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FDA approves adalimumab biosimilar Hadlima Biosimilars/News | Posted 16/08/2019

Korea-based biosimilars maker Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 24 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its ada...

Korean firms to launch biosimilars in Japan despite trade tensions Biosimilars/News | Posted 16/08/2019

Despite increasing trade tensions between Japan and Korea, two Korean firms have confirmed that they intend to move ahead with the launch of their darbepoetin alfa biosimilars in Japan in the secon...

WHO essential medicines list: new lung cancer medicines rejected Pharma News | Posted 16/08/2019

The World Health Organization’s (WHO) list of ‘essential medicines’, received a biennial update on 9 July 2019. It added 28 drugs but left out several new treatments for lung cancer.

Biosimilars applications under review by EMA – July 2019 Biosimilars/General | Posted 16/08/2019

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval...

Positive phase III results for bevacizumab copy biological IBI305 Biosimilars/Research | Posted 16/08/2019

Innovent Biologics (Innovent) has presented positive phase III results for its bevacizumab copy biological IBI305 at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO).

Prices for infectious disease treatments and how to reduce them Generics/Research | Posted 16/08/2019

A recent review from Harvard Medical School explores the factors fuelling high drug prices in the US, suggesting several ways to avoid exorbitant pricing, including increasing clinician awareness o...

IPRP expands and all EU Member States now included in EU-US MRA Policies & Legislation | Posted 16/08/2019

During the June 2019 International Pharmaceutical Regulators Programme (IPRP) management committee meeting in Amsterdam, The Netherlands, it was announced that Iran’s National Regulatory Authority...

Extensive characterization of biosimilars: a pegylated filgrastim study Biosimilars/Research | Posted 16/08/2019

Pegfilgrastim, is a 38 kDa, pegylated form of filgrastim, with a 20 kDa monomethoxypolyethylene glycol (mPEG) molecule covalently bound to the N-terminal methionyl residue of filgrastim developed b...