FDA issues guidance on quality-related considerations for biosimilars

Home/Guidelines | Posted 31/05/2019

The US Food and Drug Administration (FDA) has issued draft biosimilar guidance on quality-related considerations.

The draft guidance was published in a Federal Register announcement published on 22 May 2019. It aims to assist biosimilars developers on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product.

Stakeholders question FDA’s guidance on naming biologicals

Home/Guidelines | Posted 24/05/2019

In March 2019, the US Food and Drug Administration (FDA) issued a new draft guidance document concerning non-proprietary name suffixes for biological products [1]. Many stakeholders comments on the document call for a change in policy from the agency when it comes to naming biologicals.

FDA issues final guidance on interchangeable biologicals

Home/Guidelines | Posted 17/05/2019

The US Food and Drug Administration (FDA) announced on 10 May 2019 that it had issued final guidance on the pathway for interchangeable biologicals.

FDA pledges to improve quality of compounded drugs

Home/Guidelines | Posted 10/05/2019

The US Food and Drug Administration (FDA) released a statement on 3 April 2019 detailing its priorities for improving the quality of compounded drugs in 2019.

Health Canada issues draft guidance on generics labelling and equivalence

Home/Guidelines | Posted 03/05/2019

Canada’s federal department responsible for health, Health Canada, has issued two new draft guidance documents for public consultation as part of the agency’s effort to clarify the eligibility criteria for its abbreviated new drug submission (ANDS) pathway for generics.

FDA proposes update to biosimilar naming guideline

Home/Guidelines | Posted 22/03/2019

The US Food and Drug Administration (FDA) has issued a new draft guidance document concerning non-proprietary name suffixes for biological products.

Brazilian guidelines for follow-on biological products

Home/Guidelines | Posted 08/06/2012

Last update: 15 March 2019

The regulatory body for approval of medicines in Brazil is the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), which was created by Law 9782, enacted in 1999. ANVISA is responsible, under the authority of the Ministry of Health–Mínistério de Saúde–of the Brazilian Government, for drug registration and licences to pharmaceutical laboratories and to other companies inside the pharmaceutical production flow. The agency is also responsible for establishing regulations applicable to clinical trials and drug pricing, which is carried out by the Chamber of Drug Market Regulation.

FDA plans to advance development of complex generics in 2019

Home/Guidelines | Posted 08/03/2019

In a statement released on 30 January 2019, US Food and Drug Administration’s (FDA) Commissioner Scott Gottlieb outlined the steps FDA will take in 2019 to promote access to complex generic medicines.

FDA issues new guidance for accelerated pathway for generics

Home/Guidelines | Posted 22/02/2019

The US Food and Drug Administration (FDA) announced on 15 February 2019 that it had issued new guidance for its novel accelerated pathway for generics – the Competitive Generic Therapies (CGT) pathway.

ICH proposes harmonization of standards for generics

Home/Guidelines | Posted 15/02/2019

As part of its efforts on harmonizing guidelines around the world the International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has released a reflection paper on the scientific and technical standards for generics.