Biologics vs. Biosimilars: The Differences and Why They Matter

Advances in pharmaceuticals continue to evolve – quickly – helping to better treat complex health conditions, such as cancer, multiple sclerosis, and hemophilia. Two types of pharmaceuticals continuing to grab headlines are biologics and biosimilars.

Where biologics have been around for over one hundred years, making their debut in the 19th century, biosimilars are newer to healthcare, with the first globally-approved biosimilar making its premiere in the EU in 2013 and the U.S. Food and Drug Administration (FDA) approving the U.S.’s first biosimilar product two years later.

There’s no doubt that biologics have changed the way we prevent, diagnose and treat medical conditions and diseases.  However, biosimilars “have the potential to enhance treatment accessibility,” according to Pfizer.  Additionally, with many biologics’ patents about to expire, pharmaceutical companies are facing an interesting crossroads when it comes to biologics and biosimilars.

But, before we get to the future of medicine, let’s take a look at biologics vs. biosimilars.

What Are Biologics?

Many biologics have been around for over one hundred years with the emergence of vaccines, such as those for rabies, typhoid, and smallpox.  Fast forward to 1982, and human insulin became the first FDA-approved bacteria-generated biologic. And, recently, the FDA approved the Moderna COVID-19 vaccines for booster doses on March 29, 2022. 

These types of drugs – commonly referred to as biologics – are produced using a living system, such as components from plants, animals, humans, and microorganisms. Biologics contain more complex molecules than small molecule drugs, like aspirin or antihistamines. Often, biologics are administered through injection or infusion.

What is an example of a biologic? 

In addition to many vaccines, here are some other biologic uses to keep in mind:

  • Gene therapies
  • Tissues for transplants
  • Blood products, such as platelets
  • Recombinant proteins, such as insulin
  • Stem cell therapies
  • Monoclonal antibodies that help the immune system treat autoimmune diseases or fight cancer

According to a recent study, the global biologics market is expected to reach $749.62 billion by 2028. 

What Are Biosimilars?

As we mentioned above, biosimilars are newer to the pharmaceutical market.  But, these drugs have already made a big impression during this short tenure. 

A biosimilar is a biological product, serving as an almost identical copy to the FDA-approved original biologic product.  This original biologic product is referred to as a “reference product.”  

The biosimilar product must not have any meaningful differences in terms of quality, effectiveness, and safety from the reference product. Only minor variations in clinically inactive components may exist. 

Source:  FDA.

Biosimilars may be put into the market once the patent expires for the reference product (i.e., the biologic product copied by the biosimilar).  If biosimilar manufacturers put the drug into circulation while a biologic’s patent is still effective, then the biosimilar manufacturer runs the risk of violating the active patent.

What is an example of a biosimilar? 

Let’s look at some examples of FDA-approved biosimilar products.

Humira is a popular brand name drug primarily used to treat rheumatoid arthritis and Crohn’s disease. However, Humira frequently tops the list for the most expensive drugs with a $9,065 average monthly cost. Since the drug’s debut in 2014, the manufacturer’s cost has increased by 138 percent.

Additionally, Humira makes patient access difficult since most health plans place this drug in higher-tier formularies – with higher copays and prior authorization requirements. 

Over the past few years, however, several Humira biosimilars have been approved by the FDA, including:

  • Yusimry, approved in December 2021
  • Hulio, approved in July 2020
  • Yusimry, approved in November 2019
  • Hadlima, approved in July 2019
  • Hyrimoz, approved in October 2018
  • Cyltezo, approved in August 2017
  • Amjevita, approved in September 2016

As reported by the Kaiser Family Foundation, biosimilars provide approximately a 30 percent savings over brand biologics; however, biosimilars have “the potential to reduce spending by more than $100 billion dollars” through 2024.

Are you looking for ways to predict how biosimilars will affect your drug spend? Xevant can help.  Contact us today to learn more.

Are Biosimilars the Same as Generic Drugs?

While biosimilars and generic drugs are versions of a brand name drug, and often more affordable than that brand name drug, they are not the same. 

