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“I can remember the exact moment when I decided to become a pharmacist,” said Sonia T. Oskouei, vice president of biosimilars at Cardinal Health. “It was during a career day in middle school; a pharmacist came in to talk with us about her work. With a mortar and pestle, she crushed a tablet and turned it into a liquid. Of course, now I know that it was a chemical reaction, but at the time, it seemed like magic. I remember thinking, ‘What a cool profession.’ To be an expert in medicine seemed like a superpower. That feeling has just continued to grow all my life: Medicines can do amazing things.”

Since earning her Doctor of Pharmacy degree, Oskouei has gained deep expertise in biosimilars, medications that are highly similar to U.S. Food and Drug Administration (FDA)-approved biologics – the fastest growing class of drugs in the U.S., bringing innovative, life-changing treatments to patients with cancer and chronic diseases. Unlike conventional medicines, which are made from chemicals, biologics are made from living organisms like animal cells, bacteria and yeast. Due to the complexity of manufacturing these products, biologics are also very expensive, which can impact patient access.

Because biosimilars provide the same treatment benefits as their original biologics – called reference products – by bringing more competition to the market, they help lower costs and increase patient access to treatment.

At Cardinal Health, Oskouei leads the biosimilars strategy, leveraging an enterprise perspective to maximize the value of biosimilars to help enhance patient access, improve outcomes and lower health care costs. “Leading a biosimilars strategy is really leading an overall health care strategy,” she said. “One of the most exciting promises of biosimilars is fueling innovation. By bringing competition to the market, and lowering health care costs, you essentially enable the investment necessary to pave the way for the next generation of critical treatments, which we are all rooting for.”

Prior to joining Cardinal, Oskouei was vice president of innovation and digital health at Premier Inc. where she also led a national biosimilars strategy on behalf of 4,000 hospitals and 175,000 other providers. In that role, she would architect, design, and lead business development initiatives with life science companies to ultimately drive evidence-based care and enable improved population health. Earlier, as a practicing pharmacist with Novant Health, she led corporate pharmacy purchasing and procurement.

“My interest and passion for biosimilars started from managing drug and biologic costs at Novant,” she said. “I am passionate about patient-centered care; I feel driven to help advance equitable access. At Novant, it quickly became evident that the costliest treatments were represented by biologics. So, when the first biosimilar was approved in 2015, it represented one of the first key milestones to bringing competition – and lower costs – to these critical treatments. There is a good chance that nearly everyone, whether personally or through others, knows someone who is burdened by a condition that requires biologic treatment. I realized early that biosimilars are a win, win, win: Good for health care institutions, good for the overall health care delivery system, and most importantly, good for patients.”

Indeed, biosimilars are projected to deliver nearly $133 billion in savings in the U.S. by 2025, according to the Association for Accessible Medicines (AAM).

2021: A year of progress for biosimilars
“I am deeply encouraged by the advances we’ve made in the U.S. over the last couple of years,” Oskouei said. “The first approved biosimilar was launched in 2015, and now, there are 35 FDA approved biosimilars; 21 of them are on the market.”

Significant progress in biosimilar adoption has been made in oncology, where all three classes of therapeutic oncology biosimilars now exceed 60% market share. “Savings from biosimilars increased to approximately $8 billion in 2020 alone,” Oskouei said.

Considerable achievements of 2021 are bringing greater competition for some of the costliest biologic treatments on the market, and beginning to drive meaningful cost savings:

• The first interchangeable biosimilar was approved in the U.S. The FDA approved the first interchangeable biosimilar in the U.S. for Viatris’ Semglee (insulin glargine-yfgn). Semglee is the first interchangeable biosimilar, the first biosimilar in diabetes care and the first biosimilar that is primarily dispensed at retail pharmacies. This is a significant step in expanding the opportunity to bring lifesaving treatment options for the millions of Americans who live with diabetes and are dependent on insulin – which continues to be among the costliest treatments for diabetes patients. And it has positioned retail pharmacists to play an essential role in educating patients and helping ensure clinical confidence in biosimilars.
   
• The first ophthalmology biosimilar was approved in the U.S. The FDA approved Biogen’s Byooviz (ranibizumab-nuna), the first ophthalmology biosimilar to treat retinal conditions including wet age-related macular degeneration (AMD) – the world’s leading cause of blindness in older adults. The National Eye Institute predicts the number of AMD cases will more than double by 2050. With an average per-patient annual cost of $2,000 per treatment, the biotech industry is focused on developing more effective AMD therapies and delivering treatment options that lower the cost of care.
   
