The FDA on Wednes­day pub­lished new draft guid­ance out­lin­ing how biosim­i­lar de­vel­op­ers can cut out Phase 3 com­par­a­tive ef­fi­ca­cy stud­ies, po­ten­tial­ly re­duc­ing de­vel­op­ment time­lines and cut­ting costs.

The move, first dis­closed by FDA Com­mis­sion­er Mar­ty Makary at an As­so­ci­a­tion for Ac­ces­si­ble Med­i­cines con­fer­ence in Mary­land on Wednes­day morn­ing, fol­lows years of work by reg­u­la­tors across mul­ti­ple coun­tries to bring down the bar­ri­ers to mar­ket en­try for biosim­i­lars.

The four-page draft guid­ance says that the agen­cy's think­ing around com­par­a­tive ef­fi­ca­cy stud­ies for biosim­i­lars "has evolved, and FDA has gained sig­nif­i­cant ex­pe­ri­ence in eval­u­at­ing da­ta from com­par­a­tive an­a­lyt­i­cal and clin­i­cal stud­ies used to sup­port a demon­stra­tion of biosim­i­lar­i­ty."

GSK’s in­com­ing CEO Luke Miels said Wednes­day that Medicare ne­go­ti­a­tions for the com­pa­ny’s top-sell­ing res­pi­ra­to­ry prod­uct Trel­e­gy El­lip­ta have con­clud­ed “in line with ex­pec­ta­tions.”

The com­pa­ny is one of the first to dis­close that it has wrapped up the lat­est round of price ne­go­ti­a­tions un­der the In­fla­tion Re­duc­tion Act. Cur­rent CEO Em­ma Walm­s­ley said dur­ing a third-quar­ter earn­ings call that the re­sults for its Trel­e­gy El­lip­ta and Breo El­lip­ta prod­ucts have been “ful­ly fac­tored in­to our out­look.”

Miels’ com­ments of­fer an ear­ly glimpse at how IRA talks with the Trump ad­min­is­tra­tion un­fold­ed. An Astel­las spokesper­son al­so con­firmed to End­points News that ne­go­ti­a­tions have con­clud­ed for its Pfiz­er-part­nered prostate can­cer treat­ment Xtan­di, but the com­pa­ny de­clined to pro­vide fur­ther de­tail.

The US is at risk of los­ing its glob­al lead in biotech.

That was the warn­ing Wednes­day from John Crow­ley, CEO of the Biotech­nol­o­gy In­no­va­tion Or­ga­ni­za­tion — bet­ter known as BIO — dur­ing a sprawl­ing Sen­ate HELP Com­mit­tee hear­ing on how to main­tain the in­dus­try's glob­al com­pet­i­tive­ness.

“We be­lieve with­in two to three years we can lose this,” Crow­ley said.

He lat­er told Sen. Tam­my Bald­win (D-WI) that a world where Chi­na leads in biotech would be “a very dif­fer­ent world from the one we have to­day.”

Chi­na biotech has ex­plod­ed as large West­ern drug­mak­ers strike deal af­ter deal with com­pa­nies there, and small star­tups move ad­vanced ther­a­pies in­to the clin­ic, usu­al­ly be­fore or quite soon af­ter US com­peti­tors — of­ten at a low­er cost. And while sen­a­tors at the hear­ing seemed to grasp the is­sue, there was lit­tle dis­cus­sion or de­bate about what the US might do to main­tain its lead.

Ther­mo Fish­er an­nounced Wednes­day that it will pay $8.9 bil­lion in cash to ac­quire the da­ta so­lu­tions com­pa­ny Clario.

In ad­di­tion to the up­front pay­ment, Ther­mo has agreed to shell out $125 mil­lion in Jan­u­ary 2027, and up to $400 mil­lion in ad­di­tion­al earnouts based on busi­ness per­for­mance over the next two years, mak­ing the to­tal deal worth up to $9.4 bil­lion. Ther­mo will buy Clario from a share­hold­er group led by As­torg and Nordic Cap­i­tal, No­vo Hold­ing and Cin­ven.

Ther­mo CEO Marc Casper said in a news re­lease that Clario’s tech­nol­o­gy, which in­cludes a dig­i­tal end­point plat­form and AI tools, will en­able “faster, more in­formed drug de­vel­op­ment" and "fur­ther ac­cel­er­ate the dig­i­tal trans­for­ma­tion of clin­i­cal re­search.” Clario has 4,000 em­ploy­ees and is ex­pect­ed to gen­er­ate $1.25 bil­lion in 2025 rev­enue.