generics companies.The expensive part of the process of developing biosimilars was always going to be the clinical work. But the overarching guidelines that the CHMP published on biosimilars (not specifically mAbs) in 2005 were rather vague on the nature of those trials. Indeed, the guidelines ...
The first biosimilar was approved in the EU in 2006, and since then the EU has approved the highest number of biosimilars worldwide. The EMA has issued scientific guidelines over the years to help developers conform to the strict regulatory requirements for biosimilar approval. “The expertise acq...
As a number of biological medicinal products come off patent by 2020 biosimilars are in the focus with regard to new market launches. Three guidelines published by the EMA supplemented by a number of product or class specific guidelines are designed to help preparing the documentation needed in ...
All medicines for human and animal use derived from biotechnology and other high-tech processes (including biosimilars) must be approved via the centralized EMA procedure. EMA has both general and product specific guidelines giving information on the requirements for biosimilar applications submitted to E...
Headquartered in the United Kingdom (UK), Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies se...
populations not studied in clinical trials, summary of treatment results, etc. The summary of minimum RMP requirements for different initial MAAs (full MA application, generic product, fixed combination product, biosimilars, etc.) allows the stakeholders to clearly understand the information t...
This is also the case for all other national competent authorities of the EU and EMA. The Austrian Federal Office for Safety in Healthcare issues a ... Christoph Baumg?rtel - 《Generics & Biosimilars Initiative Journal》 被引量: 15发表: 2012年 What is being measured, and by whom? Facili...
Headquartered in the United Kingdom (UK), Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. ...
2014 also saw positive opinions from the EMA on 40 new (nonorphan) drugs, three biosimilars, one drug for pediatric use, and 21 generic, hybrid, and informed consent applications. Included among the orphan drugs is ataluren (Translarna, PTC Therapeutics), the first medicine for the treatment ...
The EU’s Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorisation for 14 new medicines in its July meeting. The following novel medicines and biosimilars each received a positive opinion: Abrysvo (bivalent, recombinant), a vaccine to protect small infants...