3 Facts About Biosimilars Pharmacists Should Know

MARCH 07, 2016
Meghan Ross, Senior Associate Editor
Although only 1 biosimilar has been approved in the United States thus far, pharmacists can expect to see a lot more action in this space in the next few years.

Edward C. Li, PharmD, MPH, BCOP, of the University of New England College of Pharmacy, and James G. Stevenson, PharmD, FASHP, of the University of Michigan College of Pharmacy, provided some background information on the pathway and characteristics of biosimilars and what’s to come for them in the future at the American Pharmacists Association (APhA) 2016 Annual Meeting & Exposition.

According to the FDA, biosimilars are highly similar to the reference biological product despite minor differences in inactive components, and they express no clinically meaningful differences in safety, purity, or potency of the reference product.

Two of the benefits of biosimilars are that they can produce cost savings and increase patients’ access to medications. One thing that pharmacists should note is biosimilars’ immunogenicity concerns related to diminished efficacy or safety or adverse reactions.

Here are 3 key takeaways from Drs. Li and Stevenson on what pharmacists should about biosimilars.

1. The FDA has been busy writing policy related to biosimilars.

“It’s a year later since we did this talk at APhA, and we still have 1 biosimilar available,” Dr. Li said. “…The question is: are there no applications? Or is the FDA not reviewing applications in time?”
Between 2014 and the first 2 quarters of 2015, only 5 applications for biosimilars were submitted to the FDA. Despite receiving few applications, the FDA has been busy with meeting requests and scheduled meetings.

There were 17 biosimilar initial advisory meeting requests between 2013 and 2015—3 for biological product development (BPD) type 1, 72 for BPD type 2, 16 for BPD type 3, and 5 for BPD type 4.

Between 28 and 51 FDA staff members were identified by regulatory project managers as being involved in each 351(k) biologic licensing application. Labor costs for these FDA staff members totaled more than $33 million from fiscal year 2013 to the first 2 quarters of 2015.

The session speakers at APhA mentioned that the FDA could be taking its time in reviewing and approving biosimilars so as not to “poison the well” and cause concerns about product safety. One reassurance is that no approved or marketed biosimilars in Europe have been withdrawn due to safety concerns.

Filgrastim-sndz (Zarxio) is technically the only biosimilar in the United States, but enoxaparin, tbo-filgrastim, and insulin glargine are all approved as biosimilars in Europe.

Currently, biosimilars are developed and tested for biosimilarity before receiving FDA approval. It isn’t until after the approval that the products undergo testing and confirmation of interchangeability, plus postmarket monitoring.

There is no FDA guidance on interchangeability yet, so pharmacists will need to keep an eye out for this forthcoming information on how substitutions will be made. However, this poses an operational challenge that states will need to address concerning the pharmacist’s role in substituting a biosimilar for a reference product.

Other challenges include medication reconciliation and potential differences in federal and state regulations. Currently, legislation on biologic and biosimilar substitution varies across the country.