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China publishes draft guideline for denosumab copy biologicals

Another specific guidance for makers of copy biologicals has been published by China’s Center for Drug Evaluation (CDE). This time the guidance covers denosumab.

China publishes draft guideline for trastuzumab copy biologicals

China’s Center for Drug Evaluation (CDE) has published yet more specific guidance for makers of copy biologicals in the country, this time for trastuzumab.

China publishes draft guideline for bevacizumab copy biologicals

On 7 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of bevacizumab copy biologicals. This guidance is the second specific guideline released by the CDE in April. The agency also released guidance on adalimumab on 1 April 2020 [1].

FDA issues guidance on hydroxychloroquine, chloroquine

The US Food and Drug Administration (FDA) has released new guidance on hydroxychloroquine and chloroquine, which have been raised by President Trump as treatments for coronavirus, despite limited evidence.

China publishes draft guideline for adalimumab copy biologicals

On 1 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of adalimumab copy biologicals.

Guidelines released on USAN naming

The American Medical Association (AMA) has issued guidelines on naming using United States Adopted Names (USAN), which are unique non-proprietary names assigned to pharmaceuticals sold in the US.

FDA opens pathway to biosimilar insulin products

On 23 March 2020, insulin products in the US transitioned to a new regulatory pathway which will allow biosimilars to be developed. The change should make insulin products more affordable for American citizens.

FDA to transition NDAs to BLAs

The US Food and Drug Administration (FDA) is soon to transition many new drug applications (NDAs) to biologicals license applications (BLAs), with significant implications for biotechnology companies and drug compounders.

Comments criticize FDA guidance on insulin biosimilars

Eli Lilly and Novo Nordisk have submitted critical comments on the US Food and Drug Administration’s (FDA) draft guidance on insulin biosimilars, which suggests that immunogenicity testing may not be necessary for all products.

FDA issues new rule on definition of term ‘biological product’

The US Food and Drug Administration (FDA) announced on 20 February 2020 that it had issued a final rule on the definition of the term ‘biological product’.