POCP Blog

By Connie Sinclair, Director, Regulatory Resource Center

Biosimilars are starting to enter the market in the United States and are generating interest because of their significant cost-savings potential and patient care implications. Biosimilars are to biological drugs as generics are to conventional drugs. Even though biosimilars are very new to the US market (the first was launched domestically in 2015, and the second just recently), states already are concerned about their impact on patient safety. In response, nearly two-thirds have enacted — or are considering enacting — legislation on how prescribers can prohibit substitution as well as require the pharmacy to notify the prescriber that a substitution has been made. The reason: the drug that was prescribed is not necessarily identical to what was dispensed. This has patient safety considerations when it comes to biosimilars.

Biologic drugs are made from living organisms and are different in chemical composition than conventional medications, typically developed after the original biologic goes off patent. They mimic the activity of the biologic, but by nature are not exactly the same. For this reason, the physician needs to know which biosimilar product was dispensed so that outcomes and adverse reactions can be tracked. EHRs and Pharmacy system vendors, take note. This will require a new type of interoperability than what is in practice today. Incidentally, one state has recently passed an unrelated opiate statute that also requires a dispensing notification from the pharmacy to the prescriber.

State legislative rundown. As of the publication of this blog, 19 states and Puerto Rico have enacted biosimilar substitution legislation. The legislation generally follows the same basic model, as described below, although there are some differences.

Most legislation requires prescriber notifications to include drug product name and manufacturer. The notification must be done electronically through the prescriber’s electronic health record (EHR), although fax, phone or other means may be used as a backup if the EHR is offline for some reason. Passed legislation does not require the biosimilar lot number to be included in the prescriber notification, however, this is recommended and may be reflected in future bills. There is variability among the states as to the window for notification, such as 48 hours versus 5 business days. A popular provision requires the pharmacist and the physician to retain records of substituted biosimilar medications. Eight states have pending legislation. There could be movement among the remaining states as biosimilars continue to capture legislators’ attention.

Going forward. The time is right for the range of stakeholders to address the opportunities and challenges created by the entrance of biosimilars in the United States. This landscape will rapidly evolve, which makes it imperative that stakeholders keep current with what is legal in their respective states and markets when it comes to biosimilar substitution. Check out our regulatory resource center, which makes it easy for you to keep up with state and federal regulatory actions related to biosimilars. I’m happy to give you an overview and explain the value proposition for your situation. Call me at 404-915-2881, or email me at connie.sinclair@pocp.com.  

• Post Categories
• Biosimilars
• EHRs
• Regulatory Trends