Home / Biosimilars

Biosimilars

News

Japanese approval for insulin glargine biosimilar posted 30/01/2015

Partners Eli Lilly and Boehringer Ingelheim confirmed on 19 January 2015 that they had received Japanese regulatory approval...

Adalimumab similar biologic launched in India posted 30/01/2015

Indian generics maker Zydus Cadila announced on 9 December 2014 the launch of its adalimumab similar biologic in India.

Biosimilar etanercept submitted for approval in EU posted 23/01/2015

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 21...

Mabion starts phase III trial for rituximab biosimilar posted 23/01/2015

Polish biologicals company Mabion announced on 25 November 2014 that it had received the consent of the appropriate regulator...

Hospira submits application to FDA for epoetin alfa biosimilar posted 16/01/2015

US-based injectables specialist Hospira announced on 12 January 2015 that it had submitted a Biologics License Application (B...

 

Research

No relevant difference in ADRs from biosimilars and originators posted 30/01/2015

A study of adverse drug reactions reported in Italy has shown no difference between the number and type of side effects repor...

Filgrastim biosimilar has similar safety and efficacy to Neupogen posted 23/01/2015

A filgrastim biosimilar (EP2006) from Sandoz, the generics division of Swiss pharma giant Novartis, has shown similar safety...

Biocomparable has comparable safety and efficacy to originator erythropoietin in haemodialysis patients posted 22/01/2015

A study of the treatment of patients with chronic kidney disease undergoing haemodialysis with ‘biocomparable’ and originator...

Extrapolation of indications in biosimilars: infliximab posted 12/01/2015

Physicians may not be well informed about the scientific concept underlying the principle of extrapolating* indications for b...

Phase I study shows darbepoetin alfa biosimilar to be well tolerated posted 09/01/2015

Chong Kun Dang Pharmaceutical (CKD Pharma) announced on 18 November 2014 the successful completion of its phase I pharmacokin...

 

General

Biosimilars applications under review by EMA – December 2014 posted 30/01/2015

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A leg...

‘Similar biologics’ approved and marketed in India posted 30/01/2015

Last update: 30 January 2015There have been established guidelines for approving generic versions of small molecule chem...

Biosimilars approved in Europe posted 30/01/2015

Last update: 30 January 2015In the European Union (EU), a legal framework for approving biosimilars was established in 2003....

Glossary of key terms posted 15/01/2015

Last update: 12 January 2015Confusion may sometimes surround terms used in the fields of generics and biosimilars. This...

Biosimilars approved in Japan posted 05/12/2014

Last update: 5 December 2014In Japan, the regulatory body for the approval of medicines, including biologicals, is the M...

Generics News Research General

more

Biosimilars News Research General

more