BETHES­DA, MD — The FDA's top biosim­i­lars ex­pert Sarah Yim said the agency is look­ing to take "a lit­tle less" of an "al­go­rith­mic ap­proach" to re­view­ing ap­pli­ca­tions, with the goal of ac­cel­er­at­ing the de­vel­op­ment of the prod­ucts to look more like gener­ic small-mol­e­cule drugs.

Speak­ing at the As­so­ci­a­tion of Ac­ces­si­ble Med­i­ci­nes' GRx+Biosims con­fer­ence on Tues­day, Yim said that "we're re­al­ly try­ing to stream­line biosim­i­lar de­vel­op­ment, make it more ef­fi­cient, both in terms of tim­ing and mon­e­tary re­sources for de­vel­op­ers."

Yim is the di­rec­tor of FDA's Of­fice of Ther­a­peu­tic Bi­o­log­ics and Biosim­i­lars, and said she's "very aware" of an IQVIA re­port from Feb­ru­ary that found dozens of bi­o­log­ics are los­ing patent pro­tec­tion over the next decade and that the ma­jor­i­ty may see no biosim­i­lar com­pe­ti­tion be­cause the pipeline is­n't there.

De­spite re­cent set­backs in court, Eli Lil­ly is dou­bling down on its fight against com­pound­ed weight loss drugs.

The phar­ma gi­ant told End­points News on Tues­day that it plans to re­file its com­plaint against the tele­health com­pa­ny Mochi Health af­ter a Cal­i­for­nia fed­er­al judge dis­missed the case on Fri­day for lack of stand­ing. Lil­ly al­so filed two new law­suits last week against Texas com­pound­ing phar­ma­cies, bring­ing the to­tal num­ber of cas­es filed against com­pounders, tele­health com­pa­nies and med spas to 34.

“We con­tin­ue to find se­ri­ous safe­ty risks in com­pound­ed prod­ucts. Pa­tients de­serve re­al med­i­cine they can trust, and we urge FDA and oth­er reg­u­la­tors to stop mass com­pound­ing,” a Lil­ly spokesper­son told End­points on Tues­day.

The im­pact of phar­ma’s di­rect-to-pa­tient ef­forts is get­ting clear­er.

When Lil­ly launched its Lil­ly­Di­rect pro­gram in Jan­u­ary 2024, it wasn’t im­me­di­ate­ly clear how big the busi­ness would be. And for a while, the busi­ness on­ly made up a “low sin­gle-dig­it” per­cent­age of over­all Lil­ly pre­scrip­tions.

That’s start­ing to change. As of the sec­ond quar­ter of 2025, Lil­ly­Di­rect, in­clud­ing sales that come from cash-pay­ing pa­tients, makes up 35% of new pre­scrip­tions of Zep­bound, Jen­nifer Mazur, SVP, Lil­ly USA Con­sumer Ser­vices and Lil­ly­Di­rect told End­points News.

The in­flec­tion point came when Lil­ly launched self-pay prices in Au­gust 2024 for vials of tirzepatide, mar­ket­ed as Zep­bound for weight loss. That let it of­fer the med­ica­tion be­low its list price to com­pete with cheap­er al­ter­na­tives from com­pound­ing phar­ma­cies that had grown in pop­u­lar­i­ty while Zep­bound was in short­age un­til De­cem­ber 2024.

Delix has ear­ly-stage clin­i­cal da­ta show­ing that its non-hal­lu­cino­genic neu­ro­plas­to­gen could be a fu­ture de­pres­sion treat­ment op­tion. It al­so said the FDA cleared at-home use of its can­di­date in a fu­ture Phase 2 study.

The biotech re­port­ed Tues­day that zal­supin­dole pro­duced en­cour­ag­ing bio­mark­er and clin­i­cal da­ta in 18 pa­tients with ma­jor de­pres­sive dis­or­der en­rolled in a Phase 1b study. Pa­tients were ran­dom­ized in­to two co­horts, one that re­ceived a sin­gle dose of the oral can­di­date for sev­en con­sec­u­tive days and an­oth­er giv­en zal­supin­dole two days in the first week of the tri­al.

Pa­tients record­ed an 11.6 mean re­duc­tion in the Mont­gomery-Ås­berg De­pres­sion Rat­ing Scale, a mea­sure­ment of de­pres­sion symp­toms, by week eight, cor­re­spond­ing to a 50% im­prove­ment in symp­toms. Delix says that the symp­tom im­prove­ments were main­tained through day 36, four weeks af­ter the last dose. No se­ri­ous ad­verse events or “hal­lu­ci­na­to­ry, dis­so­cia­tive or psy­chotomimet­ic ef­fects were re­port­ed.”