Biosimilars and generic drugs are both approved by the FDA, but through different clinical trials and approval processes.  For example, generic drug manufacturers must prove that they are chemically identical to the brand name drug, demonstrating that the generic is essentially the “bioequivalent” of the brand name drug.

Biosimilars, on the other hand, are not chemically equivalent as they contain components from living organisms. Like generics, biosimilars still require testing and approval by the FDA.  However, they are typically more expensive than generics, but less expensive than the reference product (or brand name drug). 

What Is a Biosimilar Interchangeable Product?

Now that biologics vs. biosimilars has been covered, let’s take biosimilars a step further.  Biosimilars may be interchangeable with the brand name drug, or reference product, if the biosimilar meets additional requirements.  These requirements are outlined in the Biologics Price Competition and Innovation Act

To be interchangeable, a “manufacturer of a proposed interchangeable product will need to provide additional information to show that an interchangeable product is expected to produce the same clinical result as the reference product in any given patient.”  As a result, according to the FDA, a product approved as an interchangeable biosimilar “means that the FDA has concluded it may be substituted for the reference product without consulting the prescriber.”

So, for example, suppose a patient self-injects a drug for rheumatoid arthritis.  To originally receive the biosimilar instead of the brand name drug, they would need a prescription from their doctor.  However, once a biosimilar interchangeable drug is approved by the FDA, then the pharmacist could substitute the interchangeable biosimilar for the brand name drug without consulting the patient’s doctor.

What’s Next? The Future of Biologics vs. Biosimilars

As we continue to see rising drug prices, the future of biosimilars is bright. With biosimilar sales topping $15 billion in 2020, the industry is expected to grow rapidly – doubling in size to $30 billion by 2025 and doubling again to $60 billion by 2029. 

However,  the difference between biologics vs. biosimilars continues to develop, and with this growth pace, expect change in the clinical, manufacturing, regulatory, and commercial markets as well as in research and development. But through increased competition, decreased overall cost, and increased access and utilization for patients, biosimilars just may be the thing that the healthcare industry needs.

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Ashwin Patel

SVP, Data

Ashwin (Ash) has more than 20 years leadership experience in data warehousing and business intelligence practices within the healthcare sector. At Xevant, Ash leads the data and business intelligence teams and is responsible for future state expansion of Xevant data technology platforms and processes, partnering with the organization’s product teams to develop best-in-class products and solutions. Prior to Xevant, Ash was VP Business Intelligence for HealthSmart Benefit Solutions based in Irving, TX, a third-party administrator (TPA) of medical, pharmacy, and clinical data. Ash earned a Bachelor of Science degree in computer science and operations research from Leeds Becketts University in Leeds, England.

Sahily Paoline

Chief Pharmacy Officer

Sahily is a licensed pharmacist and expert business leader with more than 20 years of experience delivering high-quality clinical care, building and leading organizations, and staffing and motivating teams in the pharmaceutical and digital health industries. Sahily specializes in Clinical Program Management, Pharmacy Practice and Operations, and building and growing business. She is passionate about the use of data and technology in patient care and believes in a holistic approach to healthcare.

Megan Foster

Manager, People Operations

Todd Rode

VP, Revenue Operations

Todd served as an Artillery officer in the U.S. Army before a disability turned his focus to the business world. He’s carried a bag, led multiple sales operations and sales development efforts, and run a sales team in complex selling environments. The son of small business owners, Todd enjoys helping business leaders grow by using proven, repeatable processes. He holds a BS from the United States Military Academy at West Point and an MBA from the Kellogg School of Management at Northwestern University. Todd lives in Nashville with his wife. He spends as much time outside as possible and co-founded a brewery in 2019.  He’d love to tell you the full story over a pint sometime.

Marvin Roi Elvambuena

Software Development Manager

Marvin is responsible for all aspects of software development efforts at Xevant, including architecting and managing software solutions from the ground up. He brings with him a performance history of leading loosely defined enterprise software projects in rapid changing environments. He has previously worked in several industries such as HR solutions, insurance, shared services, and payroll and holds a BS in Information Technology with specialization in Web Development.

