Brook­ings is­sues rec­om­men­da­tions for gener­ic drug com­pe­ti­tion as PDU­FA VI ex­pi­ra­tion looms

While the FDA, in­dus­try in­sid­ers and politi­cians have all weighed in on what the newest it­er­a­tion of PDU­FA should look like, a new re­port from a pri­vate re­search group out­lines an op­por­tu­ni­ty to change some of the FDA’s au­thor­i­ty to pro­mote gener­ic en­try.

The Brook­ings In­sti­tu­tion’s Rachel Sachs, Mar­ta Wosińs­ka, Richard G. Frank, and Loren Adler part­nered with USC’s Leonard D. Schaf­fer Cen­ter for Health Pol­i­cy & Eco­nom­ics to au­thor a pa­per pub­lished Tues­day to ad­dress some con­cerns with­in FDA’s cur­rent reg­u­la­to­ry process­es. They specif­i­cal­ly re­fined three mea­sures to pro­mote bet­ter gener­ic drug com­pe­ti­tion: the Cit­i­zen Pe­ti­tion mech­a­nism; the ap­proval of “com­plex gener­ic drugs;” and gener­ic drug “park­ing” un­der the Hatch-Wax­man Act.

Cit­i­zen pe­ti­tions, in which the FDA al­lows pe­ti­tion­ers to ask the agency to ei­ther re­ject or de­lay new drugs on grounds that re­view is “nec­es­sary to pro­tect the pub­lic health,” can be use­ful, ac­cord­ing to the au­thors. How­ev­er, the au­thors said that ev­i­dence sug­gests not-so-be­nign mo­tives.

Ev­i­dence sug­gests that in­ter­est­ed par­ties (who are large­ly, though not ex­clu­sive­ly, brand­ed phar­ma­ceu­ti­cal firms fac­ing the loss of mar­ket ex­clu­siv­i­ty) are of­ten fil­ing cit­i­zen pe­ti­tions that have the ef­fect of de­lay­ing gener­ic or biosim­i­lar en­try to de­fer com­pe­ti­tion and main­tain their ex­ist­ing mar­ket po­si­tion.

Their pro­posed so­lu­tions? “Strength­en the FDA’s au­thor­i­ty to dis­miss pe­ti­tions and pe­nal­ize non-mer­i­to­ri­ous fil­ers by in­sti­tut­ing time lim­its and as­so­ci­at­ed penal­ties,” and “im­prove the trans­paren­cy of the FDA’s re­view of cit­i­zen pe­ti­tions by re­quir­ing the agency to re­port more de­tails about de­lays and the agency’s re­view process.”

The sec­ond FDA au­thor­i­ty the au­thors looked at was “com­plex gener­ics,” which refers to small mol­e­cule non­bi­o­log­i­cal drugs that have dif­fi­cul­ty es­tab­lish­ing bioe­quiv­a­lence. One is­sue fac­ing com­plex gener­ics in­cludes FDA guid­ance on drug-de­vice com­bi­na­tions, al­so known as the “same­ness stan­dard” and trans­paren­cy.

Ac­cord­ing to the group, the FDA could “re­lax the same­ness stan­dard from sub­stan­tial equiv­a­lence to func­tion­al equiv­a­lence” on drug-de­vice com­bi­na­tions and stream­line the re­view of in­gre­di­ent same­ness for in­jectable com­plex gener­ics. They al­so point­ed to po­ten­tial leg­isla­tive op­tions in which the FDA could fur­ther clar­i­fy cer­tain as­pects.

The third and fi­nal is­sue ad­dressed was gener­ic drug park­ing, the prac­tice where com­pa­nies who are the first to get to the FDA with a gener­ic can­di­date pause at the ten­ta­tive ap­proval stage. The au­thors said that while some rea­sons for “park­ing” the prod­uct can be jus­ti­fied, they of­fered some sug­ges­tions to im­prove and in­cen­tivize more time­ly gener­ic en­try.

The first thing the au­thors sug­gest­ed was to amend pro­vi­sions sur­round­ing the ex­ist­ing, 180-day ex­clu­siv­i­ty re­ward for patent chal­lenges — and change it “to spec­i­fy a pre­sump­tion that any patent lit­i­ga­tion set­tle­ment be­tween gener­ic and brand firms that do not al­low for im­me­di­ate gener­ic en­try be viewed as grounds for for­fei­ture of the gener­ic’s 180-day ex­clu­siv­i­ty pe­ri­od.”

The au­thors added that this type of au­thor­i­ty could dis­cour­age more ob­scured forms of re­mu­ner­a­tion from brand to gener­ic firms (in­clud­ing MFEs and al­lowances to sell in for­eign mar­kets) and en­cour­age first-fil­ing gener­ic firms to en­ter be­cause de­lay­ing en­try will risk los­ing the ben­e­fit of ex­clu­siv­i­ty.

Sec­ond­ly, the sug­gest cre­at­ing ad­di­tion­al fi­nan­cial in­cen­tives to en­cour­age “at-risk launch­ing” by the first gener­ic fil­er, adding that a pos­si­bil­i­ty would in­clude hav­ing the Gov­ern­ment Ac­count­abil­i­ty Of­fice (GAO) ex­am­ine its op­tions. Those could in­clude grant­i­ng ad­di­tion­al ex­clu­siv­i­ty to gener­ic drugs that launch at-risk un­der cer­tain con­di­tions and their po­ten­tial ef­fects.

An­oth­er so­lu­tion to gener­ic drug park­ing was in­tro­duced to Con­gress as the BLOCK­ING Act three years ago, which was crit­i­cized by two ex-HHS at­tor­neys a few weeks ago.

The bill was orig­i­nal­ly writ­ten to pro­vide a workaround to gener­ic drug “park­ing.” In short, the bill would al­low the FDA to ap­prove gener­ic drugs from ri­val com­peti­tors who were not the first be­fore the agency if cer­tain con­di­tions were met, such as:

  • A sub­se­quent Para­graph IV AN­DA is ready for fi­nal ap­proval but for a first ap­pli­cant’s el­i­gi­bil­i­ty for 180- day ex­clu­siv­i­ty;
  • At least 30 months have passed since the first ap­pli­cant sub­mit­ted its AN­DA to FDA;
  • The 30-month patent lit­i­ga­tion stay of AN­DA ap­proval in­voked when patent in­fringe­ment lit­i­ga­tion is time­ly ini­ti­at­ed does not pre­clude ap­proval of a first ap­pli­cant’s AN­DA; and
  • FDA has not ap­proved a first ap­pli­cant’s AN­DA as of the date the first three re­quire­ments above are met.

So­cial im­age: Brook­ings In­sti­tu­tion via Brook­ings In­sti­tu­tion web­site

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.

Sanofi, GSK, Ha­le­on see stock prices dip and dive amid lit­i­ga­tion for re­called heart­burn drug

Zantac became one of the most well-known drugs on the market after being FDA-approved in 1983 — and now close to four decades later, lawsuits over safety concerns are rattling analysts and investors.

Sanofi, GSK and Haleon, GSK’s former consumer healthcare unit, have lost billions of dollars in market cap since Tuesday’s market close, according to Bloomberg. While Zantac is no longer on the market, the drop came after a suite of analysts, from Morgan Stanley and other firms, sounded the alarm on the potential impact of ongoing personal injury litigation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.