EMA issues Draft Guideline on Similar Biological Medicinal Products for public consultation

On 26 April, the Committee for Medicinal Products for Human Use (CHMP) published the draft "Guideline on Similar Biological Medicinal Products" for public consultation until 31 October 2013. This guideline is supposed to replace the Guideline on similar biological medicinal products (CHMP/437/04).

The purpose of this guideline is to describe the concept of similar biological medicinal products (hereby designated as “biosimilars”) and to outline the general principles to be applied. The CHMP guidelines addressing the planning and conduct of biosimilar comparability studies should always be read in conjunction with relevant scientific guidelines and legislative provisions in force in the Union. Companies developing biosimilars are invited to contact Regulatory Authorities to obtain further advice on their development, whenever there is a need for more detailed information than provided in the guidelines already available.

The development of biosimilars turned out to be much more complicated as the development of classic generics. To achieve and demonstrate the necessary biosimilarity is a real challenge for every developing company. During the last 1 2- years the responsible authorities tried to support the companies within Europe as well as in US (see our GMP News from 25 April 2013, 7 March 2012 and 20 June 2012).

The revision of the "Guideline on Similar Biological Medicinal Products" will be an additional step to outline the general principles to be applied to similar biological medicinal products (also known as biosimilars) as referred to in Section 4, Part II, Annex I to Directive 2001/83/EC. It describes and addresses the application of the biosimilar approach, the choice of the reference product and the principles of establishing biosimilarity.

Please also see for further reference:

• Guideline on Similar Biological Medicinal Products
• Submission Form for Comments