news
Former FDA Commissioner joins Pfizer’s board of directors
Former FDA Commissioner, Scott Gottlieb, who stepped down from the administration in April, has joined Pfizer’s board of directors.
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Biosimilars
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Biopharmaceutical contract manufacturing market expected to rise 10.6 percent
A study has predicted that the global biopharmaceutical contract manufacturing market will grow by 10.6 percent from 2017 to 2027.
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More effective, safe drugs drive biobetter market growth
The global biobetters market is set to increase due to demand for higher efficacy and safer drugs.
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Proposed biosimilar accepted for review by EMA
The EMA has accepted Prestige BioPharma’s marketing application for its trastuzumab biosimilar.
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British Columbia first province to switch patients to biosimilars
British Columbia has said it will switch as many as 20,400 patients from three branded biologic drugs to cheap biosimilars.
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Patent litigation for adalimumab resolved in the US
AbbVie has announced that it has resolved its US HUMIRA (adalimumab) litigation with Boehringer Ingelheim.
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…
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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...
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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...
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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...
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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.
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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...
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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…
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Pharma patent challenges for 2018
Christof Hohne, partner at patent law firm EIP, discusses second medical use claims and compulsory licences...
