There is a policy interest in driving the biosimilar market. Among other reasons, increasing the number of generic drugs and biosimilars on the market addresses another policy priority – having an impact on the high cost of medicine. The approval of generic drugs has been at record highs the past few years, and FDA is also doing all that it can to facilitate the market for biosimilars. This is one of the few things FDA can actually do to address the issue of price, even if in the totality of things it is only nibbling away at the edge of a much larger issue.
So far in 2020, FDA has taken a series of actions designed to enhance the market for biosimilars.
- On February 3, FDA posted a draft guidance document for public comment entitled “Biosimilars and Interchangeable Biosimilars; Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed” outlining the procedure for such an application as well as adding a condition of use. Comments are open through April 6, 2020.
- On February 6, FDA issued a draft guidance on Biosimilar Licensing and Labeling, Timing of Certain Supplement Reviews which describes how companies can prepare draft labeling for biosimilar products and sets the timeline for consideration to a 6-month review cycle.
- Most significantly for communicators who work in the promotion of medicines, on February 3 FDA released a draft guidance “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers” outlining guideposts for communication, particularly around making comparisons between biosimilars and reference products. The draft provides a range of Q&A that presents multiple examples of promotional language that is both appropriate and considered inappropriate by the agency. To underscore the importance of the action, FDA announced the draft guidance in a release that also announced a joint effort with the Federal Trade Commission (FTC) and the holding of a public workshop to be held March 9 at the FDA campus.
The approval and marketing structures have been primed by FDA to facilitate approvals and uptake of biosimilars. But there are certainly other impediments. For example, currently due to patent issues, several of the biosimilars that have been approved are not brought to market. A study published last year in the AMA Journal of Ethics (AMA J Ethics. 2019;21(8):E668-678. doi: 10.1001/amajethics.2019.668) of the 17 biosimilars approved, only 7 had made it to market. It is an example of only one of many issues that have consequences for uptake.
The more on the market, the merrier (for price). For generic drugs, the rule of thumb has been that the more that are on the market to treat a particular condition, the lower the price for treatment. But for biosimilars, we are not yet a point where there are enough on the market to have a significant impact on pricing. When it comes to biosimilar entries impacting price, we are looking at a process, not an event. FDA has worked to facilitate the process. The effects, however, would appear to be something for which we should be prepared to wait.
In the meantime, there are more near-term consequences for biosimilar marketing. The joint announcement by FDA and FTC not only sets up the guardrails for communications in the industry, it also is a signal of intent. The agencies will be watching closely and likely looking for a circumstance by which enforcement can stress the existence of the guardrails even more keenly. Despite the fact that enforcement by FDA with regard to promotional communications has been at historic lows, they agency seems to be saying pay attention. So pay attention.