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Incomplete processing in recombinant streptokinase

A study investigating the impact of incomplete processing on streptokinase activity has found that ‘similar biologics’ or different batches of the biological may have different potencies, depending on the degree of amino-terminal methionine processing and on the pharmacopoeial assay method used, affecting the dosage patients receive [1].

Variation in recombinant streptokinase

A study of blood clot dissolving drug streptokinase has highlighted the mantra of ‘the process is the product’ in the case of biologicals [1].

Clinical trials for adalimumab biosimilars

As part of their investigation into biosimilars for the treatment of psoriasis, researchers from the Charité – Universitätsmedizin Berlin, Germany, carried out a systematic review into clinical trials for adalimumab biosimilars [1].

Biosimilar filgrastim highly similar to originator filgrastim

A study comparing Sandoz’s filgrastim biosimilar (Zarzio) with originator filgrastim (Neupogen) has shown that they are highly similar in terms of their structure and function [1].

Clinical trials of biosimilars for psoriasis treatment

Tumour necrosis factor-alpha (TNF-alpha) is a cytokine, or protein, that prompts the body to create inflammation. In psoriasis and psoriatic arthritis, there is excess production of TNF-alpha in the skin or joints. Therefore, drugs that block TNF-alpha, such as Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab) and Stelara (ustekinumab), can be used to treat psoriasis and psoriatic arthritis.

Considerations when promoting generics prescribing in the US

Sarpatwari and co-authors investigate the legal and ethical consideration for promoting generics prescribing in the US and how this might apply to biosimilars [1].

Adalimumab biosimilar meets primary endpoints in phase I study

US biotech company Oncobiologics announced on 12 February 2015 that ONS-3010, its adalimumab biosimilar candidate, met the primary endpoints in its first clinical study.

Promoting generics prescribing in the US

Sarpatwari and co-authors discuss physician-centered strategies used to promote generics prescribing in the US and how such strategies might apply to biosimilars [1].

Substitution of biosimilars in the US

The approval of the first biosimilar in the US, Zarxio (filgrastim), on 6 March 2015 [1], prompted Sarpatwari and co-authors to investigate how biosimilars might be substituted for originator biologicals in the US [2].

Substitution of generics in the US

In order to evaluate how strategies to promote the prescribing of generics by physicians in the US might apply to biosimilars, Sarpatwari and co-authors discuss the types of substitution possible with generics [1].

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