News
RAPS: Biosimilars in the EU: New IMS Report Shows Savings Through Competition
11.05.2017
A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low.The
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EMA: New guide on biosimilar medicines for healthcare professionals
11.05.2017
The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. Biosimilars are biological medicines that
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FDA: Considerations in Demonstrating Interchangeability With a Reference Product
10.02.2017
This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing
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RAPS: FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars
05.01.2017
Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is
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RAPS: FDA Withdraws Document Calling on Biosimilar Developers to Submit 10 Random Suffixes
30.06.2016
The US Food and Drug Administration (FDA) on Tuesday withdrew a document submitted to the Office of Management and Budget (OMB) that offered new details on how biosimilar developers would submit
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FDA: Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification
09.06.2016
This guidance is intended to assist submitters of a biomarker for qualification that conduct nonclinical studies for which histopathology is used as a reference or truth standard (Zhou et al.
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GMP: Monoclonal antibodies as similar biotherapeutic products - Draft Guideline
19.04.2016
On 1 March, the World Health Organization (WHO) published a new guideline draft on the evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs). This product specific document
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RAPS: FDA Releases Long-Awaited Draft Guidance on Biosimilar Labeling
04.04.2016
The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry
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EMA: Draft concept paper on the revision of the reflection paper on non-clinical and clinical development of similar biological medicinal products containing recombinant interferon alpha or pegylated recombinant interferon alpha
11.01.2016
The current reflection paper on similar medicinal products containing recombinant interferon alpha provides recommendations for the non-clinical and clinical development of recombinant interferon
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GMP: FDA finalizes Guidelines for Biosimilars
21.05.2015
In February 2009, the US Food and Drug Administration has published three draft guidance documents on the development of biosimilars. Now, on 15 April, the FDA issued the finalized version of
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