of the century is about to be trod upon in the second. With at least one recommendation for approval by an advisory committee it is only a matter of time before FDA acts to approve such a product.
FDA has provided several guidance documents with respect to biosimilars, but there are still many questions outstanding.
The development of the generic drug market place has had a tremendous impact on drug prices and health care spending. The legislation that created the pathway for generic drugs streamlined the process for getting a drug approved and consequently unleashed a flood of generics leading many to establish strong incentives for prescribers and patients to embrace their use.
It is the generic drug experience that provides the framework for public understanding how biosimilars will work, but there are important questions that arise in the case of biosimilars that do not exist with drugs. Drugs are chemical recipes – biologics involve living cells. For that reason among others, many will argue, the experience with generic drugs is not replicable with respect to biosimilars. There are many important differences. And how these differences are treated and how the policy decisions are resolved will be the substantive basis for important educational efforts aimed at both prescribers and patients.
As the regulatory pathway takes greater shape and increasing numbers of approved biosimilars make their way through it, there will be an increasing need for education of the stakeholders on key questions:
- What will the circumstances of patient choice be and on what can they rely in making their decisions?
- How will biosimilars be named – an issue which impacts a number of subsequent sub-issues?
While there has been a great deal of focus on dealing with the scientific parts of the pathway, answers to these questions have a large impact on uptake and utilization. Key to support along those lines is going to be extremely effective communication to explain to patients when, and if, they will have circumstances where there is choice and then what factors should go into their choice, assuming they get to make one. What are the factors that go into making a decision – and where will one find the information to make a decision that is informed by the experiences of others and the facts? And moreover, what is the name of a product and how does one link it to the reference product?
Finally, who is in the best position to deliver the answers to these questions. Inevitably it will be a number of outlets, but two stand out – professional medical societies and patient groups. And in particular, the medical societies and patient groups of the therapeutic categories earliest affected by the emergence of biosimilars into the treatment environment relate to the jurisdiction of the two advisory committees considering the approval of new biosimilars – oncology and arthritis. How the respective groups for each of these disease areas communicate around these issues will provide their own education pathway for others.
So as the regulatory pathway gets some of its final construction underway, it is well past the time to begin constructing the non-regulatory pathway of patient and provider education and consider the ways and means by which communication has to get out in front of important policy changes.