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WHO asks for comments on new biosimilar Q&A Guidelines | Posted 14/09/2018

As part of plans to provide additional clarification of its 2009 guidelines on the evaluation of biosimilars, the World Health Organization (WHO) has drafted a new document providing answers to que...

Japan approves first darbepoetin alfa biosimilar Biosimilars/News | Posted 14/09/2018

Japan-based Kyowa Hakko Kirin announced on 16 August 2018 that it had gained Japanese approval for its darbepoetin alfa biosimilar.

Hospital use of generic drugs increases adoption by community pharmacies Generics/Research | Posted 14/09/2018

A recent Japanese study reveals that hospital adoption of generic drugs can also promote their use by community pharmacies. The researchers found that hospital adoption of generic drugs increased c...

Extension of indications and manufacturing approval for biologicals in the US Biosimilars/General | Posted 14/09/2018

Filgrastim biosimilar Granix (tbo-filgrastim) has been approved for extended indications and Samsung BioLogics has received approval to manufacture a monoclonal antibody drug product.

Novartis accused of pay-for-delay, while Amgen sues over generic thyroid drug Generics/General | Posted 14/09/2018

Novartis are facing a lawsuit for attempts to prevent generic versions of their hypertension treatment Exforge, and Amgen announce they will be suing Accord Healthcare for patent infringement on th...

Comparison of biosimilar and originator bevacizumab in NSCLC Biosimilars/Research | Posted 14/09/2018

A study carried out by international researchers reported results from a comparative clinical study of PF‑06439535, a candidate bevacizumab biosimilar compared to originator bevacizumab, in patient...

AbbVie ruled to pay nearly US$450 million for antitrust violations Policies & Legislation | Posted 14/09/2018

AbbVie and their partner firm Besins Healthcare have been ordered by the Federal Trade Commission (FTC) to pay US$448 million for preventing generics competition to their testosterone product Andro...

Australia approves first capsule-form Viagra generic Generics/News | Posted 14/09/2018

Singapore-based iX Biopharma announced on 6 August 2018 that it had received approval from Australia’s Therapeutic Goods Administration (TGA) for its sildenafil drug, which is delivered in an oral...