The Future of Biosimilars: What To Expect Next

Doctor taking pain and stress relief medicine to help with mental health during cover fatigue. Medical healthcare professional nurse showing the correct drug dose by pouring the pills in her hands

To discern the future of biosimilars, a look at how far innovation in biologics has come is helpful. Biologics have saved millions of lives over the years and raised the standards of living for tens of millions more. But modern pharmaceutical markets also bring complex challenges to healthcare.

We will take a close look at the past, present, and future of biosimilars, including market challenges and the great potential they can provide humanity.

About Biologics

Biologics are pharmaceutical products designed to treat diseases and offer therapeutic solutions. Unlike chemically derived drugs, they are derived from living organisms like stem cells, animal tissues, bacteria, and numerous other sources. Biologics include gene therapies, monoclonal antibodies, blood products, and a host of other therapeutics.

What Are Biosimilars?

As the name suggests, biosimilars are drugs designed to work the same as a biologic. Biosimilars do not contain any significant safety, quality, or effectiveness variance from FDA-approved biologics. Biosimilars are typically brought to market when the patent for a biologic has expired.

The first biologics date back more than one hundred years and led to medical breakthroughs like the smallpox vaccine. But biosimilars are a much more recent discovery.

The Biologics Price Competition and Innovation Act of 2009 provided a clear pathway for biologics to receive FDA approvals, which helped to incentivize innovation and development while protecting patents at the same time. As a result, biosimilars can provide alternatives to innovator biologics.

The first globally approved biosimilar was introduced in the EU in 2013. The US Food and Drug Administration (FDA) approved the first biosimilar in the US two years later, in 2015.

What Is the Potential of Biosimilars?

Biosimilars can bring diverse options to the market with the intent of giving patients more affordable alternatives to name-brand prescriptions.

For example, Humira is FDA-approved for treating rheumatoid arthritis and Crohn’s disease. It is one of the most expensive drugs ever prescribed, with a monthly cost averaging $9,065.

There are 10 biosimilars heading to market in 2023 that aim to offer comparable results at a dramatically reduced price.

What Are Contributing Factors to Biosimilar Market Growth?

Biosimilars are expected to become an increasingly significant factor in the overall growth of biologics. In fact, the global biologics market is expected to double to $712.45 billion by 2032, and biosimilars alone have seen a 56 percent compound annual growth from 2015 to 2020.

There is a rise in sentiment for intermediaries advocating for responsibility and transparency regarding how reimbursements, rebates, and other costs are managed with name-brand pharmaceuticals.

Positive Support from Legislation

The Inflation Reduction Act (IRA) includes an amendment to the non-interference clause which requires HHS to negotiate prices with drug companies that make specific brands, aiming to reduce costs under Medicare Part D.

The IRA seeks to encourage biosimilar developments by boosting reimbursements to physicians and supporting lower list prices, with the ultimate goal of making biosimilars more widely available at competitive prices.

The IRA will likely steer market growth with policies surrounding biosimilar adoption, including:

  • Promoting their interchangeability with name brands
  • Advocating for better transparency
  • Expanding Medicare Part D coverage
  • Including biosimilars in the structure of formularies and reimbursements
  • Tracking intermediary pricing and rebates to reveal market value

In addition to the IRA, multiple US states have introduced legislation promoting biosimilar adoption, with the intent of categorizing them similarly to generic drugs.

What Is the Future of Biosimilars?

Expectations are high as legislators, physicians, and pharmacists align to better market options.

There are different projections for biosimilar market growth, but they all trend positively. The availability of lower-cost biosimilars has saved US healthcare more than $12.6 billion since 2011.

According to the National Center for Biotechnology Information, cost savings of biosimilars could amount to $54 billion from 2017-2026, while others place those savings anywhere from $85 to $133 billion by 2025.

We should expect to see the following in US markets:

  • Rapid changes based on market evidence and research
  • Expanded pharmacy reimbursement
  • More biosimilar therapeutic options
  • Faster approvals for biosimilar interchangeables
  • Emphasis on education and data-driven evidence

Why Are Biosimilars the Future of Healthcare?

The following are indicators of a strong, continued uptake in biosimilars in US healthcare markets.

Growing Markets

Biosimilars will grow in market share as expiring patents and political incentives allow more manufacturers to enter the market with alternatives.

Expanding Therapeutic Biosimilars

Biosimilars for diabetes, ophthalmology, and immunology will likely expand, and if formularies and evolving reimbursement plans lead to greater patient savings, as hoped, this will increase political optimism, bolstering easier approvals.

Supporting Technological Advancements

Improved manufacturing processes, technology like artificial intelligence (AI) and machine learning, and clear guidelines for product approvals will rapidly scale new medical innovations.

Increasing Savings

Changing dynamics in market competition and greater potential for interchangeability will help reduce costs and offer more affordable options for patients.

Broadening Healthcare Coverage

The US government is showing clear support for biosimilars by calling for a boost in Medicare coverage, where plans pay for a biosimilar’s price plus 8 percent.

Comparing the US to Early Trends in European Markets

Looking at promising early signs in European healthcare markets suggests the following policy recommendations will move US markets in the right direction:

  • Incentivizing innovation
  • Letting physicians choose which medicines to prescribe
  • Supporting intellectual property
  • Avoiding forced-switching
  • Looking to clinical trials for guidance
  • Seeking post-market surveillance to keep pricing and third parties honest and accountable

In addition, the Center for Medicare & Medicaid Innovation (CMMI) is expected to push for coverage under Medicare Part D.

