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For authorized biosimilars to achieve full acceptance in the marketplace, it is crucial that they are considered to be therapeutically equivalent and interchangeable with the brand reference product.
Accounting for errors arising from different high-throughput sequencing platforms and those arising from the approaches used to call variants are at the center of a controversy in RNA editing.
Sales in the biologics sector show modest but healthy growth rates for the fourth consecutive year, with cancer drugs garnering the greatest revenues. As the diabetes epidemic grows and innovation of insulins continues, drug companies in that space are moving up in the ranks.
With the first marketing authorization application for a biosimilar monoclonal antibody now under consideration at the European Medicines Agency, what are the critical issues for regulators?