|
|
|
European Biopharmaceutical Review
|
| While the European Union is leading the way in bringing similar biological medicinal products, or ‘biosimilars’, to patients in need, activity in the past year signals a greater push in the US on this front, claims Suzanne Sensabaugh at MDS Pharma Services
The US Food and Drug Administration (FDA) has demonstrated its willingness to work with Congress to establish a pathway for follow-on protein products (FOPPs) – the term the US has selected for biosimilar products. Also in the budget for the fiscal year 2009, US President George Bush has proposed that the FDA be given the authority to establish this pathway (1). Considering these recent events, now is a relevant time to reflect on how biosimilars came to the market in the EU, what we have learned in the development of these drugs, and the current situation in the US. BIOSIMILARS IN THE EU
Sustainability of national healthcare systems and the need for competition in the field of biotechnology-derived medicines were strong drivers of the establishment of the legal pathway for biosimilars in the EU (2). In 2003, the requirements for biosimilars were placed in the section of the law reserved for abbreviated applications. In 2004, legislation was enacted clarifying that results of testing related to safety (preclinical) or to efficacy (clinical), or indeed both, were required for approval. During the European Medicines Agency’s (EMEA) normal course of business of reviewing confidential data and making decisions on biosimilar dossiers, they obtained the necessary information to draft guidance documents. The guidance documents described the basic principles and concepts of similar biological medicinal products. Productspecific guidelines were also drafted which detailed nonclinical and clinical requirements for recombinant Erythropoetin (EPO), Somatropin (human growth hormone), Granulocyte-Colony Stimulating Factor (G-CSF), and Insulin. |
Read full article from PDF >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
Suzanne M Sensabaugh is VP, Biopharmaceutical Development, MDS Pharma Services, where
she is responsible for managing and directing the consulting group in Development & Regulatory
Services and providing professional guidance to clients. Prior to this position, she was VP,
Regulatory Affairs, and Senior Director for Global Biogenerics, Teva Pharmaceutical Industries Ltd,
where she developed regulatory strategy and submissions for biotechnology products. She has
more than 10 years of experience at the FDA/CBER as a researcher, product reviewer and inspector
for biologics. She has additional experience in the industry as Associate Director, Regulatory
Affairs, Genzyme Corporation, and as VP, RA and Quality at the Biotechnology Division of SICOR Inc.
She also teaches clinical development at Johns Hopkins University. She received her MBA from
Duke University, MS in Biotechnology from Johns Hopkins University, and BS in Zoology from the
University of Maryland |
|
|
|
|
|
 |
Industry Events |
 |
5th Annual BioPharma Asia Convention 2012
19-22 March 2012, Marina Bay Sands, Singapore
BioPharma Asia Convention is the only event that brings together senior level executives from global and regional pharma companies, biotechs, CMOs, CROs, academic institutions, investors and all other industrial stakeholders to assess the latest industrial trends, partnership models and solutions in Asia.
More info >> |
|
 |
News and Press Releases |
 |
The Marketing Machine Helps International Pharma Client with Ambitious Literacy Drug Packaging Rebrand
Full-service advertising and branding firm The Marketing Machine recently finished an ambitious, innovative rebranding project for Danadams Pharmaceuticals Industry Limited to help overcome literacy and distribution challenges with patients in Ghana, South Africa. The firm utilized its award-winning design services team to redesign all of Danadams branding and packaging using intuitive visual icons and color elements to indicate the type of drugs and dosages and better display information more clearly and legibly. Danadams Pharmaceuticals is currently the only manufacturer of anti-retroviral drugs in West Africa. It also manufactures and sells anti-malarials, antibiotics, analgesics and other opportunistic infection drugs for the West African market.
More info >> |
|
|
