Biosimilars Policy Roundup: October 2022

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October ushered in a number of policy updates, including the implementation of a biosimilars switching policy, the European Union declaration of biosimilars as interchangeable, and the reauthorization of the Biosimilars User Fee Act.

October ushered in a number of policy updates, including the implementation of a biosimilars switching policy, the European Union declaration of biosimilars as interchangeable, and the reauthorization of the Biosimilars User Fee Act.

National Policies

The most recent policy news this month has been the implementation of a biosimilars switching policy in Saskatchewan, Canada, the sixth province and seventh jurisdiction to do so. The policy would allow for reference products to be switched out for biosimilars automatically, which will lead to lower drug costs for the province’s public health plan.

The news came after Biosimilars Canada, a national association representing the Canadian biosimilar industry, called for Ontario, another province, to implement a similar policy. The Ontario government approved a policy in 2020 but hasn’t implemented it yet. According to Biosimilars Canada, the Ontario government could save $147 million annually by implementing a switching policy.

In the European Union, the European Medicines Agency (EMA) declared that biosimilars are interchangeable with originator products. In a recent column piece, Sarfaraz K. Niazi, PhD, a professor and biosimilar advocate, applauded the EMA’s decision and recommended that the United States do the same.

In the United States, President Biden reauthorized the Biosimilar User Fee Act, which enables the FDA to assess and collect fees for biosimilars for the next 5 years. The law ensures that the FDA has a stable source of funding between 2023 and 2027 to continue developing the biosimilar industry. The news came after months of advocates and industry leaders pushing for it, including representatives from the Biosimilars Forum, the Biosimilars Council, and the Association for Accessible Medicines.

Additionally, Congressional leaders introduced HR 8877, the Biologics Competition Act of 2022, a bill that would make interchangeable biosimilars more accessible for US patients. If signed into law, HR 8877 would task HHS with assessing current challenges to substitution of biosimilars and interchangeable products and sharing it with Congress. The hope is that the results can aid Congressional leaders with identifying policy solutions that can increase public trust in interchangeable biosimilars and remove barriers to their utilization.

How Policy Influenced the Market

Policies that have encouraged biosimilar use have led to significant savings for the United States, accumulating $21 billion in savings in 6 years, according to Amgen’s new edition of its Biosimilar Trends Report.

The report examined how the US biosimilar industry has developed since 2015, including current market trends, predictions for the next few years, and insight into how reimbursement and other policies could develop going forward. The report also offered advice on how clinicians, patients, and other stakeholders can prepare for more biosimilars to enter the market.

Amgen’s report noted the success of the FDA’s Biosimilar Development Program, which has continued to grow despite a slowdown because of the COVID-19 pandemic. In 2019, the program had 77 projects; in 2022, there are 96.

Clinic Policies

Panelists during a LinkedIn Live event called for all stakeholders to work together to implement education policies, provide clarity on interchangeability, and encourage adoption of ophthalmology biosimilars. The panelists provided an overview of why the FDA decided to grant an interchangeability designation for an ophthalmology product even though the label will not impact dispensing procedures for the drug and the ramifications of that decision on a clinic level.

A podcast episode featuring Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, discussed the stresses that practices face when trying to manage biosimilars, including some policy considerations that administrators could implement to address them and prepare for more biosimilars entering the market and being added to formulary lists.

During an interview at a recent Institute for Value-Based Medicine® event, Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services at Emory Healthcare and Winship Cancer Institute, explained some strategies that health care institutions can implement to improve biosimilar adoption rates.

His biggest piece of advice was taking into account barriers of individual institutions and recognizing how they are different from each other, such as whether they use electronic medical records, the general provider awareness of and confidence in biosimilars, the structure of the finance team, and whether a pharmacy and therapeutics policy is already in place.

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