news
Patent litigation for adalimumab resolved in the US
AbbVie has announced that it has resolved its US HUMIRA (adalimumab) litigation with Boehringer Ingelheim.
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Biosimilars
whitepaper
Whitepaper: Analytical criteria in bacterial endotoxin testing using LAL and rFC
This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate…
news
EU measures in support of generic pharmaceuticals producers
The EU is adopting new rules which should boost the competitiveness of EU producers of generic medicines and biosimilar products...
news
Aspirin enteric-coated tablets market report 2018-2023
A market report on the aspirin enteric-coated pharmaceutical industry outlines current trends and opportunities for growth from 2018 until 2023...
news
Biomanufacturing sector set to ‘boost its efficiency’
The next five years will see game-changing improvements made in upstream, downstream and continuous bioprocessing, predicts one industry specialist...
news
FDA approves first biosimilar to Neulasta
The U.S. Food and Drug Administration has approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment.
news
FDA approves first epoetin alfa biosimilar for the treatment of anaemia
The FDA has approved Retacrit as a biosimilar to Epogen/Procrit for the treatment of anaemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection...
news
EC approves first biosimilar Mvasi for the treatment of cancer
The European Commission has granted marketing authorisation for Mvasi for the treatment of certain types of cancer...
article
Obstacles to success for biosimilars in the US market
Since 2007, the EMA has approved 31 biosimilar products1 and refused or withdrawn around five. The FDA, however, since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2009,2 has licensed six products under PHS 351(k) of the Public Health Service (PHS) Act; approved one product under…
article
Pharma patent challenges for 2018
Christof Hohne, partner at patent law firm EIP, discusses second medical use claims and compulsory licences...
news
Ogivri approved as the first biosimilar against certain breast and stomach cancers
The FDA has approved Ogivri as a biosimilar to Herceptin for the treatment of patients with breast or metastatic stomach cancer whose tumours overexpress the HER2 gene...
news
British Biosimilars Association appoints new chair
The BBA, the representative group of biosimilar manufacturers in the UK, has announced that Kavya Gopal will become its new chair with immediate effect...
news
Sandoz proposed biosimilar pegfilgrastim accepted by EMA
Sandoz has announced that its biosimilar pegfilgrastim has been accepted by the EMA for regulatory review...
webinar
Application of HDX-MS for drug discovery and development
13 October 2017 | By Thermo Fisher Scientific
In this webinar, theory and practice of HDX-MS will be discussed in conjunction with the topics of pharmaceutical industry...
news
FDA approves first biosimilar for the treatment of cancer
Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and cervical cancers…
