Biosimilars: Impact of Biologic Product Life Cycle and European Experience on the Regulatory Trajectory in the United States

摘要: Abstract Background Biosimilars are defined as biologic products that highly similar to reference products, notwithstanding minor differences in clinically inactive components, with no meaningful between the product and terms of safety profile, purity, potency. Due high cost innovator biologics, well an increase number these reaching patent expiry, development a process for approving biosimilar has become crucial regulatory issue United States. Objective This commentary explores relationship structural/biophysical variation risk/benefit profile biosimilars biologics have undergone changes context most recent biophysical, nonclinical, clinical data available. Methods The search strategy used PubMed, EMBASE, MEDLINE retrieval documents pertaining manufacturing, comparative analysis originator relevant review articles on biosimilars. For processes approval biosimilars, generics, legislative decisions, briefing summaries, concept papers, guidance, evaluations approved rejected applications published by World Health Organization, US Food Drug Administration, European Medicines Agency (EMA), other national authorities was conducted. Selected from key opinion leaders manufacturers were also reviewed. These searches conducted provide historical contemporary issues consideration current status worldwide use regulation. Results A total 18 marketing covering 9 programs surveyed. Of these, 14 4 EMA. None reported evidence significant relative compounds absence corresponding biophysical properties. single (Omnitrope ® [somatropin]) both parameters premarketing studies. Biophysical efficacy profiles compared brands noted 2 epoetin products. Conclusions provides EU guidelines resulted therapeutics comparable recommended indications their respective biologics. It is anticipated precedents will serve starting point States efficacious tolerable biotherapeutics advantage health care consumers.