biosimilars
Merck initiates global phase III clinical study
Merck has initiated a global Phase III clinical study of MSB11022, a proposed biosimilar of adalimumab, in chronic plaque psoriasis more »
Mar 2, 2016 10:30 AM News
New report asses the effects of biosimilar competition across Europe
IMS Health has published a new report which provides an assessment of the effects of biosimilar competition on price and volume across Europe more »
Dec 16, 2015 2:09 PM News
The NHS releases biosimilar medicines publication
NHS England has released a new publication ‘What is a biosimilar medicine? more »
Sep 25, 2015 5:21 PM News
EU approves Pfizer's buyout of Hospira
The EU has approved Pfizer's $15 billion takeover of US rival Hospira after the pharma giant promised to sell certain drugs in light of competition concerns. more »
Aug 6, 2015 11:03 AM News
BGMA welcomes Inflixmab biosimilar resource
The BGMA has welcomed the publication by the NICE of an implementation pack to support the introduction of biosimilar versions of Infliximab. more »
Aug 4, 2015 12:08 PM News
BioOutsource opens Glasgow facility
BioOutsource, part of Sartorius Stedim Biotech Group, has opened a facility in Glasgow, Scotland, doubling its biologics contract testing and biosimilar characterisation capacity and creating 50 jobs. more »
Jul 29, 2015 11:29 AM News
EPIRUS and Polpharma strike biosimilars deal
EPIRUS Biopharmaceuticals and Polish generics company Polpharma Group have struck a multi-product, multi-region profit-sharing deal for select EPIRUS biosimilars, representing $6 billion in innovator sales in the specified territories. more »
Jul 15, 2015 7:52 AM News
amp biosimilars successfully out-licenses first biosimilar
amp biosimilars has announced its first successful out-licensing of biosimilar ABY-018, a humanised monoclonal antibody. At present, there are four biosimilars in the ampb product pipeline. more »
May 29, 2015 10:30 AM News
Injectable biosimilars ‘hitting their stride’
After much anticipation, biosimilars are beginning to hit their stride, according to Greystone Research. more »
Mar 18, 2015 9:46 AM News
Biosimilars on a global scale
Lini Subin, senior manager, regulatory affairs, ELC Group, discusses how EMA opens doors for global biosimilar development. more »
Mar 16, 2015 3:11 PM Opinion
The rheumatoid arthritis drug market will grow to $18.2 billion in 2023
Growth will be driven by the uptake of oral Jak inhibitors and non-TNF-alpha biologics more »
Sep 18, 2014 12:35 PM
Biosimilar Retacrit effective in chemotherapy-induced anemia
Results show that the company's European biosimilar epoetin, Retacrit (epoetin zeta) was effective and well tolerated in the management of chemotherapy-induced anemia in patients with solid tumours, lymphoma and myeloma. more »
Jul 24, 2014 1:36 PM
FDA accepts Sandoz application for biosimilar filgrastim
The reference product is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant. more »
Jul 24, 2014 11:00 AM
BIA and ABPI jointly launch new communication materials to enhance understanding of biosimilar medicines
The materials provide an interesting overview on this ever-growing market at a significant time, with biological medicines now amongst today’s most important medicines. more »
Jul 23, 2014 10:57 AM
Glasgow Biosimilar Centre of Excellence Opens as Global Demand Surges
BioOutsource, a biologics contract testing and biosimilar characterisation services provider to the biopharmaceutical industry, has announced the opening of a new Biosimilar Centre of Excellence in Glasgow, Scotland. The new facility will double... more »
Feb 5, 2014 11:24 AM Technology
Range of Off-the-Shelf Testing Methodologies Support Biosimilar Characterisation
BioOutsource, a leading international contract testing organisation (CTO), has consolidated its position as a leading expert in the biological analysis of biosimilar monoclonal antibodies for the biopharmaceutical industry. more »
Sep 23, 2013 2:56 PM Technology
Proposed guideline on LMWHs in biosimilars
The European Medicines Agency (EMA) announced on 31 January 2013 that it had released a draft guideline to revise the agency’s current guideline on biosimilars containing low molecular weight heparins (LMWHs), a type of medical product often used... more »
Aug 5, 2013 4:22 PM Regulatory Affairs Blog
Biosimilars sector from EU and US perspectives
Biosimilar medicines, one of the fastest growing sectors of the industry, constitute a major share of pharmaceutical expenditure in the EU, the US and globally. From a regulatory perspective, they are a new paradigm in drug development, similarly... more »
Mar 26, 2013 12:10 PM Regulatory Affairs Blog