Biosimilar antibodies

Biosimilar antibodies are copycat products for therapeutic monoclonal antibodies that have already been approved after their patent expiry . Make Although a subset of simpler Biosimilars ( epoetins , FSH , G-CSF , somatropin , insulin , interferons ) represent, but are due to their much higher molecular mass , their complex tertiary and quaternary structure of their multiple post-translational modifications as well as their complex effector functions of these to delimit.

Admission

In September 2013, the European Medicines Agency (EMA ) approved a biosimilar antibody ( infliximab ) for the first time . The use of copycat drugs is intended to save costs in the healthcare system. In the conventional pharmaceutical market, this is done using so-called generics . The possible uses for the biosimilar antibodies are not exactly comparable and are regulated separately:

The approval of biosimilar antibodies in Europe is regulated by the EMA through a number of guidelines, which contain both general aspects in the development of biosimilars and also take into account the specific features of the development of biosimilar antibodies, such as: B. their relatively high immunogenicity potential. In principle, the EMA requires proof of similarity ( similarity ) to the original (reference product ) for the approval of a biosimilar antibody , but not the proof of patient benefit, as this was already provided in the approval studies with the original. A biosimilar antibody is approved by demonstrating similarity in an abbreviated, step-by-step procedure in which analytical (physicochemical) and functional ( in vitro ) methods are the first priority . If there is sufficient similarity in vitro, according to the regulations of the EMA, a significantly shortened clinical study program is sufficient to confirm the clinical equivalence . Here, equivalence studies are carried out between the original and the biosimilar antibody, in which differences in pharmacodynamics, efficacy and tolerability are to be excluded on the basis of surrogate endpoints . The area in which an effect is still considered to be equivalent is assessed by the EMA on a case-by-case basis.

safety

In order to be able to better evaluate the safety of these newly approved biosimilar antibodies, they will be marked with a black triangle on the tip in the product information after approval . This is intended to improve the recording of side effect reports in the spontaneous reporting system. This is relatively difficult, since biosimilar antibodies receive the identical INN ( English international non-proprietary name ) as the original preparation, making clear traceability more difficult. Therefore, in section 4.4 “Special warnings and precautions for use” of the product information for the original products, the documentation of the trade name in the patient file is required.

Overview

An overview of biosimilar monoclonal antibodies approved in the EU can be found in the article Biosimilars .

Individual evidence

1. ↑ ^{a b} Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues, EMA / CHMP / BMWP / 403543/2010 , Committee for Human Medicinal Products, May 30, 2012.
2. ↑ ANTIBODY Structure and Function
3. ↑ European Medicines Agency recommends approval of first two monoclonal-antibody biosimilars Recommendation marks extension of biosimilar concept to new product class , EMA press release, June 28, 2013.
4. ^ ^{A b} European Medicines Agency - Human regulatory - Multidisciplinary: biosimilar
5. ↑ Association of research-based pharmaceutical manufacturers, biosimilars ( Memento of the original from March 20, 2014 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. 
6. ^ European Medicines Agency - Human regulatory - List of medicines under additional monitoring
7. ↑ Medicinal products under additional surveillance , BfArM, accessed on April 18, 2019.
8. ^ WHO Informal Consultation on International Nonproprietary Names (INN) - Policy for Biosimilar Products, Geneva, September 4-5, 2006 .
9. ↑ Information for professionals on Remicade (infliximab)
10. ↑ Specialist information on MabThera (rituximab)

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