What's New with Biosimilars?


Over the last few months, new developments have taken place within the biosimilar market including new drug approvals and guidance documents released by the FDA.

Biosimilar products entered the US drug marketplace in 2010 with the passing of the Biologics Price Competition and Innovation (BCPI) Act. Though biological products account for <1% of all prescriptions dispensed in the United States, their expenditures axmount to 28% of prescription drug cost.1 The passing of the BCPI Act created an abbreviated pathway toward FDA approval for biosimilar and interchangeable biological products with the intent to create market competition, decrease healthcare costs, and provide greater patient accessibility.

Over the last few months, new developments have taken place within the biosimilar market including drug approvals and new guidance documents released by the FDA.

New Drug Approvals

Biosimilar manufacturers have to show that there are no clinically-meaningful differences in safety, purity, and potency between the reference product and biosimilar and that there are only minor differences in clinically inactive components. Biosimilars must have the same mechanism of action, route of administration, dosage form, and strength as their reference product. They are only able to seek indications that the reference product has been approved for and the biosimilar product may or may not be approved for all of the indications as the reference product.

To date, 4 biosimilars have been approved in the United States. In March of 2015, Zarxio (filgrastim-sndz), a biosimilar for of Neupogen, was the first biosimilar approved. Zarxio was followed by Inflectra (infliximab-dyyb) in April 2016, Erelzi (etanercept-szzs) in August 2016, and Amjevita (adalimumab-atto) in September 2016.

Many patents for biological drugs are expiring in the next several years and there are currently more than 50 biosimilars in trials in the United States and Europe. A study estimated that biosimilars could save the United States $44 billion dollars on direct spending of biologics between 2014-2024.2


The FDA recently released a guidance document recommending biological products licensed under the BCPI Act bear a proper named consisting of a core name (ex. filgrastim, epoetin alfa) followed by a 4-letter FDA-designated suffix. The 4-letter suffix serves as an identifier and should:

  • Be unique and devoid of meaning
  • Be lowercase, of which at least 3 letters are distinct
  • Not resemble a medical acronym
  • Not look similar to a currently marketed product
  • Not be false or misleading in respect to safety and efficacy

The biosimilar applicant is welcome to submit up to 10 proposed suffixes in order of the applicant’s preference with a recommendation to include supporting analyses for the FDA’s consideration.

The FDA recommends that the suffixes be used in routine ordering to facilitate pharmacovigilance in originator biological products and biosimilar products and also promote accurate identification and prevent inadvertent substitution for biosimilars not deemed interchangeable.

The FDA intends to apply the naming system to both newly licensed and previously licensed biological products in order to 1). prevent patients from receiving a product different than what was prescribed, 2). promote manufacturer-specific pharmacovigilance, and 3). advance accurate perceptions of these biological products.3


For a biosimilar to be deemed interchangeable, it must produce the same clinical results as the reference product in any given patient. If the biosimilar is to be administered more than once, there should be no greater risk in terms of safety and diminished efficacy from switching to the interchangeable product from the reference product then from using the reference product alone.

In the FDA’s recently-released guidance for interchangeability, they recommend that sponsors conduct one or more switching studies comparing the safety and efficacy of the reference product and the biosimilar. Their recommendations also give more clarification on the data and information needed to support that an interchangeable biosimilar “can be expected to produce the same clinical result as the reference product in any given patient." This information includes giving pharmacokinetics and biodistribution in different patient populations, considering the differences in toxicities in each condition of use and patient population, and evaluating the immunogenicity risk in different populations.4

Having an interchangeable pathway is paramount to the adoption of biosimilars in the United States. With the pressure of high drug prices, this route opens up the door for decreased healthcare costs and better patient access.

Pharmacists play an important role in the adoption of biosimilars by educating healthcare providers and patients, working with insurance companies, and monitoring post marketing surveillance data for biosimilars.


1. Sarpatwari A, Avorn J, Kesselheim A. Progress and hurdles for follow-on biologics. NEJM. 2015; 372:2380-2382. http://www.nejm.org/doi/full/10.1056/NEJMp1504672?query=TOC. Accessed Feb. 12, 2017.

2. Mulcahy A, Predmore Z, Mattke S. The cost savings potential of biosimilar drugs in the United States. https://www.rand.org/content/dam/rand/pubs/perspectives/PE100/PE127/RAND_PE127.pdf. Accessed Feb 16, 2017.

3. US Food and Drug Administration. Nonproprietary naming of biological products. http://www.fda.gov/downloads/drugs/guidances/ucm459987.pdf. Accessed Feb. 10, 2017.

4. US Food and Drug Administration. Considerations in demonstrating interchangeability with a reference product: guidance for industry. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf. Accessed Feb. 16, 2017.

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