ACMA Begins Board Certification Program for Biologics, Biosimilars Specialists

The Accreditation Council for Medical Affairs (ACMA) is launching a new program for health care professionals to become Board Certified Biologics and Biosimilars Specialists (BCBBS).

“The [BCBBS program] is a self-paced, online, board certification program that strives to set the standard of excellence in the field of biologics and biosimilars. [Its mission is] to establish expertise among professionals involved in the optimization of biological therapy. The BCBBS enhances your understanding of the regulatory and analytical landscape of biologics and biosimilars allowing you to power your career in a rapidly expanding field,” ACMA described on the program’s official website.

ACMA said that the program takes 40 hours to complete and will provide 24/7 live chat support. Health care professionals who take the course can obtain continuing medical education or continuing education credits. Interested parties can register now and registration can be completed at any time throughout the year.

Along with the FDA’s curriculum toolkit, ACMA’s BCBBS program is the first and only recognized US and International Board Certification Program for health care professionals and researchers in order “to create an internationally-accepted standard of knowledge, education, and experience” regarding biologic and biosimilar drugs.

ACMA said that it developed the program to evaluate the knowledge base and application of best practices for treating patients who need therapy with biologics or biosimilars as well as those who work in the pharmaceutical, biotechnology, medical devices, or diagnostic industries, allowing them to gain a deeper understanding of reference biologics and biosimilars.

The program includes 9 learning modules and participants are given 6 months to complete the program. The modules cover a variety of topics including, the history of biologics, the current status of and barriers to using biosimilars in the United States, navigating FDA resources and the Purple Book, the future of these medicines, regulatory and economic considerations, clinical guidelines and real-world evidence, and the international experience with biosimilars.

Also, the program contains an exam and participants will be given 100 practice questions. Each module includes an optional quiz prior to starting the module and a quiz for after (post-quizzes). Participants will have 5 chances to pass post-quizzes and 4 opportunities to pass the board exam.

ACMA claimed that the program will reduce hesitancy around interchangeable biosimilars. There are currently 4 biosimilars with an interchangeability designation, with more expected to be approved for the designation on the horizon. These biosimilars have been approved using different criteria and 1 is not offered at the pharmacy level, causing a lot of confusion in the biosimilar industry about the safety and relevance of interchangeability designations.

Additionally, several states and Puerto Rico have laws restricting interchangeability and some pharmacy benefit managers and payers have prior authorization policies, which can cause concerns about how useful interchangeability designations will be in increasing access to biosimilars. Legislation on changing requirements for obtaining interchangeability designations has been proposed to Congress, which could impact patient and provider comfortability with interchangeable biosimilars.

In order to be eligible for certification for any of ACMA’s programs, participants must have completed at least a bachelor’s degree and have 2 years of relevant professional experience, such as experience working in the pharmaceutical industry or clinical/research experience, or hold at least one of the following degrees from an accredited college, university or institution:

• MD
• PharmD
• PhD
• DO
• MBBS
• DNP
• NP
• PA
• BPharm
• PsyD
• Other relevant degree

In total, the program will cost registrants $1999. The application fee is $49 and the entire course costs $1000. The examination fee amounts to $800 and the credentialing fee costs $150. AMCA allows registrants to pay once for the whole course, to pay in 3 monthly installments of $716.33, or to pay through a PayPal CREDIT Financing plan. Participants who find that they cannot complete the course in 6 months can pay an extension fee of $399 regardless of how long the extension is needed.