Advanced Knowledge and Skills of Originator and Biosimilar Biologics: For Health Care Providers from edX

- This course aims to provide advanced knowledge and skills for health care professionals on the topic of biosimilars, a class of biologic drugs or medical therapies that are highly similar to an existing originator medication that is off patent.

- Biosimilars present a rapidly growing area in pharmaceutical development, treatment options, and patient care that require an evidence-informed implementation approach.

- As awareness and use of biosimilars increases globally, this course will provide information and guidance to support the effective and safe use of biosimilars in clinical settings among health care providers.

- The course will focus on enhancing knowledge and skills to affect change in attitude and behaviour of health care providers related to biosimilars.

- The course will utilize a modular approach to provide content that is accessible and informative to all learners, including pharmacists, physicians, nurses, students and young professionals, industry, and policy-makers.

- This course may be eligible for continuing education credits through professional accreditation bodies.

- The course will also provide learners with opportunities to develop skills in each of these knowledge areas, with the overall aim of improving patient-provider communication and perceptions of biosimilar use and establishing a consistent foundation among health care providers for communicating with patients about biosimilar treatment.

- This course will build off of the material in BSS101 to provide advanced knowledge and skills related to use and implementation of biosimilar medications in clinical settings.

What you'll learn

Improve knowledge of originator biologic and biosimilar biologic medicines
Understand scientific and clinical evidence to support appropriate cost-effective application of biosimilars across oncology, rheumatology, gastrointestinal disease, and other medical conditions
Address misconceptions regarding use of biosimilars
Identify the benefits and significance of biosimilar use in clinical practice and across jurisdictions
Discuss implications of biosimilar use for clinical practice and patient education to optimize patient care and wellness

What's inside

Syllabus

Module 1 - Understanding Biologics and Biosimilars

Learning Objectives:

1. Describe biologic medications, including how they are manufactured and how they are used in clinical practice

2. Describe biosimilar biologics, how they differ from generics and how they are used in clinical practice

3. Define inherent variability and comparability.

4. Discuss the requirements and process for demonstrating comparability of biosimilar biologics

5. Describe why biosimilar medications are important now

Module 2 - Regulatory Approval Process

Learning Objectives: 1. Describe the approval process for biosimilars in Canada, including general considerations for new drugs and special considerations for biologics

2. Compare and contrast the approval process for biosimilar biologics and originator biologics

3. Examine the safety and efficacy of biosimilars

4. Describe pharmacovigilience and adverse reporting mechanisms for originator and biosimilar biologics in Canada

5. Describe the authorization of specific indications for biosimilars

6. Distinguish interchangeability and switching in relation to biosimilars

Module 3 - Instilling confidence in patients about their care plan & ethical considerations

1. Develop an awareness of ethics and ethical principles

2. Appreciate the ethical issues related to biosimilar biologics

3. Understand the factors that contribute to a trustworthy clinician-patient therapeutic relationship

4. Identify the communication skills needed to cultivate a trusting clinician-patient relationship, including with patients from diverse communities

5. Consider the broader structural influences on therapeutic trust within the context of biosimilar biologics

Module 4 - Discussing Biosimilars with your Patients

Learning Objectives: 1. Understand how patient expectations and beliefs impact treatment changes

2. Describe strategies to elicit patient perspectives on switching medications

3. Apply proven principles of patient-physician communication and motivational interviewing to discussions about switching medications

4. Identify strategies to create a positive mindset in patients for switching medications

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

Develops knowledge of biosimilar medications and strengthens existing foundation for health care professionals

Examines evidence-based approaches to implementing biosimilar medications

Teaches skills and knowledge relevant to the practice of health care professionals

Provides guidance that may support patient care and wellness

Builds a foundation for communicating with patients about biosimilar treatment

Uses a modular approach for content delivery

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in Advanced Knowledge and Skills of Originator and Biosimilar Biologics: For Health Care Providers with these activities:

Review basic pharmacology

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Prepare for success by refreshing your knowledge of basic pharmacology concepts

Browse courses on Pharmacology

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Review course content

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Reviewing concepts and definitions will assist you with the upcoming materials.

