The EMA received in 2016 the highest number of initial applications for biosimilars

The EMA received in 2016 the highest number of initial applications for biosimilars

The initial
evaluation includes all activities relating to the processing of
marketing-authorization applications (MAA) for new medicines which have never
been assessed before. It covers from the pre-submission discussion with future
applicants, through evaluation by the CHMP, to the granting of a marketing
authorization by the European Commission.

An upward
trend is being observed over the last five years. In 2013, 80 applications for
medicinal products were received, while in 2016 it reached 114 applications.

Especial
increase has been detected in biosimilar products achieving in 2016 the highest
number of applications in a year so far with 14 new applications.

Asphalion
would like to highlight this record as we are currently working in many
biosimilar projects. We have large experience in biosimilar’s Scientific
Advice, dossier preparation, due diligence, RMP, publishing, assistance during
product development and many more services.

We also
have experience in FDA biosimilar projects such as BLA, IND meeting and
publishing.

If you have
a biosimilar project we can help you on regulatory requirements in EMA and FDA.
Contact us at
info@asphalion.com and get more information!

Free Webinar! Data extraction from SmPCs into structured data for ISO IDMP compliance
New Medical Devices Regulations Implementation Plan

Leave a Reply