[Ip-health] webinar Feb 14 - Regulation to accelerate access to biosimilars: Colombia's pioneering approach

marcela vieira marcelacfvieira at gmail.com
Tue Feb 5 22:19:48 PST 2019


Dear ip-health readers,

We are pleased to invite you to the next webinar organized by the Knowledge
Network on Innovation and Access to Medicines, presenting recent research
on topics relating to pharmaceuticals policy.

Regulation to accelerate access to biosimilars: Colombia's pioneering
approach


Thursday 14 February | 4:00pm-5:00pm CET

Speaker:

Carolina Gomez, advisor for the General Directorate, INVIMA - Instituto
Nacional de Vigilancia de Medicamentos y Alimentos (National Institute of
Food and Drug Monitoring), Colombia



Paper:

Barreras técnicas innecesarias a la competencia y la inequidad en el
acceso: el caso de los  medicamentos biotecnológicos
<http://bit.ly/CVCGbiosimilars>(forthcoming)

The debate on regulating biotechnology drugs: Colombia in the international
context <http://iris.paho.org/xmlui/handle/123456789/28578> (2016)


To join the webinar on Thursday 14 February, please register here
<https://zoom.us/webinar/register/6115494299225/WN_dH5_IX-aRrqMMTFgWH62Yg>.



Background

An increasing number of biological medicines are being developed and used
to treat a wide range of health conditions, such as cancers, diabetes,
autoimmune diseases. Many challenges impede wider use of these technologies
by patients and national health systems, including their high prices. Out
of the 10 most sold medicines in 2017, 7 are biologics. Complexities in the
development, production and regulatory framework for biologics can limit
competition, contributing to keeping prices out of reach for many. With
patent protection and data exclusivity for a number of biologics medicines
expiring, how can regulations assure quality, safety and efficacy, without
becoming a technical barrier to competition? How can regulation accelerate
access?



Carolina Gomez will present the regulation Colombia adopted in 2014 for the
evaluation of biologics, with a special focus on the process to authorize
competing products -- i.e. biosimilars or biogenerics. She will explain the
‘fast-track’ approach used to accelerate access by reducing unnecessary
regulatory requirements, as detailed in her 2016 article (above). She will
also identify the main technical barriers in the international regulation
of biologics (e.g. clinical comparability, differential nomenclature and
restriction of substitution and interchangeability) explored in her
forthcoming paper (above). Finally, she will discuss how the regulation
adopted in Colombia can inform ongoing international debates, including the
evolution of WHO guidance on biologics regulation.



Who should consider attending?

Those interested in learning more about:

- Measures to address high prices of biological medicines

- Regulatory framework for market approval of biologics

- Regulatory approaches to accelerate competition and access to biosimilars



The webinar is free and will be held in English. Participants will be able
to pose questions orally and in writing during the webinar, and the speaker
will respond to a selection of these during the second half of the event.
Recordings of all webinars will be made available online at the Global
Health Centre webpage
<http://graduateinstitute.ch/home/research/centresandprogrammes/globalhealth/research/webinars-1.html>.
After registering, you will receive a confirmation email with additional
information on how to join the webinar.

We hope you will be able to join us for this informative presentation. This
event is part of the webinar series of the Knowledge Network for Innovation
and Access to Medicines, a project of the Global Health Centre at the
Graduate Institute of Geneva. Suggestions for speakers and topics for
future webinars are welcome at globalhealthresearch at graduateinstitute.ch.


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