EMA Guideline on similar Biological Medicinal Products adopted

New Drug Approvals

EMA Guideline on similar Biological Medicinal Products adopted
On 23 October, the CHMP adopted the revised Guideline on similar biological medicinal products. Get more details here.


Last year the “Draft Guideline on Similar Biological Medicinal Products” was published by EMA.

After agreement of the revised draft by the Biosimilar Medicinal Products Working Party and Biologics Working Party in July, the CHMP adopted and published the final Guideline on 23 October 2014. They summarized the outline of the document as follows:

“This Guideline outlines the general principles to be applied for similar biological medicinal products (also known as biosimilars) as referred to in Directive 2001/83/EC, as amended, where it is stated that ‘the general principles to be applied [for similar biological medicinal products] are addressed in a guideline taking into account the characteristics of the concerned biological medicinal product published by the Agency’.
This Guideline describes and addresses the…

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New USP Requirements on Plastic Packaging Systems

New USP Requirements on Plastic Packaging Systems

The USP describes in an article of the Pharmacopeial Forum the future requirements for plastic packaging systems. Here, the importance is laid on the selection of suitable, safe plastic materials and the verification of potential interactions. More information can be found here in the News.

GMP News: New USP Requirements on Plastic Packaging Systems

An interesting article from the USP on the future requirements for plastic packaging systems has been published in the Pharmacopoeial Forum 39(6).

In this article, the USP’s experts group provides an overview of the already existing and also the planned General Chapters on pharmaceutical plastic packaging systems. Together both chapters aim to describe a general and chemistry-based approach for the quality and safety of packaging systems and their starting materials for the construction of these packaging systems.

Among the key topics which are discussed, you can find:

  • a. The selection of suitable, safe plastic materials of construction
  • b. The importance of characterizing both the materials of construction and the packaging system
  • c. Extractables and leachables

Interactions between the product and the packaging system which may influence the quality of the product are of significance. Such interactions can be additive, reductive or transformative. In case of additive interactions, a constituent of the packaging system is added to the product; if reductive, a product constituent is reduced – for example due to its uptake into the packaging system. Transformative interactions may lead to a loss of stability for example because of physicochemical interactions.

The two new chapters:

  • <661.1> – Plastic Packaging Systems and their Materials of Construction, and
  • <661.2> – Plastic Packaging Systems for Pharmaceutical Use

should also be clearly delimited against elastomeric closures, containers made of glass and containers made of metal which have their own General Chapters.

You will find more information on the USP Pharmacopeial Forum (PF) website.

Glenmark’s Enrollment Begins of First Patient in Phase II Vatelizumab (GBR 500) Trial in Relapsing Remitting Multiple Sclerosis

New Drug Approvals

Enrollment Begins of First Patient in Phase II Vatelizumab Trial in Relapsing Remitting Multiple Sclerosis 

Glenmark outlicensed Vatelizumab (GBR 500) to Sanofi for all indications in 2011

Mumbai – India, November 4, 2014: Glenmark announced today enrollment of the first patient in a multicenter Phase II clinical trial to evaluate Genzyme’s investigational infusion therapy vatelizumab in patients with relapsing remitting multiple sclerosis (RRMS). The trial, called EMPIRE, is designed to assess the efficacy of vatelizumab vs. placebo in RRMS patients. The safety, tolerability and pharmacokinetics of vatelizumab will also be assessed.

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The mechanism of action of vatelizumab, which is developed in a collaboration between Glenmark Pharmaceuticals and Genzyme, is not yet fully understood. However, the researchers believe that it will be able to block VLA-2 on activated immune cells, which may enable the interference with collagen-binding in areas of inflammation, as well as leading to the…

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