Foundations of Originator and Biosimilar Biologics: for Patients and Caregivers from edX

- This course aims to provide knowledge and skills for patients 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 represent 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 patient understanding of the effective and safe use of biosimilars in clinical settings.

- The course will focus on enhancing knowledge and skills for patients and caregivers related to biosimilars.

- The course will utilize a modular approach to provide content that is accessible and informative to all learners, and provide an introduction to biosimilar medications including what they are, regulatory processes, access, and discussing biosimilars with your healthcare provider.

What you'll learn

Improve knowledge of biologic and biosimilar medicines
Understand the evidence for the most appropriate and cost-effective use of biosimilars for different medical conditions
Address misconceptions regarding use of biosimilars
Identify the benefits and use of biosimilars in clinical practice across provinces and territories in Canada

What's inside

Syllabus

Module 1 - Understanding Biologics and Biosimilars

Learning Objectives: 1. Describe biologic medications, including how they are made and how they are used in clinical practice

2. Describe biosimilar biologics, including how they differ from other generic medications and why they are used in clinical practice

3.Compare and contrast biologic and biosimilar medications

Module 2 - Regulatory Approval Process

Learning Objectives: 1. Describe Health Canada's approval process for biosimilar biologic use and sale in Canada

2. Describe the safety and monitoring activities of biosimilar biologics, including the similarities between originator and biosimilar biologics

3. Explain the purpose of and the steps to find a product monograph on biosimilars

4. Describe the indications for originator and biosimilar biologics

5. Distinguish between interchangeability and switching between originator and biosimilar biologics.

Module 3 - Patient Access

Learning Objectives: 1. Understand the significance and use of biosimilars in certain people livin with diseases

2. Describe how biosimilar biologics are paid for in Canada

3. Describe Patient Support Programs (PSPs) and their role in helping patients coordinate cost and administration of biosiilar biologics

4. Describe the administration of biologics and possible changes when a patient is switched to a biosimilar

Module 4 - Discussing Biosimilars with your Health care Provider

Learning Objectives: 1. Explain how biosimilar use is monitored in Canada with respect to side effects and adverse drug reactions

2. Describe common facts about biosimilar biologics to become more familiar with them

3. Gain confidence in talking to your healthcare provider and others about biosimilar biologics

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

Explores biosimilars, which is standard in healthcare

Taught by Kathy Vu, who are recognized for their work in biosimilars

Develops knowledge and skills for patients and caregivers on biosimilars

Provides information and guidance to support patient understanding

Examines evidence-informed implementation approach

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 Foundations of Originator and Biosimilar Biologics: for Patients and Caregivers with these activities:

Review fundamentals of pharmacology

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This refresher will enhance your understanding of the course material by reviewing concepts from pharmacology.

Browse courses on Pharmacology

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Review your notes or a textbook on basic pharmacology principles.
Complete practice problems or quizzes to test your understanding.

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Career center

Learners who complete Foundations of Originator and Biosimilar Biologics: for Patients and Caregivers will develop knowledge and skills that may be useful to these careers:

Medical Science Liaison

Medical Science Liaisons (MSLs) serve as a critical bridge between pharmaceutical companies and healthcare providers. They provide scientific and medical expertise to healthcare professionals, and they play a key role in the development and implementation of new treatments. This course on biosimilars can help MSLs stay up-to-date on the latest developments in this rapidly growing field. It can also help them develop the skills and knowledge they need to effectively communicate with healthcare providers about biosimilars.

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Regulatory Affairs Specialist

Regulatory Affairs Specialists ensure that pharmaceutical products meet all regulatory requirements. They work with government agencies to ensure that products are safe and effective, and they develop and implement strategies to comply with regulatory requirements. This course on biosimilars can help Regulatory Affairs Specialists stay up-to-date on the latest regulatory developments in this field. It can also help them develop the skills and knowledge they need to effectively navigate the regulatory process.

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Clinical Research Associate

Clinical Research Associates (CRAs) manage clinical trials, ensuring that they are conducted safely and ethically. They work with investigators, study coordinators, and other members of the research team to ensure that the trial is conducted according to protocol. This course on biosimilars can help CRAs develop the skills and knowledge they need to effectively manage clinical trials involving biosimilars.

