Guidelines
FDA releases 53 new and revised bioequivalence guidelines for generics
On 12 December 2014, the US Food and Drug Administration (FDA) released 31 new draft guidance documents and 22 revisions to guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients.
Australia reviewing plans for naming biosimilars
Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has changed its plans for naming biosimilars, ‘following recent international developments in the area of biosimilar naming’.
EMA issues revised guideline on non-clinical and clinical issues for biosimilars
On 18 December 2014, the European Medicines Agency (EMA) published the new version of its guideline addressing the non-clinical and clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance. This new guideline will revise the agency’s 2006 overarching guideline on the non-clinical and clinical issues related to similar biological medicinal products.
FDA to carry out survey into affect of generics shape, colour, size
The US Food and Drug Administration (FDA) wants to understand how patients’ perceptions of medications change when pharmacies switch from brand-name to generic drugs or between the same generics made by different manufacturers and how this affects patient adherence to their medication.
China releases draft biosimilars guidance
On 29 October 2014 China’s Center for Drug Evaluation (CDE) published draft guidance for approval of biosimilars.
EMA issues revised version of overarching biosimilars guideline
On 29 October 2014, the European Medicines Agency (EMA) published the new version of its overarching biosimilars guideline, which will revise the agency’s 2005 overarching guideline on similar biological medicinal products.
Concerns from EU and US over Colombian biologicals guidelines
On 21 January 2013, the Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) released a new draft guideline for biologicals, including 'productos bioterapéuticos similares' (similar biotherapeutic products), in Colombia [1]. Since then, both the European Union (EU) and the US have expressed concerns over the draft guidelines.
Generics group calls for say on ICH standards
The generics industry is somewhat annoyed at being excluded from the decision-making process of a global organization, which harmonizes drug quality, safety and efficacy standards.
Generics makers comment on draft ANDA guidance
The quality of abbreviated new drug application (ANDA) submissions could be improved if the US Food and Drug Administration (FDA) spent more time with generics companies before they file an application, according to the Generic Pharmaceutical Association (GPhA).
FDA releases draft guidance on reference product exclusivity for biologicals
The US Food and Drug Administration (FDA) has issued new draft guidance concerning biosimilars. The draft guidance, issued on 5 August 2014, is intended to assist sponsors in determining the date of first licensure for a reference product.