Greg Abram

VP Sales

Greg is a results-driven sales professional with more than 12 years of experience in the PBM and healthcare markets. As VP of Sales, Greg leads the Xevant sales team focused on growing revenue and expanding market reach. Prior to Xevant, Greg served in multiple leadership and growth positions with Myriad Genetics, Navitus Health Solutions, Catamaran, and CVS Caremark Corporation. Greg’s passion to create long-lasting, aligned partnerships has delivered tremendous value for PBMs, health plans, large purchasing groups, and fortune 500 organizations throughout the country.

Jaylyn Palmer

Chief of Staff

Jaylyn is a dynamic Chief of Staff who thrives on helping create workplaces that go beyond the ordinary to achieve a culture of belonging, empowerment, and improvement. Proving to be a culture ambassador, strategic advisor, and relationship builder, Jaylyn supports the organization with versatility and innovation. When she’s not wearing one of her many Xevant hats, you can find Jaylyn planning a party, attending live music and theater, or playing Dungeons and Dragons.

Jeff Weber

Chief People Officer

Jeff has extensive experience building and growing positive organizational culture that supports high performance, transparency, learning and growth. Jeff has implemented comprehensive talent strategy including talent acquisition, engagement, rewards, and recognition programs. Prior to Xevant, Jeff was the EVP People and Places at Instructure, a rapidly growing provider of the Canvas and Bridge learning management platforms focused on transforming online learning and employee development.Jeff also led the growth of the people function for Ancestry.com. Jeff holds an MBA with an emphasis in Organizational Behavior from Brigham Young University.

Scott Sorenson

Chief Technology Officer

Scott is an expert business leader with extensive experience scaling technology organizations. His experience includes technology leadership roles at Cedar Health Payment Solutions, Human Longevity, Inc., and 16 years at Ancestry where he was the Chief Technology Officer and played an integral role scaling the Ancestry family history business that hosts billions of historical records and serves millions of customers. He also led their technology organization as they transformed the business to include a world class consumer genomics product line. At Ancestry, Scott prepared the technology organization for an IPO and multiple PE transactions.

Daniel Telford

Director, Corporate Treasurer

Daniel is a financial professional with more than 15 years of financial and management experience. Having worked in multiple demanding roles including Business Banker, Licensed Investment Professional and Financial Center Manager, Daniel uses his experience to guide and inform his current role as Corporate Treasurer for Xevant. Daniel has led multiple complex cross-functional teams to sustained success in the financial services industry.

Griff McGee

Corporate Controller

Griffin is CPA and finance and accounting professional with more than 10 years’ experience in public accounting, internal audit, and consulting. Throughout his career Griffin has worked with clients to solve complex problems, improve and implement new processes and achieve public company readiness. Prior to joining Xevant, Griffin served in several audit and consulting roles with Protiviti, Change Healthcare, Genesco and Decosimo, CPAs.
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Gerrit Lemmen

VP, Rebates

Gerrit is an experienced leader in the PBM, Specialty and Formulary rebate markets. As VP of Rebates at Xevant, Gerrit is responsible for managing drug rebates through Xevant’s revolutionary pharmacy benefits platform. In his previous roles at Magellan Rx Management, Gerrit led highly respected commercial rebate operations teams and focused on increasing efficiency that enabled scalability and growth.

Mike Simmons

VP, Product Management

Mike is a true product champion & ambassador with 18+ years of experience in critical product launch, strategic branding, and delivering profitable campaigns that capture market share and create growth. His vision and skills for implementing integrated, high-impact, go-to-market strategies have proven to drive increased sales and an overall improvement of marketing programs. Mike’s ability to leverage business savvy in order to align management, data intelligence, and content management generate more informed business decisions resulting in enhanced revenue for progressive, enterprise organizations.

Laura Phillipson

VP, Client Experience

Laura Phillipson is a client management expert with experience managing client services teams. Her past roles include Sr. Client Services Executive for Navitus and over a decade of experience as a Certified Pharmacy Technician. Laura’s career in client relations spans nearly two decades. An avid sports fan, Laura excels in helping clients create a strong strategy with a competitive edge. Laura’s extensive background in both customer service and the medical field provides an ideal blend to lead client management for Xevant.

