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Successful cloning of the human EPO gene () allowed for production of recombinant human erythropoietin (rHuEpo), and later the approval to treat patients with anaemia (low Hb levels) in humans.

Alternative biologics are not biosimilar and have not been approved as biosimilar, and they should be clearly distinguished from approved biosimilars in discussions about the new biosimilars pathway implemented in the US.

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The increase was partially offset by a decrease in the core income contribution from Roche to USD 163 million in the first quarter of 2016 due to an adjustment for actual results of the fourth quarter of 2015, compared to USD 171 million in the prior-year quarter.

Incidences of Treatment Emergent Adverse Events (TEAEs), related TEAEs, treatment-emergent Serious Adverse Events (SAEs), and related SAEs will be summarized by the medical dictionary for regulatory activities (MedDRA) primary system organ class (SOC) and preferred term overall and, in addition, stratified by severity of the events.

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Sandoz Japan announces generic pharmaceutical alliance with Nipro Corporation, focusing on a broad range of cross-licensing and co-development opportunities for the Japanese generics market.

Pharmacopeial Convention (USP) endorsed a draft World Health Organization (WHO) proposal to create a unique suffix for biologic drugs, including biosimilars.

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Die AkdÄ empfiehlt, den Patienten in der Zeit nach der Umstellung von einem Referenzprodukt auf ein Biosimilar engmaschig zu überwachen.

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