Biosimilars/Research
Uptake of biosimilars increasing in Spain
Use of biosimilars in Madrid, Spain, has increased after approaches were introduced to try and improve uptake of biosimilars in the country, according to Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain [1].
Approaches to increase uptake of biosimilars in Spain
Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, describe approaches that have been introduced in Spain to try and improve uptake of biosimilars in the country [1].
A strategic approach to increase uptake of biosimilars in Spain
Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, describe the strategic approach that has been introduced in Spain to try and improve uptake of biosimilars in the country [1].
Improving uptake of biosimilars in Spain
Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, investigated how efforts to improve the uptake of biosimilars in the country have been working.
Assessing the immunogenicity of monoclonal antibodies
Safety is a major concern when it comes to biologicals (including biosimilars) and the most critical safety concern is immunogenicity. This is especially important in monoclonal antibody (mAb) biologicals, which are large molecules with complex structures and functions and which represent the largest class of biologicals [1].
Sharing biosimilars substitution information with patients critical
On 12 October 2013, California Governor Jerry Brown vetoed legislation known as SB 598. Some believed this bill would have impeded access to biosimilars, but others believe it would have supported and strengthened patient-provider communication [1].
More immunogenicity data needed for biosimilar mAbs
Eight therapeutic monoclonal antibodies (mAbs) will lose EU and US patent protection before 2020, making way for a new class of biosimilar. The promise of biosimilar mAbs is enticing, but these are more complex molecules than current biosimilars and it is unclear how their similarity with originator mAbs will be tested.
The future of biosimilar mAbs in Europe
Biosimilars – products that are similar to originator biological medicinal products – have had a positive impact on healthcare systems. But it takes up to four years following market approval before biosimilars are accepted by the clinical community and by the people holding the purse strings. Now, a new class of biosimilar –monoclonal antibodies (mAbs) – is set to challenge the system further, writes Professor Andrea Laslop of the Austrian Agency for Health and Food Safety [1].
Immunogenicity of biologicals: the role of post-translational modifications
Although produced under strict quality control(s) nascent endogenous proteins and glycoproteins (P/GP) are structurally heterogeneous and subject to further structural changes throughout their in vivo life cycle. A nascent polypeptide chain may be subject to co-translational modifications (CTMs) as it is extruded from the ribosome tunnel, e.g. the addition of oligosaccharide; edited for correct folding and initial oligosaccharide processing within the endoplasmic reticulum and subject to post-translational modifications (PTMs) during passage through the Golgi apparatus. The functional activity of a P/GP may be dependent on further chemical modifications (CMs), e.g. deamidation, enzymatic cleavage. These heterogeneities are compounded when determining the structure of a purified P/GP because further CMs may be introduced during its isolation, purification and characterization [1].
Extrapolation of indications in biosimilars: infliximab
Physicians may not be well informed about the scientific concept underlying the principle of extrapolating* indications for biosimilars. This in turn may lead them to distrust biosimilars, leading to a lower than expected uptake in Europe, especially in extrapolated indications. Members of the European Medicines Agency’s (EMA) Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP) address these concerns using extrapolation of indications in biosimilar infliximab as an example [1].
