Maintaining an influential role in the life sciences industry requires comprehensive knowledge of both biologics and biosimilars, along with their respective market share. Additionally, biosimilar job opportunities are expected to increase, granting aspiring life science professionals opportunities to join an expanding industry. Preparing for this evolving biologics and biosimilars segment of the industry requires establishing yourself as an expert and standing out among your peers. To meet a missing demand, ACMA (Accreditation Council for Medical Affairs) has developed a Board Certified Biologics and Biosimilars Specialist (BCBBS) program.

For life science organizations, upskilling an entire medical affairs team through a biologics and biosimilar education ensures the organization's members have the same level of knowledge and collaborate effectively. As a result of the demand for biosimilars and advances in R&D, the market for biosimilars will continue to accelerate. However, biosimilars face barriers, including provider hesitation and payer incentives for originator products. The Biologics and Biosimilars Specialist Program provides insight into these obstacles for biosimilars, among other topics.

The ACMA’s Biologics and Biosimilars Specialist Program includes the following topics: 

• Biologic Medicines: A History and Their Importance

• Biosimilars in the U.S. Today

• Economic Considerations With Biosimilars

• Regulatory and Scientific Concepts for Biologics

• Challenges for Biosimilars in the U.S. Market

• Clinical Guidelines and Real-World Evidence (RWE)

• Using and Navigating FDA Resources, including the Purple Book Database

• International Experience with Biosimilars

• The Future of Biosimilars

Understanding Biologics vs. Biosimilars

Biologics are medications containing biological products derived from living sources such as bacteria, yeast, and animal cells. Biosimilars are also medications containing biological products but biosimilars use are ference product (originator biologic) as a template to create the new biosimilar. Since biologics and biosimilars contain biological compounds, each batch has inherent variations. However, biosimilars are “highly similar” and clinically equivalent to their originator drug.

The following are types of biologics and biosimilars:

• Vaccines

• Stem cell therapies

• Steroid hormone therapies

• Antitoxins

• Blood or other blood products

• Gene therapies

• T-cell therapies

• Monoclonal antibodies

What's driving biosimilar market growth? 

Key factors driving the growth and approvals of biosimilars include:

• Demand: an aging population and an increase in chronic diseases.

• Patent expirations: numerous originator products' patents expire in the next five years. 

• Abbreviated approval pathway: allows licensing of biosimilars under 351(k) of the Public Health Service Act (PHS Act), which requires less clinical data.

• Commercial partnerships: cost-sharing 

• Education initiatives: Advancing Education on Biosimilars Act of 2021 promotes biosimilar education for healthcare providers (HCPs)

How has the biosimilar market evolved?

In 2010, the Biologics Price Competition and Innovation Act (BPCIA) granted 12 years of market exclusivity for biologics and established an abbreviated pathway to FDA approval for biosimilars under section 351(k).1 However, pharmaceutical companies have created “patent thickets”(overlapping patents), which blocked biosimilars' entry into the market. 

On March 6, 2015, Zarxio® (filgrastim-sndz) became the first biosimilar approved in the U.S.4 Many providers have recently been faced with prescribing biosimilars for the first time, leading to uncertainty and increasing demand for biosimilar education aimed at providers. 

The blockbuster drug, Humira® (adalimumab), is at the center of multiple patent lawsuits. In 2021, Humira® ranked second in U.S. sales with $20.7 billion. Humira® launched in 2003 and, over the years, has expanded its indication from rheumatoid arthritis to include other diseases such as psoriasis, Crohn's disease, and ulcerative colitis.3 Abbvie, the manufacturer of Humira®, recently won an antitrust case in August 2022, with the judge citing that the 132 patents Abbvie created were not unlawful. 

Another milestone for Humira® is the United States Food and Drug Administration's (FDA) approval of Cyltezo (adalimumab biosimilar), the first interchangeable biosimilar to Humira®, in October of 2021. The interchangeable designation requires additional paperwork and studies for regulatory approval, but this status allows pharmacists to make substitutions between the originator biologic and the biosimilar without approval from the prescriber. The interchangeable biosimilar designation remains confusing for many prescribers, patients, and pharmacists.

So far, the FDA has approved only three biosimilars as interchangeable. To qualify as an interchangeable biosimilar, trial sponsors must meet additional requirements, including switching studies, demonstrating patients can switch between the reference product and biosimilar without experiencing side effects or loss of efficacy.

In early August 2022,Coherus BioSciences received approval for Cimerli (ranibizumab-eqrn), a biosimilar to Roche's Lucentis, for the treatment of wet age-related macular degeneration. As well as being the second biosimilar approved by the FDA for Lucentis, Cimerli is the first interchangeable biosimilar for any indication approved without a switching study. With this approval, other biosimilar developers may be able to reduce the time to market, potentially improving the speed of biosimilar adoption.

Which organizations are driving the development of biosimilars?

The leading life science organizations developing biosimilars include:

• Novartis

• Pfizer

• Amgen

• Biogen

• Samsung Bioepis

Biosimilar development is driven primarily by smaller companies, while large companies execute marketing. Globally, Novartis is leading the way in available jobs (406) and Amgen led the way in biosimilar filings (see figure below).

Biosimilar Resources

• Learn more about the ACMA’s Board Certified Biologics and Biosimilars Specialist Program (BCBBS®)

• Read Biologics and Biosimilars 101 

• Understand the biosimilars pipeline: Cardinal Health Biosimilar Pipeline Update

• State Regulations for Biosimilar Interchangeability 

• Read Iqvia Institute's Biosimilars in the United States 2020–2024.

References

1. Cardinal Health. 2022 Biosimilars Report: The U.S. Journey and Path Ahead.; 2022.https://www.cardinalhealth.com/content/dam/corp/web/documents/Report/cardinal-health-2022-biosimilars-report.pdf

2. Declerck P, Danesi R, Petersel D, Jacobs I. The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects. Drugs. 2017;77(6):671-677. doi:10.1007/s40265-017-0717-1.

3. Ellis CR, Azmat CE. Adalimumab. [Updated 2022 Jan 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from:https://www.ncbi.nlm.nih.gov/books/NBK557889/

4. Raedler LA.Zarxio (Filgrastim-sndz): First Biosimilar Approved in the United States. Am Health Drug Benefits. 2016;9(Spec Feature):150-154.