Update

Delaware governor signs new biosimilar law requiring prescriber notifications

By Zachary Brennan

- Last updated on GMT

Related tags: Federal trade commission, Food and drug administration

Delaware governor signs new biosimilar law
US states continue to form disparate views of how to deal with biosimilars as Delaware Governor Jack Markell (D) signed into law last week a bill that would require pharmacists to notify prescribers if a biosimilar is substituted for a biologic.

The law​ - which was praised by industry group BIO, who framed it as a law that grants patient access to biosimilars - does more than just allow biosimilars to be dispensed. Following its passage,  pharmacists in Delaware will have 10 days to notify prescribers if a patient’s treatment is switched to a biosimilar and provide the name of the manufacturer.

Previous versions of the bill also went so far as to call on pharmacists to notify patients in writing that the biosimilar has been FDA approved, and keep a record of the substitution for at least three years.

Jim Greenwood, BIO’s President and CEO, said regarding the new state legislation from Delaware: "Interchangeable biologics are not generics. Even slight changes to a biologic drug can change its properties entirely…Unlike conventional generic medicines, interchangeable biologics are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same. Those suggesting interchangeable biologics and generics are the same are wrong​."

Biosimilars approved and used in the EU​ and elsewhere have yet to lead to any issues regarding interchangeability.

Other States

Critics of these types of state notification laws, which have passed in Oregon, Utah, Virginia and North Dakota​, note that the onerous requirements placed on pharmacists could hinder biosimilar substitution and thereby drive up costs for patients.

The varying state legislation, which appear at face value to be industry-driven, comes before the US FDA has yet to approve any biosimilars.

Bruce Leicher, SVP of Momenta, previously said at an FTC (Federal Trade Commission) workshop on biosimilars​ that much of the state legislation is part of a campaign against biosimilars that seeks to restrict their access.

Other states, however, such as Michigan and Massachusetts, have proposed and ratified bills that allow pharmacists to switch biosimilars for biologics once approved, but do not create any new notification requirements for pharmacists.

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