Addressing the Knowledge Gap in Biologics & Biosimilars: Is a Board Certified Biologics and Biosimilars Program the Answer?

The Accreditation Council for Medical Affairs (ACMA) will launch the Board-Certified Biologics and Biosimilars Specialist Program (BCBBS), the first accredited program specializing in biologics and biosimilars, in December 2022.

According to the IQVIA Institute for Human Data Science, biologics, medications derived from living organisms, have emerged as one of the fastest growing markets.⁴ In the United States, biologics account for 43% of all drug spending.³ Increasing demand for vaccines and targeted therapies, along with advances in drug development through artificial intelligence, are driving growth in the global biologics industry.

As the biologics market rapidly expands, professionals will need skills aligned with market demands to ensure the adoption of biologics and biosimilars. The adoption of biosimilars plays a critical role in reducing the overall cost of drug prices, especially in the United States. Biosimilars are "highly similar" to originator biologics yet are typically 30% less expensive.³ The BCBBS program offered by the ACMA will enable healthcare and life sciences professionals to gain insight into biologics and biosimilars beyond clinical guidelines. Understanding the regulatory, reimbursement, and economic implications of biologics enhances life science professionals' ability to navigate a rapidly evolving market.BCBBS will also provide 10 continuing education (CE/CME) credits to U.S licensed physicians and pharmacists.

The ACMA and the U.S. Food and Drug Administration (FDA) recognize the importance of preparing life sciences professionals for the expanding biologics market through education. The ACMA created the BCBBS program to educate all life sciences professionals (e.g., pharmacists, prescribers, PhDs, Industry/MSLs, etc.). The BCBBS program ensures life sciences professionals can navigate the complex regulatory and reimbursement landscape of biologics, establishes experts for healthcare provider (HCP) education, and sets industry standards for managing biologics and biosimilars.

Aligning Skills Training With Market Trends

Regulatory and reimbursement landscapes have become complex as the biologics market has evolved. The BCBBS program provides practical skills to overcome reimbursement obstacles and ensure patients can access affordable medications. During the program, participants learn how to choose life-saving therapies strategically for patients, navigate Medicare Part B and Medicare Part D reimbursement processes, determine eligibility for pass-through status, and evaluate the cost-effectiveness of comparable therapies.

As the biologics market has grown in recent years, medical affairs teams have become increasingly involved in optimizing patient access and communicating the value of new therapies, including biologics and biosimilars, to HCPs and other stakeholders.¹ Optimizing patient outcomes requires a team of knowledgeable, highly skilled professionals who can facilitate biologics development, commercialization, and communication. Creating effective medical affairs teams for the future starts with cultivating the essential knowledge and skills to adapt to evolving biologics industry trends. The BCBBS program offers the education required to empower medical affairs teams and enable them to succeed.

Establishing Experts to Enhance Provider Education

Medical affairs will increasingly play a vital role in educating HCPs about biosimilars, including their potential to reduce prescription drug costs and enhance health equity. According to IQVIA’s Biosimilars in the United States 2020–2024 report, biosimilars have the potential to reduce prescription drug costs by $100 billion over the next five years.³ However, biosimilar adoption faces many barriers, including provider hesitation.⁵

While biosimilars can improve patient care, a lack of provider education is a significant obstacle.⁵ The FDA approved the first biosimilar in 2015, making biosimilars a relatively new class of drugs. When new therapies are introduced, providers often question their safety and efficacy.²

Developing medical affairs teams capable of communicating biosimilars' value to HCPs and other stakeholders is essential to improving biosimilar adoption. The United States passed the Advancing Education on Biosimilars Act in April 2021 in recognition of the need to educate HCPs about biosimilars. The law requires the FDA to maintain an educational website for HCPs and patients to increase awareness of biosimilars' benefits.

With biologics expanding into new therapeutic areas, many specialists are prescribing biologics for the first time creating demand for effective HCP education.² The Pharmaceutical Research and Manufacturers of America (PhRMA) trade group also acknowledges the need for additional biosimilar education and experts. According to the group, “we need to encourage continued focus on increasing provider and patient education to maximize the benefits…this effort should include the development and dissemination of evidence-based materials on the full range of treatment options, including biosimilars, to further support appropriate biosimilar adoption.” The BCBBS program provides this education and establishes experts in biosimilars to enhance their adoption.

Setting Industry Standards

Since 2015, the ACMA has been setting industry standards for the life sciences industry. Over the years, the ACMA has educated and trained thousands of life science professionals. Along with education, students receive mentorship and earn continuing education hours when completing certifications. The ACMA recognizes the importance of biologics education in preparing future industry leaders.

According to William Soliman, Ph.D., BCMAS, ACMA Founder and CEO, “the ACMA believes that establishing a standard of excellence for the biologics and biosimilars arena will be key as the life sciences industry navigates several obstacles regarding the adoption of biosimilars such as clinical confidence and patient insurance and prior authorization issues.”

The BCBBS program enables professionals to develop skills for the future through a practical case-based approach, expert-developed content, and a flexible learning environment. To learn more about ACMA’s BCBBS program, visit the following resources.

Learn more about the ACMA's Board Certified Biologics and Biosimilars Specialist Program here. Register for an upcoming webinar on the topic of Biologics & Biosimilars Interchangeability, here.

References:

1. Bedenkov A, Rajadhyaksha V, Beekman M, et al. Developing medical affairs leaders who create the future. Pharmaceut Med. 2020;34(5):301-307. doi:10.1007/s40290-020-00351-y
2. Cardinal Health. 2022 Cardinal Health Biosimilars Report: The U.S. Journey and Path Ahead.; 2022.https://www.cardinalhealth.com/en/product-solutions/pharmaceutical-products/biosimilars/biosimilars-report.html
3. IQVIA Institute for Human Data Science. Biosimilars in the United States 2020–2024. 2020. https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024
4. IQVIA Institute for Human Data Science. Disruption and maturity: The next phase of biologics. 2017. https://www.iqvia.com/-/media/iqvia/pdfs/nemea/uk/disruption_and_maturity_the_next_phase_of_biologics.pdf
5. Oskouei ST, Kusmierczyk AR. Biosimilar Uptake: The Importance of Healthcare Provider Education. Pharmaceut Med. 2021;35(4):215-224. doi:10.1007/s40290-021-00396-7