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Mandatory and non-mandatory switching for biosimilars Biosimilars/Research | Posted 01/03/2019

Glintborg and co-authors responded to the comments made by Marc Scherlinger and Thierry Schaeverbeke on their paper ‘To switch or not to switch’, which reported the results of biosimilar etanercept...

Monoclonal antibody copy biologicals accepted for review in China Biosimilars/News | Posted 01/03/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted applications for approval of two monoclonal antibody copy biologicals (...

Positive phase III results for rituximab biosimilar ABP 798 Biosimilars/Research | Posted 01/03/2019

Biotech giant Amgen, and its partner Allergan, announced on 24 January 2019 positive data from a phase I/III study of its rituximab biosimilar (ABP 798) compared to Rituxan (rituximab).

The 700-dollar vitamin: excessive generics prices in the US Generics/Research | Posted 01/03/2019

Authors from Johns Hopkins University School of Medicine discuss excessive prices for generics in the US, using vitamin K1 as an example [1].

Australia plans reform of its generics authorization process Policies & Legislation | Posted 01/03/2019

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), announced on 7 February 2019 a public consultation into proposed improvements to its generics authorization process.

Pfizer drops five preclinical biosimilar programmes Biosimilars/General | Posted 01/03/2019

US pharma giant Pfizer confirmed on 15 January 2019 that it had terminated five of its preclinical biosimilar programmes after looking at the results of the company’s annual investment review.

USP action plan for generics and FDA new innovation office Generics/General | Posted 01/03/2019

The US Pharmacopeia (USP) has issued an action plan to promote generics and the US Food and Drug Administration (FDA) has announced the creation of a new office for drug innovation.

Mylan launches Advair generic at 70% discount Generics/News | Posted 01/03/2019

US-based drugmaker Mylan announced on 12 February 2019 the launch of Wixela Inhub (fluticasone/salmeterol inhalation powder, USP) at a list price 70% less than the originator product, GlaxoSmithKli...