Nature Biotechnology - Biosimilars—why terminology matters. According to the EU, a biosimilar medicinal product is a copy version of an already authorized biological medicinal product (the ...

2. EMA, European Medicines Agency adopts first positive opinion for a similar biological medicinal product (January, 2006). www.ema.europa.eu. 3. EMA, Guideline on non-clinical and clinical ...

The assessment of therapeutic equivalence carries important consequences for how a medicinal product is managed, particularly concerning the choice of the prescribing physician and the possibility ...

Similarly to other innovative medicinal products, demonstrating the quality, efficacy and safety of these living medicines will require an innovative regulatory and technical approach. Advanced Search ...

The European Medicines Agency (EMA) has adopted a guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies (MAbs), which will be released shortly for public consultation.

A biological medicine is any medicinal product made by or derived from a biological (natural) source, for example, an animal cell or microorganism. The first biological medicine to be approved for use ...

The European Union actually blazed the trail for biosimilars in 2005 when it established guidelines for "similar biological medicinal products" (i.e., biosimilars) (2). Subsequently, Japan established ...

Similar to all products intended to prevent or treat diseases, LBPs will have to be registered as medicinal products to reach market in the US and in Europe.