Dive Brief:<\/p>\n
The Food and Drug Administration wants to speed the development of biosimilars, announcing new guidance on Wednesday<\/a> that would no longer require the makers of copycat biologics to run human trials showing their products are as effective and safe as their branded counterparts. Dive Insight:<\/p>\n Biosimilars have yet to achieve their main purpose: to reduce the costs of complex biological drugs, as generics do for small molecules.\u00a0Multiple barriers,\u00a0from development costs to the contracting practices of branded drugmakers, have coalesced to keep prices high and limit uptake. The FDA estimated Wednesday that biosimilars\u2019 market share remains lower than 20%, despite the fact that they\u2019re equivalent to their more expensive counterparts.\u00a0<\/p>\n Among those barriers are the need for clinical studies that test whether there is any meaningful difference between biosimilars and the original drug they\u2019re meant to copy. These studies take one to three years to complete, and cost an average of $24 million, the agency said Wednesday.\u00a0One Phase 3 trial<\/a> of Amgen\u2019s Amjevita, a biosimilar version of the anti-inflammatory medicine Humira, for example, involved 350 patients and tracked the drug\u2019s effects over a year.\u00a0<\/p>\n By comparison, the path to market for generic small molecule drugs is more efficient. They only need to demonstrate<\/a> that they are chemically similar and \u201cbioequivalent<\/a>\u201d to a branded medicine, enabling them to bypass animal and human efficacy studies.<\/p>\n
\nThe FDA agency said the policy shift should make biosimilar development faster and cheaper, estimating that companies could now save $100 million in development costs per product. At a press conference, Commissioner Martin Makary said the move could help create \u201cmore competition [and]\u00a0more choices\u201d for people who need biologic medicines.
\nWednesday\u2019s announcement builds on previous FDA initiatives to ease the development and review of biosimilars. In 2024, the agency proposed dropping studies<\/a> analyzing the effects of \u201cswitching\u201d between branded products and biosimilars. That move was designed to make it easier for biosimilars\u00a0to gain \u201cinterchangeability\u201d status, which allows pharmacists to substitute them for a biologic without a doctor\u2019s prescription.\u00a0<\/p>\n