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The regulatory evolution of biosimilars is still relatively immature. The EMA published the world's first biosimilar guidelines in 2005, with the FDA publishing its guidelines in 2012. The convergence between these and other regulatory guidelines has been slow, preventing single cost‐effective biosimilar development. Biosimilar legislation is only in its infancy. The Hatch‐Waxman Act in the United States in 1984 did not lead to an immediate mature small molecule drug generic market, and neither will this be the case for biosimilars. As regulatory agencies and biosimilar manufacturers gain experience in bringing biosimilars to market, regulatory difficulties and pathways will have a smaller impact on biosimilar uptake.

Players have gained experience developing and taking biosimilars through regulatory procedures. This combined with a greater understanding of the biosimilar business model has meant that biosimilars are now being developed earlier and with greater competition than was the case previously. Moving forward, the lag time between biologic loss of patent protection and biosimilar launch will decrease.²²