Biosimilars are coming!
What pharmacists need to know about biosimilars
- The first biosimilar bioequivalent and biologic add-on drugs have been approved, and many more are expected to come to market in the future.
- Pharmacists will play a key role in decisions about dispensing biosimilars.
- It is important for pharmacists to understand specifics about biosimilars that have been approved, the role pharmacists can play in dispensing them, and the opportunity in biosimilars.
Due to science, legislation and economics, multiple biosimilar products are expected to come to market in the future.1
Conventional medications are generally made from chemicals, making their structure easy to define and copy by following a “recipe.”
In contrast, biological medications (“biologics”) are generally derived from a living organism, including humans, animals, microorganisms or yeast. Biologics can’t be made following a recipe.
A biosimilar is a product that is not identical to but is highly similar to an existing biological “reference” product. Biosimilars resemble reference products and elicit the same clinical response.2
The Biologics Price Competition and Innovation Act of 2009 created a new abbreviated approval process for follow-on biologics. This abbreviated pathway substantially shortened the approval times and reduced the size and length of required clinical trials.3
Biosimilars are forecasted to save billions of dollars in U.S. healthcare costs,4 just as generics have produced considerable savings compared to more costly branded drugs.
In March 2015, the first biosimilar (Zarxio; filgrastim-sndz) was approved by the FDA,5 with the second biosimilar (Inflectra; infliximab-dyyb) approved in April 2016.6
With the initial biosimilars now approved, additional applications are already under review and a large number of anticipated approvals are in the works.7
What pharmacists need to pay attention to
The biosimilar wave is just beginning and is poised for significant growth and impact in healthcare. Important topics for pharmacists to be aware of include:
- What’s been approved. Thus far the three biosimilars that have been approved by the FDA are:
- Zarxio (by Sandoz) is biosimilar to Neupogen (by Amgen)
- Inflectra (by Celltrion) is biosimilar to Remicade (by Janssen Biotech)
- Lantus-Sandoz, Basalgar-Lilly, biologic equivalent, it cannot be automatically interchanged
Many more biosimilars are expected to be approved in coming years. It is important for pharmacists to know what has been approved, what it is biosimilar to, and the approved indications.
- Pharmacists’ dispensing options. Already, nearly 20 states have passed laws that allow pharmacists to substitute an interchangeable biosimilar (which is a certain type of biosimilar) for a brand-name biologic, without the prescribing physician intervening.8
These laws exist — even though no interchangeable biosimilars have been approved — to give pharmacists the flexibility to provide lower-cost, equally efficacious drugs, if such drugs exist. This gives pharmacists a very important role in future dispensing decisions as more biosimilars are approved.
- Biosimilar naming conventions. There is not yet a naming convention for biosimilars. Research has shown that pharmacists prefer a naming convention for biosimilars that includes a nonproprietary proper name with a designated suffix. Levels of confidence among pharmacists in substituting a biosimilar for a reference biologic are highest when products share the same nonproprietary name.9
Pharmacists are encouraged to follow the biosimilar naming debate and stay tuned to the FDA’s decision on names.
- Biosimilar reporting requirements. Some states are considering laws requiring pharmacists to provide pre- or post-dispensing notification to prescribers when a biosimilar is dispensed. About 65% of pharmacists indicated such reporting requirements would impose a burden, but only 28% stated it would make them less likely to dispense a biosimilar.10
Pharmacists need to pay close attention to state-level laws and reporting requirements.
- The opportunity in biosimilars. Biosimilars may follow a similar path as generics. Today, nearly 8 in 10 prescriptions are for generic drugs, which on average cost 80% to 85% less than branded drugs.11 Advantages of generics include lower cost, greater access to medications, and possibly improved adherence. For pharmacies, the profit margins on generics are higher than for branded drugs, though the total amount of profit per prescription is lower.12 Over time, a similar pattern may emerge for biosimilars.
As the president of the Biosimilars Forum recently said, “We know that some of the most difficult diseases that afflict people in the United States are best treated with biological medicines. The introduction of biosimilars is anticipated to help drive lower cost burdens for the U.S. healthcare system. It will also help expand earlier, more consistent access to these important medicines.”13 This represents an opportunity for patients, for the healthcare system and for pharmacies.
So, biosimilars are coming, their impact could be substantial, pharmacists will play a key role, and the opportunity is significant. Pharmacists should closely monitor new approvals, naming conventions, legislation and opportunities to use biosimilars to benefit patients.