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Pharmacist

Pharmacists dispense medications, provide patient counseling, and manage drug therapy. They play a key role in ensuring that patients receive the right medication at the right dose and at the right time. This course on biosimilars can help Pharmacists stay up-to-date on the latest developments in this field. It can also help them develop the skills and knowledge they need to effectively counsel patients about biosimilars.

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Nurse

Nurses provide patient care, including administering medications, monitoring patients, and providing emotional support. They play a key role in ensuring that patients receive the best possible care. This course on biosimilars can help Nurses develop the skills and knowledge they need to effectively care for patients who are taking biosimilars.

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Patient Advocate

Patient Advocates represent the interests of patients in the healthcare system. They work to ensure that patients have access to quality care, and they provide support and guidance to patients and their families. This course on biosimilars can help Patient Advocates stay up-to-date on the latest developments in this field. It can also help them develop the skills and knowledge they need to effectively advocate for patients who are taking biosimilars.

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Medical Writer

Medical Writers create and edit medical content, including scientific papers, clinical trial reports, and patient education materials. They play a key role in communicating medical information to a variety of audiences. This course on biosimilars can help Medical Writers stay up-to-date on the latest developments in this field. It can also help them develop the skills and knowledge they need to effectively write about biosimilars.

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Healthcare Consultant

Healthcare Consultants provide advice and guidance to healthcare organizations on a variety of topics, including biosimilars. They help healthcare organizations develop and implement strategies to improve patient care, reduce costs, and improve efficiency. This course on biosimilars can help Healthcare Consultants stay up-to-date on the latest developments in this field. It can also help them develop the skills and knowledge they need to effectively advise healthcare organizations on biosimilars.

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Biostatistician

Biostatisticians design and analyze statistical studies in the field of medicine. They play a key role in developing and evaluating new treatments, and they help to ensure that clinical trials are conducted safely and ethically. This course on biosimilars can help Biostatisticians stay up-to-date on the latest developments in this field. It can also help them develop the skills and knowledge they need to effectively design and analyze clinical trials involving biosimilars.

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Epidemiologist

Epidemiologists investigate the causes and distribution of diseases in populations. They play a key role in developing and implementing public health policies, and they help to protect the public from disease outbreaks. This course on biosimilars may help Epidemiologists stay up-to-date on the latest developments in this field. It may also help them develop the skills and knowledge they need to effectively investigate the causes and distribution of diseases related to biosimilars.

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Healthcare Administrator

Healthcare Administrators oversee the day-to-day operations of healthcare organizations, including hospitals, clinics, and nursing homes. They play a key role in ensuring that patients receive quality care, and they work to improve the efficiency and effectiveness of healthcare organizations. This course on biosimilars may help Healthcare Administrators stay up-to-date on the latest developments in this field. It may also help them develop the skills and knowledge they need to effectively manage healthcare organizations that use biosimilars.

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Physician Assistant

Physician Assistants (PAs) provide patient care under the supervision of a physician. They perform a variety of tasks, including taking medical histories, performing physical exams, and prescribing medications. This course on biosimilars may help PAs stay up-to-date on the latest developments in this field. It may also help them develop the skills and knowledge they need to effectively care for patients who are taking biosimilars.

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Registered Nurse

Registered Nurses (RNs) provide patient care, including administering medications, monitoring patients, and providing emotional support. They play a key role in ensuring that patients receive the best possible care. This course on biosimilars may help RNs stay up-to-date on the latest developments in this field. It may also help them develop the skills and knowledge they need to effectively care for patients who are taking biosimilars.

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Medical Technologist

Medical Technologists perform laboratory tests on patient samples to help diagnose and treat diseases. They play a key role in ensuring that patients receive the correct diagnosis and treatment. This course on biosimilars may help Medical Technologists stay up-to-date on the latest developments in this field. It may also help them develop the skills and knowledge they need to effectively perform laboratory tests on patient samples involving biosimilars.

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Pharmaceutical Sales Representative

Pharmaceutical Sales Representatives (PSRs) sell pharmaceutical products to healthcare providers. They play a key role in educating healthcare providers about new drugs and treatments, and they help to ensure that patients have access to the medications they need. This course on biosimilars may help PSRs stay up-to-date on the latest developments in this field. It may also help them develop the skills and knowledge they need to effectively sell biosimilars to healthcare providers.

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