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Despite the United States have a lower number of biosimilar approvals and launches throughout 2020, regulators have not slowed down in trying to expand biosimilar utilization as a way to lower costs and increase access to care for patients.

New Legislation

In early September, Representative Glenn Grothman, R-Wisconsin, introduced in Congress a bill that would waive interchangeability requirements for biosimilar insulins.

Current FDA guidance says that manufacturers must obtain data from switching studies, in addition to the data required to receive regulatory approval, in order for biosimilars and biosimilar insulins to be filled at the pharmacy, in place of more expensive reference products, without needing physician authorization.

Grothman told The Center for Biosimilars® in an interview that the bill’s focus on biosimilar insulins is easier for other congressional leaders to get behind because insulins’ already have an extensive catalogue of evidence on the safety of switching between products. He also said that the legislation could lead to more biosimilar legislation in the future.

Additionally, The FDA moved forward with implementing controversial plans to allow importation of prescription drugs, including biologics and insulins, from Canada as a way to bring down drug costs in the United States. The Safe Importation Action Plan was developed in response to the prescription drug executive orders signed by President Donald Trump earlier in the year.

However, in an interview with The Center for Biosimilars®, Wayne Winegarden, PhD, a senior fellow in business and economics at the Pacific Research Institute (PRI) and director of PRI's Center for Medical Economics and Innovation, called the plan a terrible idea as it increases the likelihood that dangerous counterfeit medication will unknowingly end up on the US market.

Towards the end of the month, California became the first state to implement a policy to produce and distribute its own line of biosimilars, biosimilar insulins, and generic drugs with the signing of SB-852.

Under the newly enacted law, the California Health and Human Services Agency is able to form partnerships with drug manufacturers and suppliers that would aid in producing and distributing biosimilars, generics, and insulin products to help lower drug costs and increase market competition.