Search Results for biosimilar guidance

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FDA Offers Draft Guidance on Statistical Approaches to Evaluating Similarity for Biosimilars By Zachary Brennan - Published 21 September 2017

The US Food and Drug Administration (FDA) on Thursday released another piece of the biosimilars puzzle for industry, offering new draft guidance on the type of information a sponsor should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan and the statistical approaches recommended for evaluating analytical similarity.

Categories: News, US, FDA, Biologics and biotechnology, Regulatory intelligence, Regulatory strategy

Tags: biosimilar guidance, analytical similarity, FDA guidance

Biopharma Companies Take Issue With FDA's Draft Biosimilar Interchangeability Guidance By Zachary Brennan - Published 18 May 2017

Ahead of Friday's deadline for comments, a number of biopharmaceutical companies are seeking further clarification from the US Food and Drug Administration (FDA) on various aspects of the draft biosimilar interchangeability guidance.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Labeling, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: biosimilars, interchangeability, FDA draft guidance, biosimilar guidance

Asia Regulatory Roundup: India Revises Draft Biosimilar Guidance (5 July 2016) By Nick Paul Taylor - Published 05 July 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Due Diligence

Tags: Asia Regulatory Roundup, biosimilar guidance

India Releases New Biosimilars Guidance By Zachary Brennan - Published 28 March 2016

India’s Central Drugs Standard Control Organization (CDSCO) on Saturday released new guidance for biosimilar developers as new biosimilars come to market there before other regions, and as India's regulators look to develop more specific guidance on postmarketing studies.

Categories: News, India, Korea, CDSCO, Biologics and biotechnology, Clinical, Government affairs, Manufacturing, Postmarket surveillance

Tags: biosimilars, biosimilar guidance, CDSCO guidance, India biosimilars, Herceptin

FDA’s CDER Unveils Plans for 2016 Guidance Documents By Zachary Brennan - Published 22 January 2016

The guidance agenda for the next fiscal year from the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) reveals a lot of new advice on generics, pharmaceutical quality, off-label communications and other recommendations carried over from 2015, particularly on the implementation of the Drug Supply Chain Security Act (DSCSA).

Categories: News, US, CDER, Advertising and Promotion, Clinical, Drugs, Due Diligence, Labeling, Manufacturing, Postmarket surveillance, Preclinical, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: CDER guidance, 2016 guidance documents, biosimilar guidance

FDA Publishes New Guidance on Common Biosimilarity Questions By Alexander Gaffney, RAC - Published 12 May 2015

A newly revised guidance document published by the US Food and Drug Administration (FDA) provides additional insight into how the agency plans to regulate biosimilar products.

Categories: News, US, CDER, Biologics and biotechnology

Tags: Biosimilar, Guidance, Final Guidance, Biosimilarity

FDA's Latest Biosimilars Guidance: How to Show Biosimilarity Using Pharmacological Testing By Alexander Gaffney, RAC - Published 13 May 2014

Categories: US, FDA

Tags: Biosimilar Guidance, Biosimilarity, PD, PK, Pharmacology, Latest News, biosimilar, draft guidance

New FDA Guidance Tries to Define When Antibody Products are 'The Same' By Alexander Gaffney, RAC - Published 23 April 2014

Categories: US, FDA

Tags: Market Exclusivity, Sameness, Same, ODA, Biosimilarity, Orphan Drug Act, Latest News, BPCI, biosimilar, guidance

US Biosimilar Guidelines: Summary and Insights By Kamali Chance, MPH, PhD, RAC - Published 03 April 2012

In March 2010, section 351(a) of the Public Health Service Act was amended to create an abbreviated pathway for the approval of biosimilars or interchangeable biologic products that were found to be highly similar to US Food and Drug Administration (FDA) licensed biologics. This article explores recent FDA guidance pertaining to biosimilar products.

Categories: Features, FDA

Tags: Biosimilarity, Biogenerics, biosimilar, guidance, Biosimilars, Follow-on Biologics, Biologics