Potential Roadblocks: What Is the Problem with Biosimilars?

The potential for market growth looks hopeful for biosimilars, but the following potential roadblocks have to be considered at this crucial point in time.

Competition from Innovators

The brands currently dominating markets with their patented innovations may launch their own biosimilars to go head-to-head with competitors.

Regulatory Challenges

There are concerns that political overzealousness stemming from the Inflation Reduction Act in the biosimilar marketplace could stifle patented innovations, along with fears over unintentional price-setting. For instance, the IRA provides for delaying negotiations regarding biologics that are likely to see competition from biosimilars within two years of publication. While this is meant to deter financial incentives that could slow biosimilar uptake, it could also unintentionally stall innovation and funding for important innovations.

However, the IRA also amends the non-interference clause by adding an exception that requires the Secretary of HHS to negotiate prices with innovator drug companies for a small number of their patented biologics that don’t have a biosimilar competitor covered under Medicare Part D. It is possible that negotiating better prices for unchallenged innovator products can lead to a positive outcome.

Concerns Over Patent Protection

Market originators often have to fight legal battles to protect their inventions. In the case of biosimilars, this can delay products coming to market and leave a cloud of uncertainty for investors and other stakeholders.

Lack of Education

Physicians, legislators, and patients need to become familiar with the effectiveness and safety standards of biosimilars in order for uptake to trend positively.

To overcome these roadblocks, healthcare stakeholders and regulators will have to extend efforts to support research and development, provide clarity for future patent protection, and increase public awareness of the benefits of biosimilars.

The Future of Biosimilars Will Be Determined by Data

Expectations are high for biosimilars. But one thing is clear—legislators, physicians, and patients alike are looking to data from market experts to show the potential of cost savings, market diversity, and interchangeability.

PBMs are essential to data clarity, and Xevant provides these crucial intermediaries with the deep analytics they need.

Our PBM software helps you:

  • Reduce costs
  • Improve data analytics
  • Uncover issues with benefits
  • Gain better market insight

Learn how Xevant can help you with market insights, client metrics, rebate management, and more.

Try Xevant's Analytics Platform for Free
views

Try Xevant for Free

Sign Up for Blog Updates

Name
This field is for validation purposes and should be left unchanged.

Search Blog

Xevant

Xevant logo with stylized X.

Blog Sign up

Subscribe to our blog and receive the latest Xevant news and updates.

Name
This field is for validation purposes and should be left unchanged.

Mitch Searle

Director, Growth Marketing

Mitchell is a seasoned marketing leader with over a decade of experience driving direct-response demand. From bootstrap budgets to multi-million dollar per month budgets, Mitchell knows how to ensure positive returns on marketing investments. With extensive experience in both B2C and B2B, he has a knack for delivering show-stopping and world-class campaigns that generate immediate impact as well as long-lasting impressions.

Dave Sanders headshot (640x462)

Dave Sanders

VP, Data

With almost 20 years of experience as a senior executive and strategic leader in the data industry, Dave transforms companies through innovative technology solutions. He’s built high performing teams at various types of companies, including Ancestry, the New England Patriots, and Vivint. Dave has successfully migrated many companies to the cloud and always enjoys the challenge of improving processes. He’s excited to help lead Xevant data engineering to make an impact in healthcare.
David Ninow headshot (640x462)

David Ninow

VP, Product Management

Serving as Xevant’s VP of Product Management, David is a product and technology executive who has led and scaled successful product teams at organizations ranging from high-growth startups to established multi-billion-dollar B2B brands. With expertise building innovative SaaS solutions that disrupt established markets, he is laser-focused on driving the realization of Xevant’s industry-changing vision with world-class product strategy and execution. David is an avid outdoorsman, musician, and family man; perfectly positioned at the foot of the beautiful Wasatch Mountains in Utah.

2024 DRUG PRICE INFLATION

How real-time insight into rising drug prices can lead to lower costs and better health outcomes.
Pete Tantillo

Pete Tantillo

Chief Financial Officer

Pete is an accomplished technology executive who has led many organizations through high growth and profitability stages and has worked with some of the world’s largest companies. Pete most recently completed an exit for RapidRatings, a highly successful data and information analytics company in the risk management and supply chain analytics space where he was both CFO and COO for the business. Prior to RapidRatings, Pete spent ten years working for private-equity and venture backed technology companies in both SaaS and traditional software solutions. Pete also spent 13 years at powerhouse technology company SAP where he led field services for SAP America. Pete started his career in public accounting with Arthur Andersen & Co and is a licensed CPA. He graduated with a business degree from the College of William & Mary in Virginia. 

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.

Todd Rode

VP, Corporate 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.

Megan Foster headshot

Megan Foster

Manager, People Operations

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.

Greg Abram headshot

Greg Abram

Chief Growth Officer

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 headshot

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.
Marvin Roi Elvambuena headshot

Marvin Roi Elvambuena

Director, Web Development

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.

Jeff Weber headshot

Jeff Weber

Chief Operating 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.
Griff McGee headshot

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.

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.

Gerrit Lemmen headshot

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 headshot

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 headshot

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.

Headshot of Jace Garfield, the Chief Technology Officer.

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 headshot

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.

Headshot of Lindsay Jones, the Chief Financial Officer.

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.