States wade into disclosure rules on biosimilars

Washington As the Obama administration continues work on an approval process for biosimilars, physician organizations have advocated that any state legislation on the issue contains language that adequately notifies prescribing doctors in the event an original biologic is substituted with a biosimilar product.

Biosimilars essentially are copies of biologics, which the Food and Drug Administration describes as products conceived from large, complex molecules and that may include blood and blood components, gene therapies and vaccines. From a clinical standpoint, biosimilars are not supposed to be meaningfully different from the original biologics from which they were based.

The FDA has indicated it has yet to license “a biological product as ‘biosimilar’ to an FDA-licensed reference product,” although the Affordable Care Act granted the agency the authority to develop an approval process for biosimilar products. The agency has issued several draft guidance documents on biosimilar product development, as well as industry guidance in late March that addressed formal meetings between biosimilar product sponsors or applicants and the FDA. It has yet to finalize official guidelines on interchangeable biologics.

No timeline has been set for issuing the final guidance, said FDA spokesman Stephen King. In the meantime, the agency has been meeting with companies to discuss product development of these medicines. In the event companies want to submit applications for biosimilars, the FDA is “open for business,” he said.

As the FDA develops its official approval pathway, several states have considered their own bills that would set parameters on biosimilar products. The Assn. of State and Territorial Health Officials reported that three states — North Dakota, Utah and Virginia — have approved such laws. At this article’s deadline, a bill approved by Florida’s Legislature was awaiting the signature of Gov. Rick Scott.

Physician organizations in several states have stressed the importance of physician notification requirements in these types of bills. “It is imperative that a physician be made aware of any substitutions to a patient’s medications in order to properly monitor the patient’s reactions,” Russell Libby, MD, the Medical Society of Virginia’s president, wrote to Gov. Bob McDonnell in February. Virginia was the first to enact a biosimilars substitution bill. Although the law included a process for notifying prescribers, that provision sunsets in 2015.

Notification requirements vary

North Dakota’s law outlines how both doctors and patients should be notified in the event a biosimilar product is substituted for a prescribed biologic. Pharmacists would have to notify the prescribing practitioner within 24 hours of substituting a biosimilar product for a prescribed product, either in writing, by word of mouth or through electronic transmission. In the law’s other provisions, the FDA would have to determine that the biosimilar was interchangeable with the prescribed product before it could be substituted in such a way.

The notification provisions have received criticism from some industry sectors. Courtney Koebele, executive director of the North Dakota Medical Assn., said pharmacy benefit managers in the state opposed the law because they saw it as an impediment to prescribing less costly biosimilar products. She said, however, that her association supported the bill “because biosimilars are not the same as generics,” and because it contained additional protections to support patient safety. The association would have supported the bill only if physician notification were retained, she said.

Florida’s legislation originally had a provision to alert prescribing physicians within five days of a biosimilar substitution, but lawmakers eventually took out that provision.

The Generic Pharmaceutical Assn., which represents distributors and manufacturers of finished general pharmaceutical products, said the requirements for notifying doctors were burdensome because they went beyond current substitution practices for prescription medications, and the association supported its elimination from Florida’s bill. The group said the language was based on an approach sought by biotechnology companies Amgen and Genentech, which other states such as North Dakota used as the template for their own legislation. In GPhA’s view, this approach would create barriers to consumers obtaining access to biosimilars.

Thomas Felix, MD, director of Amgen’s global regulatory affairs and safety group, said the omission of this provision in the Florida law “is a loss for patients, as now patient medical records may not reflect the actual medicine administered to the patient.” The Florida legislation did retain other provisions the biotechnology companies have supported, he said.

In a statement, Amgen said it supported the development of a “clear process for substitution of interchangeable biologics so that patients will have increased access to biologic medicines. Amgen believes it is important that we distinguish biologics (e.g., injectables) from traditional chemical medications (e.g., pills), especially given that biologics have the potential for delayed adverse events and that may prove challenging to attribute to a particular product. … State substitution laws for biosimilars should include basic patient safety protections that ensure physicians are fully informed with respect to their patients’ treatment.”

Florida’s doctors would have preferred that the notification provision had remained in the bill, said Erin VanSickle, vice president of communications and marketing with the Florida Medical Assn. “However, it is important to note that the physician retains the ability to mandate that the prescription be filled as written.”

The American Medical Association has supported an official approval pathway for biosimilars, but it also has urged that any substitution of a biosimilar be limited to a biologic that the FDA has approved as interchangeable, and only in situations in which the doctor has not indicated a preference for the original product.