Guidelines

FDA finalizes biosimilars guidelines

Three years after first issuing draft guidance on biosimilars, the US Food and Drug Administration (FDA) has finally issued three final guidelines for biosimilar applications in the US. The guidances, however, fail to address the issue of interchangeability with reference biologicals, which the agency says it will address in another document.

EMA rejects comparators from outside EEA for insulin biosimilars

The European Medicines Agency (EMA) released its finalized guideline on the non-clinical and clinical development of insulin biosimilars in March 2015 [1]. However, while the guidance took into account many of the comments made by stakeholders on the second draft, the agency rejected requests to accept batches of reference (approved) biological products sourced from outside the European Economic Area (EEA).

FDA guidance on excipients questioned

The International Pharmaceutical Excipient Council of the Americas (IPEC-Americas) has written to the US Food and Drug Administration (FDA) outlining major concerns related to the agency’s guidance on inactive ingredients in abbreviated new drug applications (ANDAs).

EMA issues finalized insulin biosimilars guideline

In March 2015, the European Medicines Agency (EMA) released its finalized guideline on the non-clinical and clinical development of insulin biosimilars.

FDA plans to release four biosimilar guidances during 2015

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to release four new guidance documents on biosimilars during calendar year 2015.

Mexico issues rules on biolimbos

The Mexican regulatory body for approval of medicines, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), has issued rules for older non-originator biologicals registered prior to 19 October 2011, when the country’s guidelines for biocomparables were first published, mandating that companies conduct clinical trials to prove biosimilarity.

FDA calls for comment on generics user fees guidelines

The US Food and Drug Administration (FDA) announced in a Federal register publication of 6 February 2015 the reopening of the docket to solicit public comment on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and the GDUFA Commitment Letter that accompanies the legislation.

FDA calls for comment on biosimilars interchangeability

The US Food and Drug Administration (FDA) wants drugmakers to comment on the information requirements for biosimilars interchangeability.

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.

FDA releases new guidance outlining generics review goals

In July 2014, the US Food and Drug Administration (FDA) issued two new draft guidance documents, which outline the agency’s goals for speeding up its handling of regulatory submissions from generics makers.

EMA issues revised version of biosimilars quality guideline

On 26 June 2014, the European Medicines Agency (EMA) published the new version of its biosimilars quality guideline, which will revise the agency’s 2005 overarching guideline on the quality of similar biological medicinal products. The guideline will come into effect by the end of the year.

Draft guide on monitoring medical literature released for public consultation

On 5 June 2014, the European Medicines Agency (EMA) released a draft guide on the monitoring of medical literature and the entry of relevant information into the EudraVigilance database. The draft guideline has been released for a two-month public consultation period.

Brazil speeds up approval process for generics and biologicals

Brazil’s National Health Surveillance Agency [Agência Nacional de Vigilância Sanitária, ANVISA] announced on 3 June 2014 the publication of a new guideline for generics and biologicals aimed at speeding up the regulatory procedure.

EMA issues draft guideline for insulin biosimilars

On 30 April 2014 the European Medicines Agency (EMA) released a draft guideline on the non-clinical and clinical development of insulin biosimilars. The draft guideline has been released for a three-month consultation period.

FDA releases further biosimilars guidance

The US Food and Drug Administration (FDA) has issued new draft guidance for biosimilars. The draft guideline, issued in May 2014, explains how to use clinical pharmacology data to show biosimilarity to a reference product.

Iranian guidelines for ‘biogenerics’

The regulatory body for approval of medicines in Iran is the Ministry of Health and Medical Education through its Food and Drug Organization (FDO). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Iran.

FDA releases bioequivalence guidance for 26 generics

On 2 April 2014, the US Food and Drug Administration (FDA) released 26 new draft guidance documents on the bioequivalence requirements for the development of generic drugs in question.

Development of Iranian guidelines for ‘biogenerics’

The national regulatory authority for approval of medicines in Iran, the Iranian Food and Drug Organization (FDO), has issued its new guidelines for registration of biologicals (recombinant medicines and monoclonal antibodies) in Iran. The guideline which was published online on 15 March 2014 describes the requirements for registration of both imported and locally manufactured biopharmaceuticals into the Iranian pharmaceutical market.

EMA issues concept paper for revision of immunogenicity guideline

On 25 March 2013 the European Medicines Agency (EMA) announced the publication of a concept paper to discuss the revision of the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. The concept paper has been released for a three-month consultation period.

Nigerian guidelines for biosimilars

Last update:  11 March 2014

The regulatory body for approval of medicines in Nigeria is the National Agency for Food and Drugs Administration and Control (NAFDAC). The agency, through its Regulatory and Registration Directorate, is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Nigeria.

New Zealand guidelines for biosimilars

Last update:  28 February 2014

The regulatory body for approval of medicines in New Zealand is the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). The agency is responsible for the regulation of medicines and medical devices in New Zealand, ensuring that medicines and medical devices are acceptably safe.

Australia to adopt EMA’s monoclonal antibody guideline

The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 14 February 2014 that it was carrying out public consultations on the adoption of European Union guidelines in Australia.

Colombia issues draft decree for registration of biologicals

Last update:  10 January 2014

The Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) announced on 21 January 2013 the release of a new draft guideline for biologicals, including productos bioterapéuticos similares (similar biotherapeutic products), in Colombia.

Venezuela issues draft guideline for bioterapéuticos similares

The Venezuelan Instituto Nacional de Higiene ‘Rafael Rangel’ (INHRR National ‘Rafael Rangel’ Institute of Hygiene) via its National Monitoring Biological Products Division has released a new draft guideline for bioterapéuticos similares (similar biotherapeutics) in Venezuela.

EMA releases product-specific bioequivalence guidelines

The European Medicines Agency (EMA) announced on 15 November 2013 the release of the agency’s first product-specific guidance on the demonstration of bioequivalence for 16 active substances. The draft guidelines have been released for a three-month public consultation period.

EU guidelines for nanosimilars

Last update:  5 November 2013 

The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.

EMA issues draft reflection paper for iron-based nano-colloidal products

On 7 October 2013, the European Medicines Agency (EMA) announced the publication of a draft reflection paper^‡ to discuss the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicine. The draft reflection paper has been released for a five-month consultation period.

FDA publishes guidance on ANDAs for new strengths

The US Food and Drug Administration (FDA) has published draft guidance for industry for abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) where the applicant is seeking approval of a new strength of the drug product.

EMA organizes workshop on biosimilars guidelines

The European Medicines Agency (EMA) announced on 25 September 2013 that the agency would be organizing a workshop on biosimilars.

EMA issues draft concept paper on comparing quality in biologicals and biosimilars

On 28 June 2013, the European Medicines Agency (EMA) released a draft concept paper to discuss the issue of how to compare the quality attributes for biological products and biosimilars. The draft concept paper has been released for a three-month consultation period.

Revision of guideline on clinical and non-clinical issues for biosimilars

On 10 June 2013, EMA released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance. The draft guideline has been released for a six-month consultation period.