Upcoming biosimilar logjam could provide cost savings for arthritis drugs
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The upcoming influx of new biosimilar drugs to the market could mitigate the cost of biologics to treat inflammatory diseases, said Steven Newmark, director of policy and chief legal officer for the Global Healthy Living Foundation.
Legal and patent disputes have caused many biosimilars to be restricted from coming into the market, but these issues are expected to be resolved over the next year. With biosimilars projected to enter the market in 2023, there may be an unprecedented number of options for inflammatory disease patients, and potentially much better access to drugs that can treat their conditions.
During an interview with Healio, Newmark discussed the reasons behind the upcoming biosimilar logjam, its potential effects on the drug market, and how health care providers will approach the new development.
Healio: Give me an overview – what is the biosimilar logjam?
Newmark: Although the FDA has approved 16 biosimilars in the immunology space, only a handful have entered the market, and we have seen a slow market uptick. There have been delays in commercial availability of biosimilars in part because of drawn-out patent disputes, settlements and other legal issues. This, in turn, delays patient access to affordable treatment options.
Healio: Why is this happening in 2023?
Newmark: As legal disputes are resolved, starting in 2023 we expect to see a bunch of new biosimilars enter the market, which will spur more competition, and bring down the price of biosimilars and their reference biologic. For example, there are seven biosimilars for the biologic drug known as Humira (adalimumab, Abbvie); all are already approved by the FDA but have been held up from coming into the market because of patent litigation.
One of the Humira biosimilars, Cyltezo (adalimumab-adbm, Boehringer Ingelheim), was recently approved as an interchangeable. This means that when it enters the market, pharmacists may substitute it for Humira without getting authorization from the prescriber, prior to substitution. While substitutions like this happens for small molecule drugs, this is new for biologics and will hopefully increase uptake in the market, generally. At Global Healthy Living Foundation, we’re monitoring this situation carefully. Cost savings that stem from new medications and competition aren’t apparent to patients unless their co-pays and deductibles are reduced. In addition, while we support and welcome biosimilars to increase treatment options, we don’t support substitutions without the provider and patient having an opportunity to discuss a proposed switch and then accept or decline it.
Healio: What will this development mean for treatment of rheumatoid arthritis and other such diseases? What effects will this have on patient access to the medicines they need?
Newmark: In the past, we’ve seen that when biosimilars are introduced, the utilization went up while costs went down. This means that patients who were not getting a biologic because of cost reasons now have better access. Hopefully, this means patients will get on medications sooner and stay on them, which is important for good outcomes in the long term. Treating arthritis and inflammatory diseases early can help relieve or reduce symptoms and prevent damage or long-term complications.
Also, in the autoimmune space, we currently only have infused biosimilars. In 2023, we will have self-administered biosimilars introduced in the U.S. This matters for patient access and preferences, and when patients feel confident in the decisions about their care it improves health outcomes.
Healio: How willing/comfortable do you expect most doctors to be to switch from the reference drug to the biosimilar?
Newmark: Data suggests that clinicians are hesitant to prescribe biosimilars and this creates a problem because biosimilars can enter the market and lower costs, but only if they are being prescribed. Physicians might be hesitant because they may not understand the rigor of the biosimilar approval process, because they might consider that the economics of biosimilars are not favorable enough, or because they have set prescribing patterns and are resistant to change. On the other hand, we want them to protect patients from unexpected switches they didn’t request.
Continued provider and patient education is the answer. We recently launched a podcast called Breaking Down Biosimilars to help get patients and providers more comfortable with biosimilars, and to enhance shared decision making.
Healio: What kind of field testing will these drugs get before entering the market?
Newmark: The FDA has strict guidelines to ensure safety, efficacy and quality of all medications for patients, including biosimilars. The FDA adopted the naming convention (4-letter suffix) for biosimilars to help with the pharmacovigilance and safe use for all biological products. Patients can be assured that the FDA has carefully evaluated these medications and will continue to monitor their use and safety in the real world, similar to the originator biologics.
Unlike small molecules, the FDA requires clinical trials to evaluate safety and efficacy of biosimilars in addition to laboratory pharmacokinetic testing. For small molecule generic approval FDA only requires laboratory pharmacokinetic testing.
Healio: How much will individual doctor decisions impact the market as this logjam plays out?
Newmark: Individual doctor decisions and prescribing patterns matter, as do patients’ preferences for biosimilars, but biosimilars being on a health plan’s formulary at a favorable price is as important for decision making.
The influence that pharmacy benefit managers (PBMs), health plans and manufacturers have on uptake of biosimilars simply through their negotiations and rebate walls cannot be understated and will impact the speed at which biosimilars start to cut into the current market leaders. Right now, PBMs place drugs on the formulary based in large part on the size of the rebate they receive. Biosimilars enter the market at an immediate disadvantage because if their list price is lower than the reference biologic, than there is no way for them to compete with the percent-based rebates offered by the reference products. This rebate wall will prevent many new biosimilars from entering the market as early as they possibly and safely can because as long as they need to go through PBMs to get onto a formulary, they will need to figure out a new way to compete with reference products other than rebate size.
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