More Articles

Secrecy is an obstacle to the use of biosimilars in the US Biosimilars/Research | Posted 11/05/2018

Factors that Professor Frank believes may be affecting uptake include naming and interchangeability guidance, insurance payment arrangements and secrecy about manufacturing processes [1]. In this a...

Biosimilar etanercept Eucept approved in South Korea Biosimilars/News | Posted 11/05/2018

South Korea-based LG Chem has obtained regulatory approval to begin marketing and selling its etanercept biosimilar in Korea.

Safety of biosimilar infliximab in pregnant women with IBD Biosimilars/Research | Posted 11/05/2018

Introduction of the first biosimilar infliximab (CT‑P13, Remsima/Inflectra) for the treatment of inflammatory bowel diseases (IBDs) was aimed to reduce the healthcare cost burden and to increase th...

Use of PK as an endpoint for clinical switching studies Reports | Posted 11/05/2018

As part of the Food and Drug Administration’s (FDA) implementation of the Biologics Price Competition and Innovation Act of 2009, the agency published draft guidance on biosimilar interchangeabilit...

Biosimilars highlights for 2017 Biosimilars/General | Posted 11/05/2018

There are many product launches and various topics such as naming, extrapolation, interchangeability and switching of biosimilars in 2017 [1]. Important milestones achieved during 2017 were the bio...

EMA collaboration on oversight of API makers Generics/General | Posted 11/05/2018

The European Medicines Agency (EMA) announced on 12 April 2018 that it had published the International API inspection programme report for 2011−2016.

China introduces new policy to boost generics Policies & Legislation | Posted 11/05/2018

The State Council, China’s cabinet, unveiled a new policy whereby some generics manufacturers could qualify for a ‘high-tech enterprise’ designation that comes with a 15% corporate tax rate, compar...

Alvogen receives European approval for generic lenalidomide Generics/News | Posted 11/05/2018

US generics company Alvogen announced on 24 April 2018 that it had successfully concluded multiple registration procedures for its lenalidomide generic capsules.