• The first Humira (adalimumab) biosimilar achieved interchangeability designation in the U.S. In October, Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) was granted interchangeability status for Humira, a treatment widely used in the management of autoimmune conditions like rheumatoid arthritis, psoriasis and Crohn’s disease. Cyltezo is now one of seven FDA-approved adalimumab biosimilars that are lined up to hit the market in 2023. Competition is expected to be fierce, Oskouei said. “Though Cyltezo is the first adalimumab biosimilar to achieve interchangeability status for Humira, it’s not going to be the last. Humira is the number-one selling drug in the world – and comes with the most extensive list of biosimilar candidates. Bringing adalimumab biosimilars to the market will be one of the most significant events to impact health care costs in the U.S. in recent history.”
   
• Regulatory activities brought greater attention to biosimilars. President Biden signed into law two bipartisan bills aimed at reducing prescription drug prices and addressing some key barriers to biosimilar adoption: The Ensuring Innovation Act and the Advancing Education on Biosimilars Act. The first is intended to limit the ways in which market exclusivity is granted to reference biologics, with the goal of closing potential loopholes that can delay competition and accessibility to lower-cost alternatives, including biosimilars. The Advancing Education on Biosimilars Act is intended to strengthen provider and patient confidence in biosimilars through enhanced educational efforts – which will help increase the use of biosimilars and ultimately lower health care costs.

Enhanced education efforts are critical to continued acceptance and use
“As market research continues to show, there are still many knowledge gaps among certain physicians, pharmacists, patients and caregivers when it comes to biosimilars,” Oskouei said. “Challenges remain across all biosimilars, but especially within the rheumatology space, where hesitation and barriers are further reflected in much slower adoption rates thus far.”

Oskouei explained that there are multiple considerations for biosimilar adoption in the U.S., and each product’s performance is influenced by a multitude of factors, including the number of competitors, provider acceptance, treatment type, reimbursement model and payer landscape, and others. “While education is not the only factor impacting biosimilars adoption, it is a significant contributor. We need to address the knowledge gaps in order to enable the very first step of biosimilar utilization, which is a willingness to prescribe.”

Part of the challenge is the name itself, she said. “People hear ‘biosimilar’ and think, ‘Similar? I don’t want something similar. I want exactly the same medication.’ But the very nature of biologics, which includes biosimilars, means that every batch is going to be slightly different – pointing to the need for greater foundational understanding of biologics as a whole.”

The more providers know about biosimilars, the more clinical confidence they can develop to prescribe them, she said. The more clinically confident the provider is with biosimilars, the greater likelihood that patients will feel comfortable with biosimilars and view them as safe and effective treatment options.

“Education – for providers, pharmacists, patients and caregivers alike – is a huge area of opportunity.”

Advancing the promise of biosimilars
“I’ve taken what some may consider a nontraditional path as a pharmacist – and that has allowed me opportunities to advance biosimilars’ promise. And, as an advocate of the profession, I love seeing more and more pharmacists enter nontraditional roles, where their unique qualifications can bring an important lens to the overall health care delivery system,” Oskouei said. “For me, being in newly created positions and having the opportunity to innovate throughout my career has been a gift, because I love pursuing the unknown and undefined, and having the opportunity to push things forward – all with the aim of serving patients and improving health outcomes, which is what energizes me most about what I do.”

Much has already happened in the biosimilars space, she explained. “But in the U.S., we’re really just at round one. Much more is on the horizon, with a strong pipeline of biosimilars that will further seek to enhance affordability and accessibility of biologics for many more patients with debilitating conditions.

“We have tremendous opportunities to push this segment forward, to the benefit of everyone: health care institutions, the overall health care delivery system, and patients alike.”

Editor’s note: Oskouei holds a Doctor of Pharmacy degree from Belmont University in Nashville, Tennessee, and is a Board Certified Medical Affairs Specialist (certified by the Accreditation Council for Medical Affairs). She is an established thought leader with numerous publications and currently serves on the Board of Advisors for the Center for Biosimilars. She is a lead author of the 2022 Cardinal Health Biosimilars Report: The U.S. Journey and Path Ahead, which brings together provider survey results and the latest market data on biosimilar utilization and payer coverage, along with perspectives from leading physicians and industry experts. You can download a free copy of the report here.