EMEA: Overview of comments received on draft guideline on similar biological medicinal products containing low-molecular-weight-heparins

The guidance is limited to non-clinical and clinical aspects and does not address the Quality Standard aspects that biosimilar products must adhere to. This may be misunderstood as “the quality comparability exercise between the biosimilar and the reference LMWHs can be overlooked as long as a non-clinical and clinical comparative program is undertaken”.