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...
List view / Grid view
Biosimilars
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Since 2007, the EMA has approved 31 biosimilar products1 and refused or withdrawn around five.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…
news
Drug approval harmonisation shows savings potential
Researchers have compared the regulatory authorities responsible for approving drugs and medical products to verify their effectiveness and safety...
article
Risky endeavours for biosimilars market
Bringing a biosimilar from early development to market is a risky endeavour say Magnus Franzen (left) and Chris Isler, biosimilar experts at PA Consulting Group...
news
BIOCAD does its sums for growth
Russian biotech company BIOCAD plans to leverage competitive advantages to take 5% of the European medicines market
news
UK trails behind EU in cancer diagnosis & treatment
A new report shows that the UK is trailing behind the rest of Europe in the diagnosis and treatment of cancer.
news
Sandoz receives EU approval in Europe for Rixathon (biosimilar rituximab)
The EC has approved Sandoz’ Rixathon (biosimilar rituximab) for use in Europe. Rixathon is approved for use in all indications of the reference medicine...
news
AAM praises Supreme Court Ruling granting access to biosimilars
The Association for Accessible Medicines (AAM) applauded the US Supreme Court’s decision this week in Sandoz Inc. v. Amgen Inc. that will help speed patient access to biosimilar versions of expensive brand-name biologic medicines.
whitepaper
Whitepaper: Antibody capture and analysis
The development and production of antibody biopharmaceuticals and biosimilars require specific chromatographic tools for efficient purification and QC analysis to improve process economics, safety, and time-to-market.
