Biosimilars
The economic impact of biosimilars in the US
Biologicals are large molecule compounds used to treat rare or complex diseases. Between 2013 and 2014, spending on specialty drugs, including biologicals, increased 32.4%, while spending on small-molecule drugs increased by just 6.8%. By 2016, eight of the 10 top-selling drugs are expected to be biologicals.
Positive clinical data for three anti-TNF-α biosimilars
Results of studies of three biosimilars from Samsung Bioepis, Benepali (etanercept), Flixabi (infliximab) and candidate biosimilar SB5 (adalimumab), have shown ‘comparable outcomes with regards to both the efficacy and safety of treatment’ when compared to their respective reference products, according to the company [1-3].
Doctors want more details in biosimilars labelling
In the European Union (EU), labels (Summaries of Product Characteristics, SmPCs) for biosimilars and their reference products are, in many instances, almost identical despite different data requirements for the authorization of biosimilars.
Mylan presents comparability data for trastuzumab biosimilar
Generics giant Mylan Pharmaceuticals (Mylan) presented robust data from its biosimilar trastuzumab programme at the American Society of Clinical Oncology (ASCO) Annual Meeting ASCO 2016 held in Chicago, USA on 3–7 June 2016.
Real-world safety data for epoetin alfa biosimilar
A 2-year post-marketing study of the epoetin alfa biosimilar Binocrit has found the biosimilar to be safe in daily clinical practice, according to the authors [1].
Health Canada approves Inflectra biosimilar for extra indications
US-based generics maker Hospira, now part of Pfizer, announced on 14 June 2016 that its infliximab biosimilar Inflectra had received approval from Canada’s medicines regulator, Health Canada, in three extra indications.
Biosimilar rituximab in biological naïve rheumatoid arthritis patients
Cost remains a major constraint in the use of originator biologicals in rheumatology in developing countries, paving the way for ever increasing usage of biosimilars. However, apart from the cost, their efficacy and safety are of tremendous interest to clinicians in both developing and developed worlds.
Insulin biosimilar meets primary endpoint in phase III studies
US pharma giant Merck announced on 13 June 2016 positive results from two phase III studies evaluating its insulin glargine biosimilar (MK-1293).
Improvement in uptake of biosimilars in Spain
Author Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain found that there has been an increase in the uptake of biosimilars in Spain since indicators were introduced [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].
