Big Developments in Biosimilars


Biosimilars have been in the news quite a bit lately. Here’s an update on some of the big developments related to biosimilar development, approval, and regulations

About this time last year, I described the discussion occurring in state legislatures around biosimilars and the substitution of interchangeable biologics. Biosimilars have been in the news quite a bit since then. Here’s an update on some of the big developments related to biosimilar development, approval, and regulations.

1. Four biosimilars have been approved by the FDA.

The FDA’s list of approved biologic products, last updated in October of 2016, indicates there have been 4 biosimilar products approved. Although the approval of Zarxio back in March 2015—the first biosimilar product to be approved in the United States—may seem like old news, it remained the only biosimilar product on the market for more than a year. The next approval wasn’t until April 2016, when Inflectra finally received the FDA’s go-ahead. Since then, Erelzi and Amjevita were approved in August and September, respectively. Given that biosimilars are being hailed as a vital component in blunting the projected escalation in medication spending over the next several years, it’s nice to see more of these products making it to market. It’s worth noting, however, that we’re still a long way from the 21 biosimilar products that have been approved in Europe.

2. Suffixes on nonproprietary names for the recently approved products have no meaning.

Consistent with the guidance released for comment by the FDA in August 2015, the new products approved since Zarxio have suffixes that lack any purpose other than establishing each of the products as a unique entity. Nonproprietary names for Inflectra, Erelzi, and Amjevita are infliximab-dyyb, etanercept-szzs, and adalimumab-atto, respectively. As the guidance issued by the administration had indicated, these suffixes are unique and devoid of meaning. The FDA is also taking steps to ensure that any proposed suffix for biosimilar products should not1:

  • Be promotional, such as by making misrepresentations with respect to safety or efficacy.
  • Include abbreviations commonly used in clinical practice in a manner that may lead the suffix to be misinterpreted as another element on the prescription or order.
  • Contain or suggest any drug substance name or core name designated by the USAN Council.
  • Look similar to or be mistaken for the name of a currently marketed product.
  • Be too similar to any other product’s suffix designation.1

According to the FDA, the identified naming conventions are designed to “facilitate safe use and protect the safety of patients,” and work to reduce inadvertent substitution while maintaining consumer confidence through the use of a common core nonproprietary name shared with the reference product or other biosimilars approved under the reference product.

3) We also have our first “follow-on biologic.”

If you check out the list of European biologic products available through the Generics and Biosimilars Initiative website, you’ll notice they have Abasaglar, a biosimilar version of insulin glargine, included on the list of approved biologic products. It’s important to note that Eli Lilly’s insulin glargine has also been approved in the United States, but they aren’t calling it a biosimilar. Lilly’s insulin glargine, branded Basaglar in the United States, was approved under the FDA’s 505(b)(2) application pathway, a form of the New Drug Application that allows for approval of follow-on agents that don’t meet the criteria for the 505(j) ANDA pathway. Even though insulins are synthesized in living tissue (like other biologic products) they’re regulated under the Federal Food, Drug and Cosmetic Act along with hormones such as glucagon and human growth hormone, where-as other biologics and biosimilars are regulated under the Public Health Service (PHS) Act. These products are licensed under pathways defined by sections 351(a) and 351(k) of the PHS Act. Pharmacists need to be aware that follow-on products, such as Basaglar, aren’t deemed interchangeable with their reference products. Therefore, if a patient is to be switched over to Basaglar from Lantus, the pharmacist will need to obtain a new prescription for that patient.

4) Guidance on interchangeable biologic products is expected to be proposed by this December.

This past week the FDA confirmed that the long-anticipated guidance on interchangeable biologic products should be released before the end of 2016. Interchangeable products, unlike biosimilar products, are authorized under the Biologics Price Competition and Innovation Act to be substituted for a reference product without the intervention of the prescriber. This could provide an edge for products that meet the FDA’s standards for this form of approval through more-seamless access for patients.

Even in the current absence of the interchangeable pathway, pharmacists and prescribers should be ready to start transitioning their patients from reference products to their biosimilar alternatives as early as 2017. Several pharmacy benefit managers and health payers are already announcing formulary decisions that prefer these less expensive alternatives, which means health care providers will be under pressure to make accommodations for patients to allow them to reap the economic benefits these new products offer to patients.


1. Nonroprietary Naming of Biological Products — Draft Guidance for the Industry. August 2015. FDA website. Accessed October 30, 2016.

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