Browse courses on BioSimilars

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Review the course description and objectives.
Access modules 1-3 and skim the content.

Terminology Review Quiz

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This will help build your fluency with the key terms associated with biosimilars.

Browse courses on Definitions

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Define the term *biologic medication* compared to *biosimilar biologic*.
Explain *inherent variability* and its importance in relation to biosimilar medications.
Describe the process of demonstrating comparability between an originator biologic and a biosimilar biologic.

Four other activities

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Review the fundamentals of biosimilar medications

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By reviewing the basics of biosimilar medications, you can ensure that you have a solid understanding of the material covered in this course.

Browse courses on BioSimilars

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Read through the course syllabus and make note of any unfamiliar terms or concepts.
Review your notes from previous coursework in pharmacology or biology.
Watch online videos or read articles that provide an overview of biosimilars.

Complete the online tutorial on biosimilar interchangeability

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This tutorial will provide you with a deeper understanding of the interchangeability of biosimilars, which is an important concept in the field of biosimilar medications.

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Access the online tutorial on biosimilar interchangeability.
Follow the instructions in the tutorial and complete all of the exercises.

Participate in a discussion forum on the ethical considerations of biosimilar use

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Engaging in discussions with peers will allow you to explore different perspectives on the ethical considerations of biosimilar use and gain valuable insights.

Browse courses on Ethics

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Find a discussion forum or online group that focuses on biosimilars.
Post a question or comment to initiate a discussion on the ethical considerations of biosimilar use.
Actively participate in the discussion by responding to others' posts and sharing your own thoughts.

Develop a patient education handout on biosimilar medications

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Creating a patient education handout will help you to synthesize your knowledge of biosimilar medications and develop effective communication skills.

Browse courses on BioSimilars

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Gather information about biosimilar medications from reliable sources.
Organize the information in a clear and concise manner, using language that is easy for patients to understand.
Design the handout using visually appealing elements.
Proofread the handout carefully before sharing it with patients.

Career center

Learners who complete Advanced Knowledge and Skills of Originator and Biosimilar Biologics: For Health Care Providers will develop knowledge and skills that may be useful to these careers:

Regulatory Affairs Specialist

Regulatory Affairs Specialists ensure that pharmaceutical products meet regulatory requirements and are safe for public use. An understanding of biologics and biosimilars is essential as these products are highly regulated. This course can help Regulatory Affairs Specialists to understand the complex regulatory landscape for biologics and biosimilars, and to ensure that their products meet all regulatory requirements.

See salaries and explore the career path for Regulatory Affairs Specialist

Biostatistician

Biostatisticians use statistical methods to analyze data in the field of healthcare. An understanding of biologics and biosimilars is essential for Biostatisticians who are working on clinical trials or other research projects involving these products. This course can help Biostatisticians to understand the unique challenges of analyzing data from clinical trials for biologics and biosimilars.

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Clinical Research Associate

Clinical Research Associates are responsible for managing clinical trials. An understanding of biologics and biosimilars is essential for these professionals as these products are often used in clinical trials. This course can help Clinical Research Associates to understand the unique challenges of conducting clinical trials for biologics and biosimilars and to ensure that these trials are conducted in accordance with regulatory requirements.

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Quality Assurance Specialist

Quality Assurance Specialists ensure that pharmaceutical products are manufactured and distributed in accordance with quality standards. An understanding of biologics and biosimilars is essential as these products require specialized manufacturing and handling procedures. This course can help Quality Assurance Specialists to understand the unique quality requirements for biologics and biosimilars, and to ensure that these products meet the highest quality standards.

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Medical Science Liaison

Medical Science Liaisons are responsible for providing scientific information and support to healthcare professionals. An understanding of biologics and biosimilars is essential for these professionals, as they must be able to answer questions from healthcare providers about these products. This course can help Medical Science Liaisons to better understand key differences between biologics and biosimilars, along with their appropriate clinical use, which will enhance their ability to provide accurate and up-to-date information to healthcare providers.

