Bridging the accessibility gap

Treatment alternatives with proven safety and efficacy

While specialty biopharmaceuticals undeniably offer unique treatment options, they also impose immense cost pressures. Our specialty biosimilars are developed for a sustainable, global, and equal access to medicinal products.

A biosimilar is defined as a biological medicine which has been proven to be highly similar to an already marketed biological drug, the reference medicinal product (RMP). Due to tailored development programs, biosimilars are usually less expensive than their branded counterparts and can be marketed once the RMPs have lost their exclusivity rights and patent protections.

According to IMS Health the savings potential of biosimilars in US and EU is estimated to reach up to USD 110 bn by 2020.

Unlike chemical compounds, biologics, such as coagulation factors and monoclonal antibodies, are known to have an immanently complex structure and to be highly prone to small changes introduced in the manufacturing process. Hence, a biosimilar can never be precisely identical to its originator.


Notably, developers need to demonstrate that any minor difference observed between the biosimilar and the branded drug does not cause clinically meaningful differences in terms of safety, quality and efficacy 1. This given, every biosimilar approved under current regulations by healthcare authorities in highly regulated countries, e.g. in the EU, US, Korea or Japan, proved to have the identical safety and efficacy profile as the originator.


At Valerius, we dedicated ourselves to the development of non-orphan and orphan biosimilars for the treatment of life-threatening and rare diseases.

1 European Medicines Agency, Questions and answers on biosimilar medicines [EMA/837805/2011]


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