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biosimilars

The US Food and Drug Administration (FDA) has approved Sanofi’s short-acting insulin (Admelog — insulin lispro injection) as a ‘follow on’ product to treat diabetes. more

12 Dec 2017 12:19 News

Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. more

8 Dec 2017 15:00 News

The US Food and Drug Administration (FDA) has approved the first biosimilar for the treatment of certain breast and stomach cancers, Ogivri (trastuzumab-dkst). more

5 Dec 2017 14:49 News

Russian biotechnology company, BIOCAD, has revealed plans to enter the European market with oncological and autoimmune medicines. more

31 Oct 2017 10:45 News

The findings from the final section (part iii) of the CPhI Annual Report have been announced by event organisers UBM. more

31 Oct 2017 10:42 Analysis

Harriet Lewis, ABPI's Medicines Optimisation Lead, discusses the future of biosimilars in the UK asking the pertinent question: will they revolutionise healthcare? more

23 Oct 2017 10:00 Opinion

The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) of a biosimilar version of Neulasta (pegfilgrastim) to treat chemotherapy-induced neutropenia from Cinfa Biotech. more

6 Oct 2017 12:28 News

The US Food and Drug Administration (FDA) has approved Mvasi (bevacizumab-awwb) as a biosimilar to the cancer treatment Avastin (bevacizumab). This represents the first biosimilar approved by the regulatory body for cancer treatment. more

19 Sep 2017 13:47 News

Speaking at Expo conference in Manchester, the head of NHS England, Simon Stevens, unveiled an ambitious plan for the NHS as it approaches its 70th anniversary. more

13 Sep 2017 13:48 News

The European Commission (EC) has approved Samsung Bioepis’ Imraldi — a biosimilar referencing adalimumab (Humira) — for the treatment of 10 inflammatory conditions. more

29 Aug 2017 15:08 News

Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. more

21 Jul 2017 15:36 News

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion, recommending that biosimilar Imraldi be granted marketing authorisation. more

27 Jun 2017 11:52 News

Pfizer has provided an update on its biologics licence application (BLA) for its proposed epoetin alfa biosimilar after receiving a complete response letter (CRL) from the US Food and Drug Administration (FDA). more

26 Jun 2017 15:09 News

Data from a randomised controlled trial, presented at the International Conference on Malignant Lymphoma (ICML) has shown Truxima (CT-P10) to be non-inferior to the reference product in terms of overall and complete response rates more

15 Jun 2017 12:10 News

Narasimharaju SN, senior manager — regulatory affairs and Mac Kella, senior regulatory affairs executive at ELC Group assess whether biosimilars are really interchangeable in the EU. more

15 Jun 2017 09:20 , Opinion 1 Comments

The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorisation applications for biosimilars to AbbVie’s Humira (adalimumab) and Janssen’s Remicade (infliximab) from Sandoz more

6 Jun 2017 14:07 News

The latest report by business intelligence provider GBI research shows that new opportunities for biosimilar manufacturers are being presented through patent expiries of key biologics. more

13 Mar 2017 13:50 News

Pharmaceutical and biotech partnering company Mundipharma, is set to launch Truxima, the first biosimilar monoclonal antibody authorised by the European Comission (EC) for the treatment of cancers. more

23 Feb 2017 14:30 News

Asia’s pharmaceutical sector - how to achieve successful globalisation Words by JinHee Kang, senior regulatory expert - biosimilars, ELC Group more

News

A recent position paper, published by the European Society for Medical Oncology (ESMO) has stated how biosimilars can create opportunities for sustainable cancer care. more

19 Jan 2017 16:35 News