Biosimilar Policy Roundup: May 2022

May brought a number of biosimilar policy updates of all types, including updates on British Columbia’s switching program, a new bill that could revamp biosimilar user fee programs, and insight into how companies are shaping their environmental policies around biosimilars.

United States Federal Policy

One big announcement was the congressional introduction of HR 7667, also known as the Biosimilar User Fee Amendments of 2022. If signed into law, the bill would expand FDA user fee programs for prescription drugs and medical devices, including biosimilars and generics. The bill was referred to the House Committee on Energy and Commerce, which voted unanimously to advance the measure.

Experts, including an editorial board member for The American Journal of Managed Care®, a sister site for The Center for Biosimilars®, also weighed in on some existing policies. Stacie B. Dusetzina, PhD, the Ingram Associate Professor of Cancer Research at Vanderbilt University Medical Center, called for Medicare policies to be modified to ensure that out-of-pocket costs for seniors are controlled or capped, especially as more high-cost cancer medications are added to Part D program formularies, including biologics and biosimilars.

Researchers presented findings of how small molecule drugs reclassified as biologics, such as insulin products, under the FDA’s rule change in 2020 impacted Medicaid spending at the Academy of Managed Care Pharmacy (AMCP)’s annual meeting. They found that if the change had gone into effect 10 years prior, Medicaid could have saved $4.5 million in gross reimbursement costs.

International Policy

Canada’s policies came under fire a bit after a report called for policy makers to proceed with caution when establishing new policies to boost biosimilar utilization and savings. Although most Canadian provinces have policies that favors biosimilars or list biosimilars on formularies, not all policies place biosimilars at full benefit or encourage biosimilar use over the originator. Some patients and providers expressed concerns regarding indication extrapolation, and the report authors called for a more united policy front and more biosimilar education.

On the bright side, British Columbia’s policy switching patients with rheumatic conditions taking Remicade (reference infliximab) to a biosimilar was found to be safe and tolerable for patients after the first year of the program. British Columbia was the first Canadian province to implement a biosimilars switching policy, which started in 2019.

Additionally, the United Kingdom’s Medicines and Healthcare Regulatory Agency approved Teva Pharmaceuticals ranibizumab biosimilar (Ongavia) referencing Lucentis for the treatment of ophthalmic conditions. The United Kingdom is the first European country to approve the biosimilar and Ongavia is the second ranibizumab biosimilar to be approved. The United Kingdom has had to slightly shift its policy and regulatory structures after leaving the European Union, a move dubbed globally as Brexit.

Practice and Business Policy

In a contributor piece, Jeff Patton, MD, CEO and board member at OneOncology, explained the controversial role that pharmacy benefit managers (PBMs) play in formulary decision-making and how policy changes to empower physicians and patients and reduce PBM influence could encourage greater biosimilar utilization and create savings for health care systems.

A look at the trend of drug companies establishing environmental, social, and corporate governance frameworks revealed that companies are citing biosimilar development as an example of their efforts to be more eco-friendly and globally sustainable. Biosimilars offer environmental and societal benefits by enabling patients to have access to life-savings medications for a more affordable price and by being biologic drugs, which are overall more environmentally friendly to produce compared with small molecular drugs.

Prime Therapeutics saw its expenses cut by 26% during the first year of its MedDrive program, a medical drug management policy that leveraged biosimilars to reduce high drug costs for its beneficiaries enrolled in any of Prime Therapeutics’ Blue Plans. The program improved Prime’s contracts with drug manufacturers and recommended the use of lower-cost drugs, including biosimilars and generics, to patients requiring treatment with oncology medications.


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