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Medical Doctor

A Medical Doctor, or Physician, is responsible for treating patients with various health conditions and diseases. They may specialize in a particular field or work in general practice. An understanding of biologics and biosimilars is essential for their work as medications are often part of a treatment plan. This course can help Physicians to understand key differences between biologics and biosimilars, along with their appropriate clinical use.

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Pharmacist

Pharmacists are responsible for dispensing medications and offering advice to patients on the proper use of medications. In their role, it is important for Pharmacists to understand the differences between biologics and biosimilars and their safe and effective uses. This course can assist Pharmacists in better understanding key differences between biologics and biosimilars, along with their appropriate clinical use, which can positively impact the quality of the advice they provide to patients.

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Sales and Marketing Representative

Sales and Marketing Representatives for pharmaceutical companies are responsible for promoting and selling pharmaceutical products to doctors, hospitals, and other healthcare providers. An understanding of biologics and biosimilars is essential for these professionals as these products are often expensive and complex to manufacture. This course can help Sales and Marketing Representatives to better understand key differences between biologics and biosimilars, along with their appropriate clinical use, which can enable more effective promotion of these products.

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Nurse

Nurses provide a wide range of health care services, including administering medications and educating patients about their medications. A comprehensive understanding of biologics and biosimilars is not always required for Nurses, however, this course may be useful for Nurses who work in specialized areas or with patients who are taking biologics or biosimilars. It can help Nurses understand key differences between biologics and biosimilars, along with their appropriate clinical use, which can help to ensure patients receive the best possible care.

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Healthcare Consultant

Healthcare Consultants provide advice and support to healthcare organizations on a variety of topics related to healthcare. An understanding of biologics and biosimilars may not always be necessary for Healthcare Consultants but could enhance their ability to provide advice on areas such as product development, regulatory affairs, and market access. This course may be useful for Healthcare Consultants who want to expand their knowledge and expertise in the field of biologics and biosimilars.

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Policy Analyst

Policy Analysts develop and analyze policies for healthcare organizations. An understanding of biologics and biosimilars may not always be necessary for Policy Analysts, but is increasingly valuable as biologics and biosimilars are becoming more prevalent. This course may be useful for Policy Analysts who want to stay up-to-date on the latest developments in the field of biologics and biosimilars and to develop policies that will ensure that these products are used safely and effectively.

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Epidemiologist

Epidemiologists investigate the causes of disease and other health problems. An understanding of biologics and biosimilars is not always required for Epidemiologists but could be beneficial in areas such as studying the safety and effectiveness of new biologics and biosimilars.

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Healthcare Administrator

Healthcare Administrators plan, direct, and coordinate healthcare services. An understanding of biologics and biosimilars may not always be necessary for Healthcare Administrators, but is becoming more important as these products are becoming more prevalent in the healthcare system. This course may be useful for Healthcare Administrators who want to stay up-to-date on the latest developments in the field of biologics and biosimilars and to make informed decisions about the use of these products.

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Patient Advocate

Patient Advocates represent and support patients in the healthcare system. An understanding of biologics and biosimilars may not always be necessary for Patient Advocates, but could be beneficial in certain situations, such as when advocating for patients who are taking or considering taking biologics or biosimilars. This course may be useful for Patient Advocates who want to learn more about the benefits and risks of biologics and biosimilars and to be able to advocate for the best possible care for their patients.

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Medical Writer

Medical Writers create written content about medical topics for a variety of audiences. An understanding of biologics and biosimilars may not always be essential, but could be helpful for Medical Writers with a specialization in pharmaceuticals or healthcare policy. This course may be useful for Medical Writers who want to expand their knowledge and expertise in the field of biologics and biosimilars.

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Advanced Knowledge and Skills of Originator and Biosimilar Biologics

For Health Care Providers

What you'll learn

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What's inside

Syllabus

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Activities

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