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Biosimilar Regulatory Roundup: September 2020


September saw several biosimilar regulatory advances despite 2020 being a slow year for biosimilar approvals and launches.

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.

Other US Regulatory News

Recently, Congress has urged the Federal Trade Commission (FTC) to investigate anticompetitive practices in the pharmaceutical industry more closely, especially those in regard to biosimilars, according to Markus H. Meier, acting director for the FTC’s Bureau of Competition.

Meier, who presented at the American Conference Institute’s 11th Summit on Biosimilars & Innovator Biologics, said that the agency has taken a bigger role in reviewing patent settlement agreements to see if reference biologics companies are going too far in preventing free market activity by claiming that potential competitors are committing patent infringement.

Subsequently, a report from the Center for American Progress disclosed several ways that the current or future president can take immediate action to lower drug costs without the need for new legislation.

Among the powers that the president already has at his disposal, the Bayh-Dole Act grants the federal government the power to ensure affordable prices of drugs developed through federally funded research.

Additionally, the federal government has the power to issue licenses, without having to get permission from a patent holder, to additional drug manufacturers to produce a product in order to increase capacity and lower drug prices.

International Regulatory News

In the United Kingdom, regulators attempted to make the argument that comparative biosimilar efficacy trials are unnecessary to demonstrate that drug candidates are equivalent to reference products in a new paper.

They suggested that in-depth knowledge of the safety, efficacy, and immunogenicity profiles of the reference product should already aid in predicting potential issues with a biosimilar. Also, technology advancements and analytical tests already make it easier to detect differences between a biosimilar and a reference product.

In Canada, Merck’s etanercept biosimilar (Brenzys) was granted additional indications to include plaque psoriasis, psoriatic arthritis, and juvenile idiopathic arthritis.

Originally, Brenzys was approved by Health Canada in 2016 for the treatment of moderate-to-severe rheumatoid arthritis in adults and ankylosing spondylitis. Its reference product, Enbrel, already has already been approved for all of the above indications in Canada.

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