Arex Advisor published an expert article summarizing the rapid evolution of biosimilar regulation and the EMA Concept paper proposing a revision of the Guideline on Similar Biological Medicinal Products last revised in 2015.

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Expert article: Biosimilar development – Scientific advances behind new EMA guidelines The rapid evolution of biosimilar regulation over the past decade is reflected by…

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Company

Arex Advisor

Arex Advisor offers regulatory affairs expertise to the pharmaceutical and biotech industry.

Industry
Pharmaceutical Manufacturing
Location
Stockholm, SE
Company size
11–50 employees

About Arex Advisor

We are committed to the process of bringing medicines to the market, without detours. Our mission is to help leaders and companies bring their projects to commercialization. We are passionate about the development process, leading to submission and a successful commercialization of important medicines – which ultimately helps to improve the lives of patients. Arex is employee owned. We build our company on partnership – leading to long term relationships and a dedicated team. We are a tight-knit team of experienced specialists who unite in our client-committed view and our strong set of values. We combine our passion for the development process with a strategic mindset for project commercialization. Always working towards new and better ways of helping our clients. Our experts offer a combination of strategic advice and operational expertise throughout your journey from early development to commercialized product. We help you reach your desired destination.

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