Chad Davis

Director, Compliance

Chad is a credentialed and strategic audit and compliance professional with more than 10 years’ experience assisting companies with achieving their business objectives through adept governance, compliance, and risk management. Prior to Xevant, Chad served in several auditing and accountant roles for Protiviti, Intermountain Healthcare, and First Data Corporation. He is a credentialed CISM and CISA and holds a BS in Accounting.

Erin Glenn

Director, Data Warehouse

Erin is 20-year data warehousing and business intelligence technology leader who has conceptualized, designed, and implemented ground-breaking data-centric technology solutions. She has solved big problems, delivered operational efficiencies, and increased productivity and cost savings throughout her career by delivering enterprise class data warehouses and business intelligence solutions.  Prior to Xevant, Erin served in multiple technology leadership positions with Hampton Roads Transit, MSN, The Port of Virginia, and Innova Systems. She holds a bachelor’s degree from the University of Hawaii.

Greg Heaps

Chief Marketing Officer

Greg is an expert marketer and innovative business builder specializing in launching and building high growth companies. As a founding member and on the leadership team of multiple venture backed tech startups, Greg has extensive experience in numerous markets including software services, health and medicine, commercial real estate, and consumer focused products. His primary motivation is driving demand and growth through an omni channel, go-to-market strategy. When Greg is not neck deep building an exhilarating business, he can often be found mountain biking, fly fishing, or carving deep powder on remote mountains.

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Jace Garfield

Chief Analytics Officer

Jason (Jace) Garfield, MSW has thrived in many industries ranging from data and information technology to foster care and mental health management. In his role with the Utah State Justice Commission, he helped publish medical research on drug effectiveness. Jason’s passion for technology and data automation paved the way towards innovations in identifying new to market drugs, tracking systems to identify clinical interventions, and data automations, resulting in millions in operational cost reductions. At Xevant, Jace leads every aspect of product operations and is responsible for a diverse team of technology experts.

Jason Hardin

Chief Revenue Officer

With 20+ years of sales and sales management experience in SaaS sales and professional services, Jason is a dynamic, performance driven leader with an exceptional record of achievement in motivating sales teams to exceed quotas, while ensuring client success.  Having led many organizations in the start-up, high growth, and emerging phases, Jason brings an entrepreneurial hunger to the sales, client success, and business development organizations with the ability to penetrate new markets, produce high growth sales results, achieve adoption and retention goals, and grow market share and revenue quickly.  

Jeff Lininger

President & COO

Jeff is the Chief Operating Officer at Xevant and is accountable for operational excellence at the company. Prior to joining Xevant, Jeff successfully applied his extensive, multidisciplinary expertise in building and scaling growth and service infrastructures within start-up, mid-market, and Fortune 500 technology and services companies. He has recruited and built new leadership and functional teams within operations, sales, marketing, product development, client success, finance, and HR. The success of these business transformations also contributed to a culture of increased accountability and empowerment, contributing to significant improvement in employee engagement and overall enhanced business performance. Jeff holds an MBA from Duke University’s Fuqua School of Business in North Carolina and a Bachelor’s Degree in Finance and Economics from Grove City College in Pennsylvania.

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Lindsay Jones

Chief Financial Officer

Lindsay Jones, CPA, is a financial executive with experience in start-up companies & mature enterprises. He has a proven track record of helping, leading, and enhancing executive management teams. He has worked with private equity groups and private investors to identify, analyze, and close acquisitions and divestitures of companies. He has founded two startup companies, owned his own business, and closed over $500 million in private and public equity and debt financing, in his twenty-year career. 

Brandon Newman

Chief Executive Officer

Brandon has a dynamic, 25-year leadership career spearheading several businesses with emphasis on growth, revenue, and sales performance. He has run many high-growth environments, including start-ups, turnarounds, and $1B+ dollar businesses. As a serial entrepreneur, he has a proven record of founding new businesses and advancing them through growth and acquisition, merger, or roll-up including ScripPoint, Veridian, and AviaraMD. He is the driving force for vision, new market strategy, revenue growth, technology development, and partner alliances.