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, 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."

A stream­lined ap­proach can be used when the bi­o­log­ic and pro­posed biosim­i­lar are made from clon­al cell lines, when the qual­i­ty at­trib­ut­es are un­der­stood for the ref­er­ence bi­o­log­ic, and when phar­ma­co­ki­net­ic stud­ies are fea­si­ble and clin­i­cal­ly rel­e­vant, the draft says.

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 for 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.

The FDA last week tran­si­tioned Mary Thanh Hai from act­ing to per­ma­nent di­rec­tor of the Of­fice of New Drugs, two peo­ple with knowl­edge of the move told End­points News.

Thanh Hai took over as act­ing OND di­rec­tor from Pe­ter Stein, who was pushed out of his po­si­tion in April as part of a wider re­duc­tion in force. OND is re­spon­si­ble for ap­prov­ing all new drugs.

Stein told End­points on Mon­day that he thought Thanh Hai was "a great choice — she’s high­ly ex­pe­ri­enced, an­a­lyt­ic and thor­ough, ex­treme­ly knowl­edge­able."

The FDA, CDER Di­rec­tor George Tid­marsh, and Thanh Hai did not im­me­di­ate­ly re­spond to re­quests for com­ment.

The FDA sent an un­usu­al in­spec­tion re­port late last month to the In­di­an gener­ic drug­mak­er Het­ero Labs af­ter un­cov­er­ing an unau­tho­rized ware­house hold­ing drugs and ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (APIs) that was al­so in­fest­ed with lizards, birds and cats.

Ac­cord­ing to the Form 483, re­leased Fri­day, FDA in­spec­tors ar­rived at Het­ero's Visakha­p­at­nam, In­dia-based ware­house in late Sep­tem­ber and were de­nied en­try for ap­prox­i­mate­ly two hours.

The ware­house holds key start­ing ma­te­ri­als, in­clud­ing "in­ter­me­di­ates and fin­ished APIs for US FDA reg­is­tered man­u­fac­tur­ing fa­cil­i­ties that rou­tine­ly dis­trib­ute to the US mar­ket and to fa­cil­i­ties that man­u­fac­ture fin­ished drug prod­ucts for the US."

Staff at the site "ran out of plain sight" when the FDA in­spec­tors an­nounced their in­tent to in­spect the fa­cil­i­ty. When they fi­nal­ly did get in­to the ware­house, they un­cov­ered nu­mer­ous is­sues, even as the com­pa­ny em­ploy­ees claimed the ware­house is on­ly for dis­tri­b­u­tion to the do­mes­tic In­di­an drug mar­ket.

The FDA has ap­proved Bay­er’s treat­ment for hot flash­es caused by menopause, bol­ster­ing the com­pa­ny’s women’s health port­fo­lio.

Bay­er said Fri­day that Lynkuet is the first dual neu­rokinin-tar­get­ed ther­a­py to win FDA ap­proval. The de­ci­sion was based on three Phase 3 stud­ies that showed the once-dai­ly pill re­duced the fre­quen­cy and sever­i­ty of mod­er­ate to se­vere hot flash­es. It is ex­pect­ed to be­come avail­able in the US next month.

The FDA need­ed ad­di­tion­al time to make its de­ci­sion, ex­tend­ing the re­view of Lynkuet in Ju­ly. The drug is al­so ap­proved in the UK, Aus­tralia, Switzer­land and Cana­da.

Lynkuet is the lat­est prod­uct to join Bay­er’s port­fo­lio of women’s health-fo­cused drugs and de­vices. The Ger­man phar­ma­ceu­ti­cal mak­er al­so sells con­tra­cep­tives and a treat­ment for pelvic pain re­lat­ed to en­dometrio­sis.