Blog

EMA guidelines

    The most part of this information is from EMA website. This part is a transcription of the information available in EMA website. “This page lists the European Medicines Agency’s scientific guidance documents on biosimilar medicines. Due to the fact that there are is a lot of documentation, we are going to divide the guidelines in […]

    The most part of this information is from EMA website. This part is a transcription of the information available in EMA website.

    “This page lists the European Medicines Agency’s scientific guidance documents on biosimilar medicines.

    Due to the fact that there are is a lot of documentation, we are going to divide the guidelines in 3 posts:

Sin comentarios

What is the procedure to authorize a biosimilar in the European Union?

    Like all medicines, a biosimilar medicine needs to receive a marketing authorisation before it can be commercialised. Biosimilars are approved by the European Commission (EC) through a European centralized procedure, which is overseen by the EMA.

    Like all medicines, a biosimilar medicine needs to receive a marketing authorisation before it can be commercialised. Biosimilars are approved by the European Commission (EC) through a European centralized procedure, which is overseen by the EMA. (more…)

Sin comentarios

Is a biosimilar as safe and efficacious as the biological reference medicine product?

    Yes, a biosimilar is as safe and efficacious as the biological reference medicine product. For a biological product, whether biosimilar or original, to be launched in the European Union, it must first be assessed by European Medicines Agency (EMA) and then authorised by the European Commission (EC). The same EMA evaluators do assess both potential […]

    Yes, a biosimilar is as safe and efficacious as the biological reference medicine product. For a biological product, whether biosimilar or original, to be launched in the European Union, it must first be assessed by European Medicines Agency (EMA) and then authorised by the European Commission (EC). The same EMA evaluators do assess both potential innovator biotechs and biosimilars, and the review process for both types of products does therefore follow the same rigorous standards. These EMA standards, which have influenced other regulatory authorities (including WHO), have been specifically designed to guarantee a comparable degree of safety and efficacy as that of the originator. In addition to this biosimilar development review process, which is founded on a comprehensive comparability exercise, the available clinical evidence/knowledge of the original product provides further guarantees and safeguards for the therapeutic reliability of these biosimilars in clinical practice. Once approved in the EU, a biosimilar is just another biotech product, with the same guarantees required of the original.

    In general terms, you can find all the information available in EMA webpage http://www.ema.europa.eu/ema/

Sin comentarios

What is the difference between a generic and a biosimilar?

    A Generic is a chemically derived medicinal product, usually a simple, homogeneous small molecule, whose bioequivalence must be demonstrated. However, a Biosimilar is a medicinal product of biological origin, usually with a complex structure, and large proteins (such as antibodies) that are subject of heterogeneity. As a result of that heterogeneity, any variation must be […]

    A Generic is a chemically derived medicinal product, usually a simple, homogeneous small molecule, whose bioequivalence must be demonstrated. However, a Biosimilar is a medicinal product of biological origin, usually with a complex structure, and large proteins (such as antibodies) that are subject of heterogeneity. As a result of that heterogeneity, any variation must be assessed to ensure that there is no therapeutic consequence for the patient, and also the biosimilarity needs to be demonstrated through rigorous comparisons of efficacy and safety.
    Therefore, the regulatory requirements of the European Medicines Agency (EMA) for the development of biosimilars are more demanding than for developing generics.

    In general terms, you can find all the information available in EMA webpage http://www.ema.europa.eu/ema/

Sin comentarios

What is a biosimilar?

    The European Medicines Agency (EMA) defines a biosimilar or a similar biological medicinal product as “a medicinal product which is similar to a biological medicinal product that has already been authorised (the ‘biological reference medicinal product’). The active substance of a biosimilar medicinal product is similar to that of the biological reference medicinal product. The […]

    The European Medicines Agency (EMA) defines a biosimilar or a similar biological medicinal product as “a medicinal product which is similar to a biological medicinal product that has already been authorised (the ‘biological reference medicinal product’). The active substance of a biosimilar medicinal product is similar to that of the biological reference medicinal product. The name, appearance and packaging of a biosimilar medicinal product may differ from those of the biological reference medicinal product. It may also contain different inactive ingredients”. The pharmaceutical form, strength, and route of administration of the similar biological medicinal product should be the same as that of the reference medicinal product.

    The active substance of a similar biological medicinal product is a known biological active substance that is similar to the one of the reference medicinal product.

    A similar biological medicinal product and its reference medicinal product are expected to have the same safety and efficacy profile and are generally used to treat the same conditions.

    In general terms, you can find all the information available in EMA webpage http://www.ema.europa.eu/ema/

Sin comentarios
More on Curaxys
We focus on the research, production and commercialization of recombinant proteins added value through the utilization of CuraMab® with specific human cell lines
Our expression system allows us to reach of recombinant protein levels that are clearly above those currently available.
We developed a downstream technological platform on the basis of our own laboratory data.
Copyright 2012 Curaxys. All Rights Reserved
Legal Advice