US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the glob­al bi­o­log­ics mar­ket is ex­pect­ed to hit near­ly the half-tril­lion-dol­lar mark this year, new JA­MA re­search points to the im­por­tance of time­ly biosim­i­lar en­try, par­tic­u­lar­ly as few­er biosim­i­lars are en­ter­ing the US than in Eu­rope, and as month­ly treat­ment costs for biosim­i­lars were “sub­stan­tial­ly high­er” in the US com­pared with Ger­many and Switzer­land.

Among the three coun­tries, biosim­i­lar mar­ket share at launch was high­est in Ger­many, but in­creased at the fastest rate in the US, the au­thors from the Uni­ver­si­ty of Zurich’s In­sti­tute of Law wrote in JA­MA Net­work Open to­day.

“In the US, up­take was high­est for be­va­cizum­ab (36%) and low­est for in­flix­imab (3%) 1 year af­ter mar­ket en­try,” they not­ed. “Up­take in Ger­many was high­est for adal­i­mum­ab (48%) [adal­i­mum­ab biosim­i­lars in the US don’t launch un­til next year] and low­est for in­sulin lispro (2%), where­as in Switzer­land, up­take was high­est for rit­ux­imab (25%) and low­est for in­sulin glargine (1%) 1 year af­ter mar­ket en­try.”

While not­ing that biosim­i­lar up­take in­creased steadi­ly across all three coun­tries from 2011 to 2020, the study on­ly eval­u­at­ed 15 biosim­i­lars and six bi­o­log­ics for the US, 52 biosim­i­lars and 15 bi­o­log­ics for Ger­many, and 28 biosim­i­lars and 13 bi­o­log­ics for Switzer­land.

The rel­a­tive lack of ex­pe­ri­ence so far in the US, as the path­way for biosim­i­lars wasn’t in­tro­duced in the US un­til 2012, al­so isn’t the cause for the gaps in price be­tween the Eu­ro­pean coun­tries and the US.

Ker­stin Vokinger

“We al­so made a sub-analy­sis com­par­ing costs for biosim­i­lars and bi­o­log­ics ap­proved in all three coun­tries (see Fig 4B, page 6) and the re­sults hold,” co-au­thor Ker­stin Vokinger told End­points News. “Thus, the high­er costs can­not be ex­plained with the BP­CIA cre­at­ed in 2012.”

In the con­clu­sion, they called for ne­go­ti­a­tions in the US to pro­hib­it ex­clu­sion­ary con­tracts in or­der to al­low biosim­i­lars to en­ter the mar­ket soon­er and at low­er costs, “which could re­sult in low­er health­care costs and im­proved pa­tient ac­cess.”

The in­tro­duc­tion of in­ter­change­able biosim­i­lars may al­so be key to lev­el­ing the play­ing field and dri­ving down costs, FDA lead­ers said re­cent­ly. Al­though on­ly 22 of 39 ap­proved biosim­i­lars have launched in the US, a re­cent re­port from Am­gen ap­prox­i­mates that they’ve cre­at­ed around $21 bil­lion in sav­ings over the last six years.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.