spacer
home > white papers > Biosimilars In Emerging Markets: Is It A Level Playing Field? - PRA Health Sciences (PRA)
WHITE PAPERS
logo_PRA_Health5.jpg

PRA Health Sciences (PRA)

phone +44 (118) 918-1000
email prahealthsciences@prahs.com
web http://www.prahs.com
email Green Park, 500 South Oak Way, Reading, RG2 6AD UK

Biosimilars In Emerging Markets: Is It A Level Playing Field?

Governments, healthcare payers, and social and health reforms, combined with the increased incidence of conditions such as cancer and diabetes are paving the way for increased uptake of biologic medicines in emerging markets. However, expensive biologic medicines can be prohibitive to many patients, creating a high level of unmet clinical need. At its best, the global expansion of biosimilars can mean a robust and steady supply of existing and new drugs reaching far-flung patient populations, but localized biosimilar drug developments, especially in China and India, combined with a lack of robust pharmacovigilance systems, threaten to derail the industry by putting patient health at risk.
Biosimilars In Emerging Markets: Is It A Level Playing Field?
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

Northway Biotechpharma Celebrates 15 Years of Growth and Success

Vilnius, Lithuania, July 16, 2019 ─ Northway Biotechpharma, a leading biopharmaceutical contract development and manufacturing organization (CDMO), celebrates its 15th anniversary today. As a midsized CDMO, Northway Biotechpharma is able to provide flexibility and responsiveness backed by a strong foundation in science and technology. The company focuses on understanding its customers and meeting their specific needs without binding them to one single approach. It is able to react rapidly to unexpected project changes, adjusting timelines, capacities and other activities to meet its customers’ evolving needs. On average, Northway Biotechpharma has 25–30 development projects underway each year, ranging from gene cloning to final drug product manufacturing.
More info >>


White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
More info >>


Industry Events

ESMO Targeted Anticancer Therapies Congress 2020

2-4 March 2020, Paris, France

A unique and international mix of experts, researchers and decision makers both from academia and industry across the globe, will convene in Paris for a three-day Congress aiming at exchanging knowledge, experience and research innovations in cancer. TAT 2020 will focus, among others, on novel strategies in immuno-oncology, personalised medicine and molecular tumour boards, preclinical studies to identify effective combination therapies, use of microbiome, tumour agnostic trials, ADC technology, oncolytics, multispecific biological constructs and targeting cytokines. Participating in TAT 2020 will offer you the possibility to take part in interdisciplinary discussions inspiring new ideas and new collaborations.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement