Welcome to the Biosimilars Medical Academy, an educational platform designed by medical professionals to provide high quality medical education. The Academy brings you exclusive content in rheumatology, gastroenterology, dermatology and immunology through engaging content.

This website is developed and funded by Biogen.

Welcome

BMA

Here’s what’s new

Understanding biosimilars – new biosimilars animations

From development to bench-side, these animations explain key supporting elements for the use of biosimilars

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educational-modules educational-module-psoriasis

Educational modules on inflammatory diseases

Take this interactive courses to learn about the essential facts of rheumatoid arthritis, psoriasis and inflammatory bowel disease - from pathophysiology to diagnosis and treatment.

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Further information on biosimilars

Increasing number of biosimilars

11/11/2021

The number of biosimilars is increasing especially within three therapeutic areas. Find out more.

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11/11/2021

The basics of biosimilars

As most originator biologic medicines are complex molecular entities, so are biosimilars. Get to understand the complexity of biosimilars.

11/11/2021

Totality of evidence

What does it take to get a biosimilar approved? Learn more about the evidence needed to establish biosimilarity.

11/11/2021

Regulations

Discover what the regulatory process for biosimilars looks like. How does it differ from reference biologics?

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Unmet need and limited access

Patient access to biologics is varied and often linked to affordability creating an unmet need.

Immune-mediated inflammatory diseases (IMID) are progressive disorders, requiring timely and continuous treatment. Current guidelines often reserve these treatments for patients with more severe disease and/or patients who have failed to respond to multiple other treatments. In some countries, access to biologics may then be further limited by the implementation of national eligibility and reimbursement criteria. This creates an unmet need in many countries worldwide, leaving a gap for biosimilars to fill.

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Video resources

Do you want to learn about the concept of biosimilars? Then this video series is the right resource for you. 

Learn through a series of videos the essential facts about RA, Psoriasis and IBD.

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Featured publications

Category: Burden of Disease, Zabotti A, De Marco G, Gossec L, et al. Ann Rheum Dis 2023

EULAR points to consider for the definition of clinical and imaging features suspicious for progression from psoriasis to psoriatic arthritis.

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The multidisciplinary EULAR task force developed guidelines for the clinical management of psoriasis patients  (PsO) who are at risk to develop psoriatic arthritis (PsA) with focus on early diagnosis, the prevention and interception of PsA. 

Category: Biosimilars Development and evidence European Commission

Biosimilars in the EU: Information Guide for Healthcare Professionals

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Since the EU approved the first biosimilar medicine (‘biosimilar’) in 2006, the EU has pioneered the regulation of biosimilars. Over the past 10 years, the EU has approved the highest number of biosimilars worldwide, amassing considerable experience of their use and safety.
This guide has been jointly developed by the EMA and European commission with the objective of providing healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars.

Category: Biosimilar Development and evidence, Kurki et al 2021

Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective

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This is a comprehensive analysis of prelicensing and postmarketing safety surveillance reports from the European Medicines Agency (EMA) of all biosimilar mAbs and fusion proteins approved before August 2020. The findings support the conclusion that EU-approved biosimilars are highly similar and interchangeable with their reference products, negating the need for additional systematic switch studies.​

Featured publications

Category: Biosimilars Development and evidence European Commission

Biosimilars in the EU: Information Guide for Healthcare Professionals

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The European Commission has prepared this paper in order to provide payers, physicians and patients with adequate information on biosimilars. It gives a detailed overview of biologics and biosimilars, regulation and development of biosimilars, potential economic consequences of using biosimilars as well as Q&A sections for each of the key stakeholders.

Category: Biosimilars Development and evidence Kurki P, et al.

Interchangeability of Biosimilars: A European Perspective

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The introduction of biosimilars has shown that even complex proteins used for chronic disease treatment can be successfully copied. This in turn triggered discussions on aspects such as interchangeability between biosimilars and their reference products as well as immunogenicity profile of biosimilars.

Category: Biosimilars Development and evidence>Wolff-Holz E, et al.

Evolution of the EU Biosimilar Framework: Past and Future.

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Steering committee

Get introduced to our esteemed faculty members.

Prof. Hubertus H. Nietsch

Prof. Hubertus H. Nietsch

Martin-Luther University of Halle-Wittenberg, Halle (Saale), Germany

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Prof. Luis Puig

Prof. Luis Puig

Director of the Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

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Prof. Hendrik Schulze-Koops

Prof. Hendrik Schulze-Koops

Head of the Department of Rheumatology, Munich University Hospital, Munich, Germany

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