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 One reassurance is that no approved or marketed biosimilars in Europe have been withdrawn due to safety concerns.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.



2. Biologic and specialty pharmaceuticals comprise the fastest-growing pharmaceutical expense in the United States.

Dr. Stevenson noted that biologics could make up 32% of total big pharma sales by 2023, according to The Economist. In 2014, 7 of the top 10 drugs by sales were biologics, as well.

Dr. Stevenson showed a list of the top 15 drugs by expenditures in clinics in 2014 and circled one of them (pemetrexed) because it was the only one that was not a biologic.

As more biosimilars enter the market, they will have a significant impact on pharmaceutical expense trends, and the session speakers noted that there will be significant pressure from payers to use biosimilars to control health care costs.

3. The naming of biosimilars is still somewhat in the air.

There are 2 main camps on how biosimilars should be named: those who think biosimilars should have the exact same international nonproprietary name (INN) as the reference product, and those who believe they should have a distinct INN to differentiate them from the reference product and other biosimilars.

“I think it’s getting close to being resolved, but it’s my editorial opinion that it’s being resolved in a way that’s not going to be very good,” Dr. Stevenson said.

Some of the benefits in having the same name include the fact that it would encourage providers and patients to see the products as highly similar, which could help facilitate adoption and substitution. On the flip side, however, having the same name would make it harder to trace for pharmacovigilance.

Those who want a new distinct name point to the benefits of improved pharmacovigilance and the ability to identify 2 distinct products, though there may be confusion on whether the products are interchangeable. There may also be more hesitation with adoption and substitution.

In Europe, the identical INN and the brand name are used.

The World Health Organization proposes using the same INN and 4 randomly assigned letters as a suffix. The FDA also proposes an INN with a random 4-letter suffix, including the reference products.

However, there are concerns that such a complex name would increase the likelihood of errors and cause confusion among the current biologics that would need to have their names changed.

In Dr. Stevenson’s opinion, the random 4-letter suffix poses a problem because the letters would confer no meaning. If there are 3 filgrastims in a system with different suffixes, for example, no one is going to remember what those suffixes mean.

“I think that prescribers are just going to pick one,” Dr. Stevenson said, adding that this could defeat the purpose of the unique names for pharmacovigilance’s sake.

Regardless, he said it will be a challenge to figure out how to best enter these names into electronic systems (ordering systems, pharmacy systems, dispensing, e-prescribing, order sets, and pathways) so that providers aren’t mixing up the names of products unintentionally.

Drs. Li and Stevenson suggested that a few things pharmacists will need to do to prepare include considering the scope of indications for use, analyzing costs and reimbursements, preparing their IT systems to ensure pharmacovigilance, considering processes for transitions of care, and educating patients.
 
To read a out recent innovations and approaches to biosimilars, from the 2018 FIP World Congress, click here.