Major Guideline on Biosimilars finalized BY EMA

The guideline takes into account four important aspects of biosimilars-safety, efficacy, quality and biological activity. Each biosimilar product will have to be evaluated based on analytical methods, clinical comparability models and manufacturing processes used to create and validate the biosimilar product. Products thoroughly characterized and proven similar to the reference product will be benefitted from this guideline. Medicine need to be administered in same way as the innovator but small changes small changes in the product’s strength, form, formulation and use of excipients would be acceptable so long as they could be justified using data and did not “compromise safety.” The guideline takes into account four important aspects of biosimilars-safety, efficacy, quality and biological activity. Each biosimilar product will have to be evaluated based on analytical methods, clinical comparability models and manufacturing processes used to create and validate the biosimilar product. Products thoroughly characterized and proven similar to the reference product will be benefitted from this guideline. Medicine need to be administered in same way as the innovator but small changes small changes in the product’s strength, form, formulation and use of excipients would be acceptable so long as they could be justified using data and did not “compromise safety.”

The guideline has introduced a step wise approach leading to generation of data at every stage of the evaluation process giving more clarity regarding the principles of establishing biosimilarity. As per EMA if the biosimilar comparability exercise indicates that there are relevant differences between the intended biosimilar and the reference medicinal product making it unlikely that biosimilarity will eventually be established, a stand-alone development to support a full Marketing Authorisation Application (MAA) should be considered.

The guidelines biggest information is the bridging data which states that companies have to show that the product approved outside European Economic Area (EEA) is the representative of the reference product authorized in the EEA and the justification would include data from analytical studies that compare the biosimilar, the EEA-approved product and the non-EEA-approved product, and may also include pharmacokinetic and pharmacologic data as well. IGMPI