Improvements in technology and pressures to diversify business models away from small molecule drugs are just two of the factors that are focussing
The Indian Ministries of Health & Family Welfare and Science and Technology have released their Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India (the “Indian Guidelines”).
The Food and Drug Administration (FDA) releases a final guide dated February 2012 titled “Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information.”
Biological productsa category that includes proteins, such as antibodies, vaccines, blood products, and serumsare becoming increasingly important in the treatment of disease.
The EMA’s initial guidance on biosimilarity, the so-called “overarching guidelines,” adopted in 2005, introduced the general approach for development and approval of biosimilar products.
In this article, we examine the issues surrounding the regulation of biosimilar drugs in Australia, including pricing issues under the Pharmaceutical Benefits Scheme.
The Food and Drug Administration (FDA) recently conducted a two-day hearing to begin the process of determining how it will go about creating review standards for the generic copies (biosimilars) of prescription drugs developed from biological materials (biologics).
The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law), establishes an abbreviated licensure pathway for biosimilar biological products, with provisions covering exclusivity periods, and payment for biosimilars.
Reps. Waxman, Frank Pallone (D-N.J.), Nathan Deal (R-Ga.) and Jo Ann Emerson (R-Mo.) introduced a bipartisan bill (H.R. 1427, the "Promoting Innovation and Access to Life-Saving Medicine Act") that would give the Food and Drug Administration (FDA) authority to approve generic versions of biological drug products.
A bill that would allow the Food and Drug Administration (FDA) to approve similar versions of already-approved biologic drugs was introduced on March 11, 2009, by House Energy and Commerce Committee Chairman Henry Waxman (D-Calif.), and Reps. Frank Pallone (D-N.J.), Nathan Deal (R-Ga.), and Jo Ann Emerson (R-Mo.).