EMA rejigs biosimilar guidelines to help developers avoid repeating trials

By Gareth Macdonald

- Last updated on GMT

EMA publishes innovative guidelines for biosimilar developers
EMA publishes innovative guidelines for biosimilar developers

Related tags European medicines agency European union Food and drug administration

Reference drugs in biosimilar trials now only need to be “representative” of a product cleared in the EEA not approved themselves under guidelines issued by the EMA this week. 

The ruling – detailed in guidance issued by the European Medicines Agency (EMA) this week – is designed to help developers avoid repeating costly early phase research and clinical trials.

The main caveat is that “it will be the Applicant's responsibility to demonstrate that the comparator authorised outside the EEA [European Economic Area] is representative of the reference product authorised in the EEA.​”

This will involve proving the non-EEA drug is of comparable quality which means “side-by-side analysis of the biosimilar product, from commercial scale and site, with EEA authorised reference product must be conducted” according to the Agency.

Additionally, filers using non-EEA approved comparators for preclinical research and human trials must justify their choice, which the EMA said will likely require structural and functional tests on all three drugs as well as bridging PK and PD studies.

The overall acceptability of such an approach and the type of bridging data needed will be a case-by-case and/or product-type decision, and is recommended to be discussed upfront with the Regulatory Authorities.

However, the final determination of the adequacy of the scientific justification and bridge will only be made during the assessment of the application​.”

Biosimilars a global business

The EMA first mooted the 'bridging data' idea in draft biosimilars guidance issue in 2012, just three months after the then European Commissioner for Health and Consumer Policy, John Dalli, emphasised the global nature of the biosimilars sector​.

“The development of biosimilars has become an increasingly global business. I realise however that the application of the EU rules do not fully match this trend.” 

The inclusion of the bridging data principle in the new guidelines was welcomed the European Generic medicines Association (EGA), which said it “constitutes an important step forward in facilitating the global development of biosimilar medicines while avoiding unnecessary repetition of clinical trials​.”

The EMA has already approved 19 biosimilar products including several monoclonal antibodies, the first of which was clear in July 2013​, as is seen by many in the industry as one of the most progressive and influential regulators.

Speaking to BioPharma-Reporter.com in October, Daniel Galbraith from UK-based contractor BioOutsource said: “The EMA is still seen as the most forward thinking agency" ​adding that “the Korean and Asian markets, especially the Indian market have used the EMA guideline as a blueprint for their own.

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